1. “ICD Patients/Recalled ICDS: What to do?” Gerald V. Naccarelli M.D.
Research support: Boston-Scientific, Medtronic, sanofi-aventis, Boehringer-Ingelheim, ARYX, Glaxo-Smith-Kline, St. Jude’s
Consultant: Glaxo-Smith-Kline, Medtronic, Boston-Scientific, Pfizer, Xention, sanofi-aventis, Wyeth-Ayerst, Novartis, Astellas, Cardiome, CV Therapeutics, Transoma, Paracor, Astra Zeneca

2. Electrophysiology Has Unique Issues
Industry-wide, product advisories since 2002 affected:
~650,000 devices1
~240,000 leads1
Potential risk of over-reaction: inappropriate surgery and underutilization of life-saving technology
Device innovation saves and improves lives each day
Despite proven benefits, all technology is subject to unexpected failure
Patient care decisions need to be evidence-based
Key Takeaway: Continuous improvement of devices brings increased benefits, but innovation has inherent risk.
Key Points:
Device innovation saves and improves more lives each day
Patient care decisions must rely on evidence-based medicine
Device advisories + societal factors lead to inappropriate patient care decisions
Patients sometimes choose not to have life-saving therapies, especially when they do not fully understand the risks and benefits.
Patient care decisions need to be evidence-based. That is how we manage innovation, device benefits and risks. What evidence do we have to guide us on the risks and benefits of medical device therapy?
1 Source: and internal research.
Note: private companies are estimates, given differences in disclosure rules for private companies versus public companies
How do physicians and industry manage innovation, device benefits and inherent risks?
1 Source: fda.gov.

3. Sudden Cardiac Death: ICDs Proven to Save Lives
SCD Risk
ICD Benefit
310,000
ICDs terminate 98% of fatal arrhythmias
ICDs are 99% reliable
ICDs are Class I indicated for most at-risk patients
SCA kills more than lung cancer, breast cancer, and AIDS combined
217,706
Lung Cancer
160,390
Breast Cancer
Key Takeaway: The risk/benefit of ICDs in SCD/SCA is well-established clinically, yet indicated patients are not receiving ICDs, so it must not be fully understood how much the benefit (survival) outweighs the risk.
Key Points:
SCA kills more than lung cancer, breast cancer, and AIDS combined
ICDs terminate life-threatening arrhythmias
Long-term product vigilance studies and returned product analysis, captured in the bi-annual Product Performance Reports, tell us that ICDs are over 99% reliable.
ACC/AHA guidelines tell us that ICDs are Class I indicated for most at-risk patients.
Without access to acute defibrillation, sudden cardiac arrest is 95% fatal.
Only defibrillation has been shown to prevent SCD.
Lung and Breast Cancer(1) American Cancer Society. Cancer Fact Sheets 2007 Estimates. Available at AIDS(2) Cases of HIV infection and AIDS in the United States and Dependent Areas, HIV/AIDS Surveillance Report, Volume 17, Revised Edition, June Table 7. SCD(3) American Heart Association website. Last updated 09/24/07.
ICDs are Class I indicated for most at-risk patients(4) Hunt SA, Abraham WT, Chin MH, et al. ACC/AHA 2005 guideline update for the diagnosis and management of chronic heart failure in the adult - summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure). Circulation. 2005;112:e154-e235.
41,000
AIDS
16,316
SCD
SCA is 95% fatal. Only defibrillation has been shown to prevent SCD.
Sources: American Cancer Society, American Heart Association, American College of Cardiology

4. Reductions in Mortality with ICDs
70%
60%
60%
54%
50%
37%
% Mortality Reduction
40%
36%
31%
31%
30%
23%
20%
20%
Reductions in mortality with ICDs vs. drugs:
VT/VF Patients
1 AVID: 31% at 3 years and 39% at 1 year (ICD versus empiric amiodarone or sotalol)
2 CASH: 37% at 2 years (ICD versus amiodarone, metoprolol or propafenone)
3 CIDS: 20% at 3 years (ICD versus amiodarone)
Post-MI Patients
4 MADIT: 54% at 2 years (ICDs versus conventional treatment – mostly amiodarone)
5 MUSTT: 60% at 5 years (ICDs versus conventional treatment – sotalol or amiodarone)
10% 0%
AVID1
3 Years
CIDS3
3 Years
MADIT4
2 Years
MUSTT5
5 Years
MADIT 2
3 Years
SCD-HeFT
5 Years
COMPANION
1 Year
CRT-D only - Secondary
CASH2
2 Years
1 The AVID Investigators. N Engl J Med. 1997;337: Connolly S. ACC98 News Online. April, Press release.
2 Kuck K. ACC98 News Online. April, Press release. 4 Moss AJ. N Engl J Med. 1996;335:

5. Pacemaker Innovation Over Last 4 Decades
1970
1 parameter
2008
> 200 parameters
Medical devices have come a long way in our lifetime. Most physicians practicing today were not around when pacemakers had one programmable parameter: the rate. You turned the handle one way, and the rate increased. You turned the handle the other way, and the rate decreased. Just having one rate to set the pacemaker at seems foreign to us now that we are used to being able to program over two hundred different parameters.
Key Takeaway: Through product innovation, there are over 200 different parameters that can be adjusted, for the potential to give each patient the maximum benefit from their pacemaker.
Key Points:
The picture on the left is a picture of the rotary (or “coffee grinder”) programmer that accompanied the 5931 and 5961 IPGs launched in the early 1970s.
Rate was the only programmable parameter at first
Now, there are over 200 programmable parameters
Pacemaker innovation has increased functionality for increased patient benefit
Note: The rotary (or “coffee grinder”) programmer accompanied the Medtronic 5931 and 5961 IPGs launched in the early 1970s.
Increasing Functionality, Increasing Benefit

6. ICD Innovation: Increasing Complexity With Smaller Device
1989
2008
Similarly, and a little more recently, ICDs have benefited from continuous engineering improvement. Twenty years ago, ICDs were huge 200 cc devices implanted in the abdomen. Today, ICDs are one fifth the size. Their incredible complexity is represented by the approximately 59 million transistors that layer together to form the newest Medtronic devices.
Key Takeaway: ICD innovation has resulted in devices that are 20% the size of the abdominally-implanted devices that were first launched, and contain much more functionality.
Key Points:
The latest ICDs (in the Vision 3D platform) have approximately 59 million transistors
Increasing complexity brings additional patient benefit
ICDs have decreased in size since introduction, but have increased in:
functionality
Battery longevity
complexity
ICDs today have ~59 million transistors

7. ICD Innovation and Continuous Improvement
209 cc
40 cc
1989
2008
Implant death rate
3.2%
< 1%
Implant infection rates
> 10%
Device battery longevity
1-2 years
8-9 years
Key Takeaway: ICD innovation, resulting from continuous improvement, means that patients benefit from lower implant death rates, lower implant infection rates, and substantially longer battery longevities.
Key Points:
ICDs are less than 1/5 the size
Implant death and infection rates have decreased
Battery longevity for Medtronic ICDs has increased to 8-9 years.
ICDs are proven 98% effective and 99% reliable.
98% effective:
1 Zipes DP. Circulation. July 1,1995;92(1):59-65
99% reliable:
2 Medtronic CRDM Product Performance Report, 1st Edition - Issue 56, January, 2007
Today, ICDs are proven 98% effective and 99% reliable
Sources: Zipes, Circulation, 1995 and Medtronic Product Performance Report.

8. ICDs and IPGs are Reliable
100.0%
99.985%
99.908%
99.5%
99.888%
99.562%
99.0%
98.5%
98.0%
97.5%
97.0%
Key Takeaway: ICDs and IPGs are over 99.5% reliable over 5 years.
Key Points:
One-year and five-year IPG data shows pacemakers are over 99.9% reliable.
One-year and five-year ICD data shows ICDs are over 99.5% reliable.
It is important to keep these numbers in mind when considering the reliability rates of other technology devices that we use every day.
Source: Medtronic Quality.
IPGs
ICDs
IPGs
ICDs
One-year
Five-year
2007 Medtronic pacemaker and ICD reliability data.

9. What are realistic expectations for device reliability?
Is 100% product reliability expected, or realistic?
How do we apply and assure consistent standards across the industry?
What should be done to set realistic expectations?
So what are realistic expectations for device reliability?
Key Takeaway: frame a discussion of the risk/benefit of implantable cardiac devices with thought questions.
Is 100% product reliability expected, or realistic?
How do we apply and assure consistent standards across the industry?
What should be done to set realistic expectations?

10. Unrealistic Expectations of Device Function by Physicians
Recent survey of heart rhythm specialists: up to 30% responding recommended replacement of ICDs if the malfunction rate was 1/10,000 (0.01%).
Experienced practitioners expect a very high degree of reliability of implantable devices.
Survey results suggest that both physicians and industry need to develop a consensus for dealing with the reality of malfunctions in manufactured devices.
Perfection of device function is assumed and desirable although this manufacturing gold standard can never be reached
In 1997, ICDs had Expected Life Reliability of 93% at 3 years and an average failure rate of 0.20% failures/month.
Current Expected Life Reliability for ICDs is 96.18% at 5 years and average failure rate is 0.065% failures/month.
We will continue to approach 100% reliability but never achieve it
Maisel WH. PACE 2004; 27:

11. and Pacemakers Explanted After Recalls
ICDs
and Pacemakers Explanted After Recalls
[Mean Percent of Subject Products Explanted after Recalls]
39%
MDT = Medtronic
GDT = Guidant 40
33% 35
31%
27% 30
24% 25
Percent 20 15 10 5
MDT
MDT
GDT
GDT
GDT
Marquis
MarquisC
Prizm2 DR
Contak
Pacemakers
ICD RT - D
ICD
Renewal
CRT - D
[Reproduced courtesy of Eric
Prystowsky
, MD. These data are based on the reported experience of 37 imp
lanting physicians who
responded to a survey on this question, and may not reflect gene
ral experience or that subsequent to the survey. The data were
presented at the HRS/FDA
Policy Conference on Pacemaker and ICD Performance
, Washington, DC, September 16, 2005.]

12. High Replacement Rates Due to Physicians Lack of Understanding
“The experience with a low-frequency rate of malfunctions, in the setting of defined clinical benefits of the therapy, creates a broad range of dilemmas. The major conflict is between the financial impact of an aggressive replacement policy on corporate business and the fiscal status of the health care system and the ethical drive to preserve a single life, in accordance with individual patient preferences. Despite the low probability of manifest adverse events, high replacement rates occurred as a result of potential device malfunctions for a number of devices recently reported by device manufacturers. These numbers speak to the absence of a baseline of information that would provide clinicians with a balanced insight into the entire scope of the issue, in the context of risk/benefit ratios. It is likely that clinical judgment would drive the numbers down, with appropriate physician awareness and education on actual risk. “
Guidant Independent Panel Report

13. Importance of Root Cause Analysis
Sigma
Exhaustive Root Cause Search, Thousands of Variables and Scenarios
Affected devices implanted around two time periods
Isolated specific manufacture dates
Discovered outside supplier’s cleaning solvent contained anti-oxidant additive not present in previous shipments
Key Takeaway: Root Cause Analysis defined why the failure happened, and greatly reduced the potential number of devices impacted.
Often overlooked in the quality discussion is the ability of a manufacturer to find root cause and recommend appropriate physician based action. In searching through the thousands of variables and scenarios that could have caused or lead to this difference between affected and unaffected devices, it was discovered that the Terpene used in our normal hybrid cleaning process contained an anti-oxidant additive which was not present in previous shipments of Terpene provided by an outside supplier. This anti-oxidant reacted with metallic surface, impacting wire adhesion. Specific dates these impacted devices went through the manufacturing process were isolated, helping to quickly identify those devices and patients affected while ruling out risk and concern for thousands of other unaffected Sigma device patients.
Key Point: Root Cause Analysis discovered that Terpene used in normal cleaning process contained anti-oxidant additive not present in previous shipments from outside supplier.
Root Cause Analysis reduced from a potential > 165,000 US Sigma IPGs to 6,650 active US implants

14. First indication of potential battery issue, root cause unknown
Marquis
April 2001
January 2003
JAN 2003: battery shorts while being used to test new manufacturing equipment
April 2008
APR 2001: Marquis launched
Case purpose: The purpose of this case study is to illustrate the patient management impact of physicians correctly understanding (a) root cause and (b) patient management recommendations.
Key takeaway from slide: A battery short was observed while new manufacturing equipment was being tested; at this point, no field failures of this mechanism were observed yet.
Key Points:
Marquis was launched in April 2001
In January 2003, one battery exhibited the venting mechanism during the new manufacturing line testing
This line testing was to qualify new equipment; it was not designed to test the battery
When first observed, the root cause was unknown
There were no field failures reported yet
No field failures observed
First indication of potential battery issue, root cause unknown

15. Random Component Failures
Marquis
All technology has an inherent rate of failure
Important to understand if failure is random
Root cause analysis reveals the mechanism of failure in 65%1 of cases
1/10,0002 devices incur a random component failure
Case purpose: The purpose of this case study is to illustrate the patient management impact of physicians correctly understanding (a) root cause and (b) patient management recommendations.
Key takeaway from slide: It is part of the engineering process to try to understand the root cause of device component failure, if possible.
Key Points:
All technology has an inherent rate of failure.
The overall rate is a sum of the inherent rate of failure of each individual component of the overall device
Industry-wide, it has been observed that approximately 1/10,000 devices incur a random component failure
Despite best efforts, random failures still occur
1 Guidant data.
2 Maisel. JAMA

16. Mesh Anode Grid Shorting Mechanism
Marquis
Cathode Crack
Ragged edge of
cathode crack
Separator
Grid hole
Separator compressed
between edges of
cathode crack and
hole in anode grid
Crack in cathode
grid hole
Case purpose: The purpose of this case study is to illustrate the patient management impact of physicians correctly understanding (a) root cause and (b) patient management recommendations.
Key takeaway from slide: It was determined that the observed short was permitted by the mesh grid design.
Key Points, bottom right graphics:
The black layer is the cathode
The orange layer is the separator (it is a thin paper separator)
There is another layer in the picture above the separator to represent the anode (it is not directly attached to the can.) It was left out of this picture to simplify.
The holes in the grid have edges.
When the lithium reacts with the Vanadium Oxide, a gas is produced that makes the battery swell.
The swelling pushes the battery against the edges of the holes and this can create the short.
As the battery is used, the gas accumulates, so the short was more likely to occur later in the battery life.
At the time this was determined, there were still no field failures observed.

17. Approved Design Changes
Marquis
New Battery Design Testing
Battery Design
Batteries Tested
Shorts Observed
Comment
Original
Mesh Grid
> 2800 27
Rate of shorting under highly accelerated testing is variable across population
New Solid Grid
> 2700
Instituted new design
Anode Grid
Solid anode current collector removes edges in previous design
Additional 3.5mil spacer added to increase distance between anode current collector and cathode
Case purpose: The purpose of this case study is to illustrate the patient management impact of physicians correctly understanding (a) root cause and (b) patient management recommendations.
Key takeaway from slide: Over 5,500 batteries were tested in developing a new battery design that eliminated the still-theoretical shorting mechanism.
Key Points:
Over 5,500 batteries tested
Solid anode current collector replaced mesh grid design
Additional spacer was added
Still no field failures observed
Theoretic clinical shorting mechanism solved

18. * First Field Failures Potential concern of device reliability raised
Marquis
Sept 2004
April 2001
April 2008
APR 2004 First failure confirmed
DEC 2004
Timeline of Marquis Battery Confirmations
Between September and December, 8 additional device failures confirmed
Exceeds typical random component failure rate
Mar-04
Jun-04
Sept-04
Jan-05
Calendar Date *
Case purpose: The purpose of this case study is to illustrate the patient management impact of physicians correctly understanding (a) root cause and (b) patient management recommendations.
Key takeaway from slide: In April 2004, the first field failure due to the battery shorting mechanism was confirmed, and by December 2004, there were nine total confirmed failures of this mechanism, raising it above the random failure rate discussed previously.
Key Points:
First failure due to this battery shorting mechanism confirmed in April 2004
Next failure confirmed in September 2004
Seven more totaled 9 total failures by December 2004.
This exceeded random failure rate and raised the potential for concern about device reliability
Note: Timeline represents the date RC Informed of Shorting Mechanism by MECC.
Potential concern of device reliability raised

19. Results of Bench Testing
Marquis
DEC 2004 – JAN 2005
April 2001
April 2008
Case purpose: The purpose of this case study is to illustrate the patient management impact of physicians correctly understanding (a) root cause and (b) patient management recommendations.
Key takeaway from slide: At the time, the best available data modeled a 0.2% - 1.5% risk, with 96% of the shorts projected to occur in the second half of the device life.
Key Points:
Analysis of results from testing suggested that failure rates over the device life may increase over time to 0.2% up to 1.5%.
If failure rates were to increase they would increase during the second half of the expected life of the battery
Independent Medical Advisors panel assembled to provide clinical recommendations to Medtronic
Challenges in building a model to project performance include:
Because there was no prior history, the accelerated testing that was done to recreate the shorting mechanism was the best approximation deemed possible
The assumption was that the accelerated test is more severe than real life
The actual relationship between accelerated testing and real life current drain was approximated by the testing done, and represented in the curves shown
Source: UC EN
Available data modeled a 0.2% - 1.5% risk

20. Independent Medical Advisory Panel
Marquis
April 2001
April 2008
JAN - FEB 2005
Panel actions:
Reviewed results of extensive device testing
Unanimously recommended product advisory
Assisted with patient management recommendations
Case purpose: The purpose of this case study is to illustrate the patient management impact of physicians correctly understanding (a) root cause and (b) patient management recommendations.
Key takeaway from slide: Involvement of the Independent Medical Advisors was key for providing clinical insight.
Key Points:
Analysis of 0.2%-1.5% risk at end of expected device life shared with Panel
Panel unanimously recommended product advisory
Panel assisted with patient management recommendations
Panel integral to recall and patient management recommendations

21. Patient Management
Marquis
April 2001
April 2008
FEB 2005
Medtronic Recommended Physicians Consider the Following Patient Management Options:
Continue to conduct routine follow-up
Turn on Patient Alert™ indicator
Patients should seek care if they experience warmth in the ICD area
Consider providing a handheld magnet to patients
Should the physician decide to replace an affected device in a specific patient (e.g., a patient who is pacemaker dependent), Medtronic will provide a device at no cost
Case purpose: The purpose of this case study is to illustrate the patient management impact of physicians correctly understanding (a) root cause and (b) patient management recommendations.
Key takeaway from slide: Medtronic incorporated independent medical advisor panel recommendations to issue patient management recommendations in conjunction with product advisory issued in February 2005.
Patient Management Recommendations included:
Continue to conduct routine follow-up
Turn on Patient Alert™ indicator
Patients should seek care if they experience warmth in the ICD area
Consider providing a handheld magnet to patients
Should the physician decide to replace an affected device in a specific patient (e.g., a patient who is pacemaker dependent), Medtronic will provide a device at no cost

22. Physician Over-reaction to Product Advisory
Marquis
April 2001
April 2008
Advisory Communicated
FEB – SEPT 2005
US Marquis Returns
Case purpose: The purpose of this case study is to illustrate the patient management impact of physicians correctly understanding (a) root cause and (b) patient management recommendations.
Key takeaway from slide: Within six months after the product advisory was issued, there were 20,000 devices explanted, despite patient management recommendations.
Key Points:
This chart shows that there is a low level of product that is returned in normal circumstances
Reasons why product can be returned includes normal ERI, etc.
Many times more devices were explanted after the product advisory was communicated
20,000 devices explanted within 6 months

23. Only known patient injuries resulted from explants
Early Explant of ICDS Resulted in More Adverse Effects than Just Monitoring Patient As Per Advisory
Marquis
April 2001
September 2005
April 2008
US Device returns
Patient impact:
Confirmed failures = 95
37,000 devices explanted worldwide
Known patient injuries from field failures = 0
Failure rates:
Last half of device life at lower bounds of forecast (~ 0.2%)
Total observed battery shorting mechanism (Mar-08) is 0.09%
Case purpose: The purpose of this case study is to illustrate the patient management impact of physicians correctly understanding (a) root cause and (b) patient management recommendations.
Key takeaway from slide: As of April 2008, there are no known patient injuries from field failures.
Key Points:
The rate of explantation decreased after the initial six months, but still continued
95 total confirmed failures
37,000 Marquis devices were explanted worldwide – many in the first half of the projected device life
Known patient injuries from field failures = 0
Currently, the last half of device life failure at lower bounds of forecast (~ 0.2%)
Total device failure due to this mechanism is 0.09% (Mar-08)
First 6 months of Advisory
Only known patient injuries resulted from explants
April 2001

24. CRDM Product Performance Report, 2nd edition 2007.
Marquis Performance
Marquis
CRDM Product Performance Report, 2nd edition 2007.
Case purpose: The purpose of this case study is to illustrate the patient management impact of physicians correctly understanding (a) root cause and (b) patient management recommendations.
Key takeaway from slide: This chart from the Product Performance Report shows the device survival at 63 months
Key Points:
AT 5 years there was a 1.8% increased risk of ICD malfunction

25. Risk/Benefit of Intervention
Table 4. Complications From 533 Elective Advisory Device Replacements
Severity and Complications No. (%)*
Minor 9 (1.7) Incisional infection, medically managed Significant site pain, medically 1 (0.2) managed Heart failure requiring admission 1 (0.2) Major psychological morbidity, 1 (0.2)
Major Pocket infection requiring 10 (1.9) extraction Postextraction deaths 2 (0.4) Hematoma requiring reoperation 12 (2.3) System malfunction requiring 8 (1.5) reoperaton Significant site pain requiring 1 (0.2) reoperation
*Number of patients with the complication.
“ICD generator replacement in patients with advisory devices is associated with a substantial rate of complications, including death. These complications need to be considered in the development of guidelines determining the appropriate treatment of patients with advisory devices.”
Results from the 17 surveyed centers:
2915 patients had recall devices
533/2915 (18.3%) had advisory ICDs replaced
Mean replacement time after initial implant: 26.5 (11.5 SD) months
66% of patients with replacements had a secondary prevention ICD
45% of patients with replacements had received a previous appropriate shock.
43/533 (8.1%) had complications
31/43 patients had major complications attributable to advisory device replacement requiring reoperation
2/43 patients died after extraction for pocket infection
12/43 patients had minor complications
3 advisory-related device malfunctions reported, without clinical consequences.
“Complications Associated With Implantable Cardioverter-Defibrillator Replacement in Response to Device Advisories.” Gould, et. al. for the Canadian Heart Rhythm Society Working Group on Device Advisories. JAMA, April 26, 2006—Vol 295, No. 16
Gould, et al. JAMA Canadian Heart Rhythm Society Working Group on Device Advisories.
1Krahn et al, JAMA 2006:295

26. Is a 5.8% Major Complication Rate a Risk Reasonable For Early Replacement of “Recalled Device”?
Advisory
Risk of Failure
Medtronic Marquis ICD
Accelerated battery depletion from internal battery short
0.01%
Guidant Ventak Prizm 2 DR ICD
Short circuit caused by wire insulation problem
0.1%
Guidant Ventak Prizm, Vitality, Contak Renewal AVT ICDs
Random memory error limiting delivery of therapies
00095%
Guidant Contak Renewal 3,4; 3,4 AVT; RF ICDs
Magnetic switch faulty limiting delivery of therapies
0.009%
St. Jude Photon DR; Micro VR/DR; Atlas VR/DR ICDs
Memory chip affected by cosmic radiation limiting delivery of therapies
0.167%
ELA Alto ICD
Metal migration that can impair delivery of therapies
2.6%
Gould PA, et al. JAMA 2006;295:

27. Cost/Risk of ICD Advisory Explant
533 ICDs replaced $20,000 each = $10,660,000
Your Canadian tax dollars at work
8.1% complications
2 deaths and 8 other patients that no longer have an ICD due to device extraction for infection
Benefit: 3 devices had minor issues that were not life threatening
Let me know when complete transparency is a good idea?
*Gould PA, et al. JAMA 2006;295:

28. ICD Replacement Complications in Response to Recall Advisories
533/2915 (18.3%) had advisory ICDs replaced
During a 2.7 month mean follow-up, complications occurred in 43 patients(8.1%)
Major complications occurred in 31 patients (5.8%)
2 deaths after pocket extraction of infected device
Pocket infection requiring extraction 10 (1.9%)
There were 3 device (0.1%) advisory-related device malfunctions, without clinical consequence
Gould PA, et al. JAMA 2006;295:

29. Decision Models for Any IPG or ICD Device Replacement
Results:
Decision to replace a recalled device depends on:
Primary factors: Advisory's estimated device failure rate and likely effects of device failure on mortality
Secondary factor: procedural mortality
Least influence: patient age and remaining generator life
Conclusions:
Device replacement warranted when advisory device failure rates exceed:
0.3% (IPG) for pacemaker-dependent patients
3% (ICD), decreasing to 0.1% as risk of fatal arrhythmias increase to near 20% per year
"device replacement in the setting of an advisory is not inconsequential and frequently has a greater risk than continued device follow-up"
Amin M, Matcher D, Wood M, Ellenbogen KA. JAMA 2006;296:

30. Risk/Benefit of Intervention
Table 1. Current ICD Advisories Included in the Survey and Associated Risk
Date Current Risk Company/Device* of Advisory Advisory Issue† of Failure, %†
Medtronic February 2005 Accelerated battery depletion caused Marquis ICD by internal battery short
Guidant Ventak Prizm 2 DR ICD June 2005 Short circuit caused by wire insulation problem within lead connector block
Guidant Ventak Prizm AVT, Vitality AVT, June 2005 Random memory error, limited delivery and Contak Renewal AVT ICDs of therapies
Guidant Contak Renewal 3, 4, Renewal 3, June 2005 Magnetic switch faulty, impairing delivery AVT, and Renewal RF ICDs of therapies
St. Jude Photon DR, Photon Micro VR/DR, October 2005 Memory chip affected by atmospheric and Atlas VR/DR ICDs radiation, which can impair pacing and delivery of therapies
ELA Alto ICD August 2001 Migration of metal, which can impair 2.6‡ pacing and delivery of therapies 0.1§
1908 JAMA, April 26, 2006—Vol 295, No. 16 (Reprinted) ©2006 American Medical Association. All rights reserved.
Please note that this article was published in April 2006 for Marquis performance data comparisons.
“Complications Associated With Implantable Cardioverter-Defibrillator Replacement in Response to Device Advisories.” Gould, et. al. for the Canadian Heart Rhythm Society Working Group on Device Advisories. JAMA, April 26, 2006—Vol 295, No. 16
Abbreviation: ICD, implantable cardioverter-defibrillator. *Predominantly subpopulation of listed devices affected by advisory. †Data obtained from physician communications and public statement releases such as those from Medtronic and Guidant. The current risk of failure represents the number of failures divided by the number of devices implanted at the time of advisory disclosure. ‡manufactures between April and July §Manufactured between August 2003 and August 2004.

31. Consensus on approach to future advisories
HRS Guidelines
The Heart Rhythm Society believes that patient and physician
knowledge, confidence, and trust can be enhanced and strengthened
through:
• Transparency in post-market surveillance, analysis, and reporting of information,
• Systems to increase the return of devices to manufacturers and to improve the analysis and reporting of device performance and malfunction information, and
• Cooperation among industry, the FDA, and physicians to make every effort to prevent injuries and deaths due to device malfunctions
Be sure to define “transparency” to the audience.
Heart Rhythm Society Task Force on Device Performance Policies and Guidelines April 26, 2006
Consensus on approach to future advisories

32. Sprint Fidelis versus Quattro® Lead SLS Survival Probability
As stated in the October 15, 2007 letter to physicians:
Returned Product Analysis (RPA) of Sprint Fidelis® leads shows a survival of 99.2% at 30 mos. However, RPA overstates actual performance since it does not account for leads that are not returned. The Medtronic Systems Longevity Study data for the Model 6949 Sprint Fidelis lead indicate 97.7% [+1.3/-3.0] all-cause lead survival at 30 mos. This is consistent with our analysis of Medtronic CareLink Network data from approximately 25,000 Sprint Fidelis leads, which indicate 97.7% [+0.6/-0.8] survival at 30 mos. These survival rates are not statistically different from the all-cause lead survival of 99.1% [+0.4/-0.8] for the Model 6947 Sprint Quattro® lead at 30 mos. from the SLS. However, we expect this difference will become statistically significant over time if the current failure rates remain constant.
Source: October 15, 2007 letter, Appendix I.

33. Sprint Fidelis Lead Advisory
Independent physician advisory panel consulted
Reviewed analyses of returned product, System Longevity Study information and data from over 25,000 CareLink-enrolled patients
97.7% all-cause lead survival at 30 months
268,000 implants
Key Takeaway: After consulting the independent physician advisory panel, Medtronic chose to voluntarily suspend distribution of the Sprint Fidelis leads.
Key Points:
An independent physician advisory panel was convened to review analyses of data from various sources
These sources included System Longevity Study, Returned Product Analysis and CareLink
The 6949 was shown to be performing the lowest, with 97.7% all-cause lead survival at 30 months
The Fidelis survival rates compared with Quattro did not show statistical difference when the analysis was completed in October 2007
However, Medtronic expected the difference between Fidelis and Quattro would become statistically significant over time if the current failure rates remained constant
Urgent Medical Device Information
Sprint Fidelis® Lead Patient Management Recommendations
October 15, 2007
Dear Doctor,
This letter provides important information on Sprint Fidelis lead performance and recommendations for ongoing patient management. Our records indicate that you have implanted or are following patients with Sprint Fidelis leads (Models 6930, 6931, 6948, 6949). In consultation with our Independent Physician Quality Panel, we are voluntarily suspending distribution of Sprint Fidelis leads worldwide. This decision is based on a variety of factors detailed in this letter that when viewed together, indicate that suspension of implantation is the appropriate action. You should no longer implant Sprint Fidelis leads, and you should return any unused product to Medtronic.
Background
As we reported in March 2007, there are two primary locations1 where chronic conductor fractures have occurred on Sprint Fidelis leads: 1) the distal portion of the lead, affecting the anode (ring electrode) and 2) near the anchoring sleeve tie-down, predominantly affecting the cathode (helix tip electrode), and occasionally the high voltage conductor. High voltage conductor fractures could result in the inability to deliver defibrillation therapy. Anode or cathode conductor fractures (at either location) may present clinically as increased impedance, oversensing, increased interval counts, multiple inappropriate shocks, and/or loss of pacing output. The potential for defibrillation lead fracture to result in or contribute to inappropriate therapies or death has been previously reported.2 As of October 4, 2007, there have been approximately 268,000 Sprint Fidelis leads implanted worldwide. Based on current information, we have identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor. We have confirmed 665 chronic fractures in returned leads. Approximately 90% of these fractures have occurred in the anode or cathode conductors, while 10% have occurred in the high voltage conductors.
Performance Update
Since our March 21st communication, we have examined six months additional Returned Product Analysis (RPA) and Medtronic System Longevity Study (SLS) data. In addition, we have performed extensive analysis using the Medtronic CareLink® Network (25,000 devices) [see Appendix A]. These data give us confidence in our current understanding of Sprint Fidelis’ performance.
RPA of Sprint Fidelis leads shows a survival of 99.2% at 30 months. However, RPA overstates actual performance since it does not account for leads that are not returned. The Medtronic SLS data for the Model 6949 Sprint Fidelis lead indicate 97.7% [+1.3/-3.0] all-cause lead survival at 30 months. This is consistent with our analysis of Medtronic CareLink Network data from approximately 25,000 Sprint Fidelis leads, which indicate 97.7% [+0.6/-0.8] survival at 30 months. These survival rates are not statistically different from the all-cause lead survival of 99.1% [+0.4/-0.8] for the Model 6947 Sprint Quattro® lead at 30 months from the SLS (see Appendix B). However, we expect this difference will become statistically significant over time if the current failure rates remain constant.
Recommendations
Medtronic recommends you consider the following as part of routine follow-up for each patient (see AppendixC)
To reduce the risk of inappropriate detection and therapy due to oversensing, program VF detection for initial Number of Intervals to Detect (NID) to nominal settings (18/24) or longer at physician discretion and Redetect NID to nominal settings (12/16).
Turn ON Patient Alert™ for RV Pacing, RV Defibrillation, and SVC Defibrillation impedance. For Concerto® and Virtuoso® devices enrolled on the Medtronic CareLink™ Network, turn ON the CareLink CareAlert® notifications for these same parameters
To optimize effectiveness of the lead impedance alert:
Review V Pacing Lead Performance Trend to determine typical chronic impedance value for the patient (typical values for Fidelis leads should be 350-1,000 ohms).
Program lead impedance alert threshold for RV Pacing to 1,000 ohms, if the typical chronic impedance for the patient is ≤ 700 ohms, or
Program lead impedance alert threshold for RV Pacing to 1,500 ohms, if the typical chronic impedance for the patient is > 700 ohms.
Program lead impedance alert threshold for RV Defibrillation and SVC Defibrillation to 100 ohms.
The patient management recommendations set forth above should increase the likelihood that a fracture will be detected by Patient Alert and/or Medtronic CareAlert notifications and decrease the likelihood of inappropriate therapies. Based on our review of the available data, there does not appear to be a benefit to more frequent follow-up.
Medtronic’s Independent Physician Quality Panel believes it is inappropriate to prophylactically remove Sprint Fidelis leads except in unusual individual patient circumstances.We support this position.
Lead extraction carries risks that should be considered in patient management. Published literature suggestsmajor complications (death or surgical intervention) from lead extraction range from %.3,4 As always, with confirmed lead failure the risk of extraction should be weighed against the risk of adding an additional lead (see Appendix D).
Additional Communication
The HRS-recommended Physician Device Advisory Notice for this communication is attached. The information in this letter will be posted on Medtronic.com on October 15th. Consistent with the HRS5 recommendations on device advisory communications we will be informing patients with affected devices, advising them to contact you for more information. The patient letter will be sent on October 22nd.
We are notifying regulatory agencies of this communication. We will continue to provide performance updates every six months via our Product Performance Report.
Nothing is more important to Medtronic than patient safety. We are committed to answering your questions and keeping you informed. We regret any difficulties this may cause you and your patients. If you have questions or concerns, please contact your Medtronic Representative or Medtronic Technical Services at 1(800) (US).
Sincerely,
Reggie Groves
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Disease Management
Appendix Document Attached
1 The two primary locations described above account for 90% of the chronic fractures identified by RPA. The remaining 10% of chronic fractures occurred in DF-1 connector leg and the proximal portion of the RV coil.
2 Kleemann T, Becker T, Doenges K, et al., K. Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of >10 years. Circulation. May 15, 2007; 115(19):
3 Byrd CL, Wilkoff BL, et al. Intravascular extraction of problematic or infected permanent pacemaker leads: U.S. Extraction Database, MED Institute. PACE May 2000; 23(5):
4 Bracke FA, Meijer A, vanGelder LM. Lead extraction for device related infections: a single centre experience. Europace, May 2004; 6(3):
5 Recommendations from the HRS task force on device performance policies and guidelines. Carlson MD, et al. Heart Rhythm Journal 2006, 3,
If you have questions or concerns, please contact your Medtronic Representative or Medtronic Technical Services at (US).
Voluntarily suspended distribution of leads (October 2007)

34. Sprint Fidelis Lead Patient Management Recommendations
Programming parameters to:
Improve effectiveness of lead impedance alert
Reduce likelihood of inappropriate shocks
Independent Physician Quality Panel believed prophylactic removal inappropriate except in unusual circumstances
Lead extraction risk from published literature suggests major complications range from 1.4–7.3%1,2
Key Takeaway: Medtronic issued patient management recommendations to physicians based on published risk of lead extraction.
Key Points:
Programming parameters were recommended to improve the effectiveness of the lead impedance alert and reduce the likelihood of inappropriate shocks
Initial programming parameter changes were expected to provide two days advance notice prior to inappropriate therapy to 49% of patients with lead fractures
Both the Independent Physician Quality Panel and the FDA believed prophylactic removal was inappropriate except in unusual circumstances due to published extraction-risk rates
Sources:
1 Byrd CL, Wilkoff BL, et al. Intravascular extraction of problematic or infected permanent pacemaker leads: U.S. Extraction Database, MED Institute. PACE May 2000; 23(5): Bracke FA, Meijer A, vanGelder LM. Lead extraction for device related infections: a single centre experience. Europace, May 2004; 6(3):
Urgent Medical Device Information
Sprint Fidelis® Lead Patient Management Recommendations
October 15, 2007
Dear Doctor,
This letter provides important information on Sprint Fidelis lead performance and recommendations for ongoing patient management. Our records indicate that you have implanted or are following patients with Sprint Fidelis leads (Models 6930, 6931, 6948, 6949). In consultation with our Independent Physician Quality Panel, we are voluntarily suspending distribution of Sprint Fidelis leads worldwide. This decision is based on a variety of factors detailed in this letter that when viewed together, indicate that suspension of implantation is the appropriate action. You should no longer implant Sprint Fidelis leads, and you should return any unused product to Medtronic.
Background
As we reported in March 2007, there are two primary locations1 where chronic conductor fractures have occurred on Sprint Fidelis leads: 1) the distal portion of the lead, affecting the anode (ring electrode) and 2) near the anchoring sleeve tie-down, predominantly affecting the cathode (helix tip electrode), and occasionally the high voltage conductor. High voltage conductor fractures could result in the inability to deliver defibrillation therapy. Anode or cathode conductor fractures (at either location) may present clinically as increased impedance, oversensing, increased interval counts, multiple inappropriate shocks, and/or loss of pacing output. The potential for defibrillation lead fracture to result in or contribute to inappropriate therapies or death has been previously reported.2 As of October 4, 2007, there have been approximately 268,000 Sprint Fidelis leads implanted worldwide. Based on current information, we have identified five patient deaths in which a Sprint Fidelis lead fracture may have been a possible or likely contributing factor. We have confirmed 665 chronic fractures in returned leads. Approximately 90% of these fractures have occurred in the anode or cathode conductors, while 10% have occurred in the high voltage conductors.
Performance Update
Since our March 21st communication, we have examined six months additional Returned Product Analysis (RPA) and Medtronic System Longevity Study (SLS) data. In addition, we have performed extensive analysis using the Medtronic CareLink® Network (25,000 devices) [see Appendix A]. These data give us confidence in our current understanding of Sprint Fidelis’ performance.
RPA of Sprint Fidelis leads shows a survival of 99.2% at 30 months. However, RPA overstates actual performance since it does not account for leads that are not returned. The Medtronic SLS data for the Model 6949 Sprint Fidelis lead indicate 97.7% [+1.3/-3.0] all-cause lead survival at 30 months. This is consistent with our analysis of Medtronic CareLink Network data from approximately 25,000 Sprint Fidelis leads, which indicate 97.7% [+0.6/-0.8] survival at 30 months. These survival rates are not statistically different from the all-cause lead survival of 99.1% [+0.4/-0.8] for the Model 6947 Sprint Quattro® lead at 30 months from the SLS (see Appendix B). However, we expect this difference will become statistically significant over time if the current failure rates remain constant.
Recommendations
Medtronic recommends you consider the following as part of routine follow-up for each patient (see AppendixC)
To reduce the risk of inappropriate detection and therapy due to oversensing, program VF detection for initial Number of Intervals to Detect (NID) to nominal settings (18/24) or longer at physician discretion and Redetect NID to nominal settings (12/16).
Turn ON Patient Alert™ for RV Pacing, RV Defibrillation, and SVC Defibrillation impedance. For Concerto® and Virtuoso® devices enrolled on the Medtronic CareLink™ Network, turn ON the CareLink CareAlert® notifications for these same parameters
To optimize effectiveness of the lead impedance alert:
Review V Pacing Lead Performance Trend to determine typical chronic impedance value for the patient (typical values for Fidelis leads should be 350-1,000 ohms).
Program lead impedance alert threshold for RV Pacing to 1,000 ohms, if the typical chronic impedance for the patient is ≤ 700 ohms, or
Program lead impedance alert threshold for RV Pacing to 1,500 ohms, if the typical chronic impedance for the patient is > 700 ohms.
Program lead impedance alert threshold for RV Defibrillation and SVC Defibrillation to 100 ohms.
The patient management recommendations set forth above should increase the likelihood that a fracture will be detected by Patient Alert and/or Medtronic CareAlert notifications and decrease the likelihood of inappropriate therapies. Based on our review of the available data, there does not appear to be a benefit to more frequent follow-up.
Medtronic’s Independent Physician Quality Panel believes it is inappropriate to prophylactically remove Sprint Fidelis leads except in unusual individual patient circumstances.We support this position.
Lead extraction carries risks that should be considered in patient management. Published literature suggestsmajor complications (death or surgical intervention) from lead extraction range from %.3,4 As always, with confirmed lead failure the risk of extraction should be weighed against the risk of adding an additional lead (see Appendix D).
Additional Communication
The HRS-recommended Physician Device Advisory Notice for this communication is attached. The information in this letter will be posted on Medtronic.com on October 15th. Consistent with the HRS5 recommendations on device advisory communications we will be informing patients with affected devices, advising them to contact you for more information. The patient letter will be sent on October 22nd.
We are notifying regulatory agencies of this communication. We will continue to provide performance updates every six months via our Product Performance Report.
Nothing is more important to Medtronic than patient safety. We are committed to answering your questions and keeping you informed. We regret any difficulties this may cause you and your patients. If you have questions or concerns, please contact your Medtronic Representative or Medtronic Technical Services at 1(800) (US).
Sincerely,
Reggie Groves
Vice President, Quality and Regulatory
Medtronic Cardiac Rhythm Disease Management
Appendix Document Attached
1 The two primary locations described above account for 90% of the chronic fractures identified by RPA. The remaining 10% of chronic fractures occurred in DF-1 connector leg and the proximal portion of the RV coil.
2 Kleemann T, Becker T, Doenges K, et al., K. Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of >10 years. Circulation. May 15, 2007; 115(19):
3 Byrd CL, Wilkoff BL, et al. Intravascular extraction of problematic or infected permanent pacemaker leads: U.S. Extraction Database, MED Institute. PACE May 2000; 23(5):
4 Bracke FA, Meijer A, vanGelder LM. Lead extraction for device related infections: a single centre experience. Europace, May 2004; 6(3):
5 Recommendations from the HRS task force on device performance policies and guidelines. Carlson MD, et al. Heart Rhythm Journal 2006, 3,
If you have questions or concerns, please contact your Medtronic Representative or Medtronic Technical Services at (US).
1 Byrd CL, Wilkoff BL, et al. PACE May Bracke FA, et al. Europace, May 2004.

35. Sprint Fidelis Update – May 2008
Medtronic continues Performance trend reported May 2008 continues as described in October 2007 communication
Patient management recommendations remain unchanged
Future plans include:
Device enhancement with Lead Integrity Alert (pending FDA Approval)
Quarterly updates posted to Internet
Key Takeaway: On May 7, 2008, Medtronic issued a Sprint Fidelis Lead Performance Update that lead performance continues to be in line with the information provided in October 2007.
Key Points:
Performance trend continues as described in the October communication
Patient management recommendations remain unchanged
Future plans include device enhancements and additional information to improve patient management.
Device enhancements consist of software that can be downloaded into approximately 93% of Medtronic implanted devices worldwide (98% in the US) to increase the likelihood of fracture detection prior to inappropriate therapy. Approximately 75% of patients should get three or more days notice with the new software. The software will be available later this year, subject to regulatory approval.
Quarterly performance updates will be posted on the Medtronic website beginning in August at

36. Lead Integrity Alert (LIA)
Fidelis
LIA will increase the likelihood of fracture detection prior to inappropriate therapy
Prior to LIA, approximately 49% of Sprint Fidelis lead patients are expected to receive an alert two or more days prior to inappropriate therapy due to a lead fracture.
With the Lead Integrity Alert, approximately 75% of Sprint Fidelis lead patients will receive an alert three or more days prior to inappropriate therapy due to a lead fracture.
Key Takeaway: On May 7, 2008, Medtronic announced that it is working on a software enhancement currently being called the “Lead Integrity Alert.”
Key Points:
The software will be available later this year, subject to regulatory approval.
The Lead Integrity Alert is new software that can be downloaded into approximately 93% of Medtronic implanted devices worldwide (98% in the US) to increase the likelihood of fracture detection prior to inappropriate therapy.
Approximately 75% of patients should get three or more days notice with the new software.

37. Communication: Instantly to Everyone
Physicians
Media
Manufacturers
Patients
Key Takeaway: The process demands that industry communicates simultaneously with all key stakeholders.
SEC: Since most manufacturers are publically traded companies, SEC influences how/when/to whom a company can communicate material information. If physicians and others were to learn of material, non-public information prior to the general public, they could be at risk of being subject to a potential insider trading situation.
FDA: Requires open disclosure in timely manner
Physicians: Need actionable information to make informed decisions regarding patient care
Patients: Deserve the best, most informed care from their physician. Increasingly, patients are involved in making their own healthcare decisions, and gather their information from many information sources.
A final factor:
Media: Internet, TV, news spreads instantly, globally
Public
Regulators

38. Device Recalls: Arguments Against Full Transparency
Physicians are not trained or knowledgeable enough about device malfunctions to make an informed decision
If the industry standard was full transparency, the information overload to the physician would be overwhelming and ignored
Devices save lives even if they are not perfect
Current devices have lower malfunction rates than ever
Hysteria around “recalls” cause many device to be explanted that should not be explanted
Cost
Risk of re-operation
Current “Recall” nomenclature is misleading
Depends on your definition of full “transparency”
Bad press makes patients reluctant to give consent for a life-saving therapy
Medico-legal implications

39. Risk of Telling Docs Too Much?
Do Physicians Know How To React to a Recall?
Maximal risk of the device not functioning in a life saving situation of recently recalled devices is maximally 0.65% against a >2% risk of infection, 1% risk of damaging an existing lead at a cost greater than $20,000 per re-implant. This would put the cost for two USA Guidant re-implants at a staggering $181,250,000.
One is re-implanting a device with an unknown error rate of between 0-1%
Patients have an even poorer understanding of the above problem.
Physicians have overreacted to recent device recall creating huge cost and risk to patients
Medico-legal issues obviously add to a disproportionate number of recalled devices being taken out and replaced.
Naccarelli, GV. Subanalysis to Guidant Independent Panel

40. Lawsuits Filed within Hours of Field Action Announcement
Fidelis
Transparency of information is essential so all parties have access to the same information at the same time.
Each stakeholder will react to the information differently despite simultaneous receipt of identical information.

41. Patient Impact of a Change in Terminology from Device “Recall” to Device “Advisory”
Patient Perception
Key Takeaway: The FDA classifies device recalls into three classes depending on the level of severity.
Murray, CM, et. al. “Device “Recall” Terminology: Results of a Patient Study.” Presented at 2008 HRS.

42. Definition Problems: All FDA “Recalls” Are Not the Same
Class I
Reasonable probability that if a device is malfunctioning there will be a serious adverse health consequence or death
Does not necessarily require removal of the device
Sponsor needs to disclose the device malfunction to patients and doctors and provide additional instructions for safe use of the device
Class II Recall
The malfunctioning product may cause temporary or medically reversible adverse health consequences; however, the probability of serious adverse health consequences is remote

43. Reasons for Device Replacement
Patient Perception
Key Takeaway: 17.6% of devices in the Costea study were explanted due to patient request.
Key Points:
Patient Request is the third-largest reason for device replacement
Costea A, J Cardiovasc Electrophysiol, 19: , 2008
Murray, CM, et. al. “Device “Recall” Terminology: Results of a Patient Study.” Presented at 2008 HRS.

44. Significantly More Patients Want a “Recall” Device Removed than an “Advisory” Device
Patient Perception
Patients who want the device removed no matter what:
2.5% if there was a “safety advisory”
5.0% if there was a “recall”
p=0.01, Chi-square and Fisher’s exact tests
Key Takeaway: Twice as many patients want a “recall” device removed than an “advisory” device, which is a statistically significant reduction.
Key Points:
Two questions were asked
Similar phrasing except “safety advisory” was replaced by “recall”
Three options: unconditional explant, listening to their doctor’s advice, or not replacing the device unless it failed
The number of patients who wanted an unconditional explant doubled when “safety advisory” was changed to “recall”
A change in the terminology could potentially reduce the number of complications by half
Murray, CM, et. al. “Device “Recall” Terminology: Results of a Patient Study.” Presented at 2008 HRS.

45. Definition Issues: Are All Device Malfunctions the Same?
Device Failure: The inability of the device to provide the therapy that is intended for the survival or avoidance of major medical morbidities.
Device Malfunction: A deviation from the intended function or response to a clinical event that the device is intended to provide. Malfunctions in the extreme may be device failures as defined above, or may be of lesser clinical significance but still requiring mitigation.
Random: A defect unique to a specific component that causes non-repetitive malfunctions or failures. This may be due to manufacturing error during construction of a single device or a single defective component.
Systematic: Repetitive malfunctions or failures due to a design flaw or inherent component defect.
Manifest vs potential life-threatening events: “Manifest” refers to the occurrence of one or more actual fatal or near-miss events as a result of device failure or malfunction. “Potential” refers to a flaw or defect that creates a realistic potential for a fatal or near-miss event in the future, if not mitigated or replaced.
Guidant Independent Panel Report

46. Industry’s Tracking of Device Performance
System Longevity
Study
75,000 Patients
Data
Product Performance
Report
70 Million
Patient Years
Medtronic CareLink
Remote Monitoring
250,000 Patients
Enrolled
Key Takeaway: Together, the System Longevity Study, Product Performance Reports and Remote Monitoring represent a proactive commitment by Medtronic to monitoring and reporting on the performance of implanted product.
Key Points:
The System Longevity Study includes data from 75,000 patients and is ongoing in 30 centers worldwide.
Product Performance Reports are a published summary of internal analysis data plus System Longevity Study data. Internal analysis comes from Returned Product and Continuous Improvement Quality measures such as iteration of findings from devices that do not ship because they fail internal quality tests.
The CareLink Remote Monitoring database represents data from 250,000 patients enrolled and has had over 1 million transmissions.

47. Performance Monitoring
Returned Products Analysis
System Longevity Study
Passive assessment
Hard feedback on specific returns
25 years, 75,000 patients
Prospective view and trending
Product Complaints and Physician Input
Post Market Studies
Registries
RV Optimize (3830 Select Secure)
Conditions of Approval (4195 Starfix)
Key Takeaway: When it comes to Medtronic’s surveillence activities, Patient Safety always comes first.
Key Points:
Every complaint is evaluated by a quality engineer to determine whether an investigation is required.
If the issue is known: The event is checked against our previous investigation. If the product is not behaving as we expect, we will react to an unusual observation and initiate an investigation.
If the issue is new: An investigation is initiated and A risk assessment is performed to quantify potential patient impact.
We receive information about issues on our products from physicians, patients, journals, and from our own internal organization.
Technical Services calls
MAUDE Industry database
Physician studies and registries

48. Device Recalls/Transparency: Final Thoughts
Not all devices need to be explanted STAT or maybe at all
Monitor risk/benefit e.g. risk of infection, compatibility of new device with other hardware, coexisting anticoagulation, age, co-morbidities
Is the patient dependent on the device or not
When is the EOL (if only 1 year to go, elective replacement reasonable)
Monitor the situation
The problem may be worse or better than you initially thought as more information comes available
Increase device monitoring of patients
Although we expect a 0% failure tolerance, what is realistic (<1%)
HRS, FDA and industry have set new standards for reporting etc.
Future transparency will depend on massive physician education campaign and redefinition of device malfunctions