1. Experience The reveal linq™ advantage
Insertable Cardiac Monitoring System
with TruRhythm™ Detection

2. Reveal™ Insertable cardiac monitor leading innovation for more than 20 years
2000
Reveal Plus
2007 Reveal DX
2009 Reveal XT
2011
FullView Software
World’s first ICM
14-month battery
World’s second ICM
MR Conditional
3-year battery
Added to the Medtronic CareLink™ Network
AF detection algorithm
Cardiac Compass™ diagnostics
Improved data viewing and collection
Improved noise discrimination
Improved AF detection
2014
Reveal LINQ™
World’s smallest ICM
Simplified insertion procedure
Improved AF detection
Simplified reporting and patient management
2017
TruRhythm™ Detection
inside the Reveal LINQ ICM
World’s most accurate ICM
New smart filtering & self-learning detection algorithms
Improved reporting
Reveal LINQ™ Insertable Cardiac Monitoring System

3. The Reveal linq advantage powerful cardiac monitoring
Indications for use
The Reveal LINQ Insertable Cardiac Monitor (ICM) is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:
Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
Patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain, that may suggest a cardiac arrhythmia
The device has not been tested specifically for pediatric use.
Reveal LINQ™ Insertable Cardiac Monitoring System

4. 3 in 4 The Reveal linq advantage powerful cardiac monitoring
ICMs are underutilized
ICMs are recommended by clinical guidelines1,2 ─ yet significantly underutilized
Up to
3 in 4
Patients who met appropriate criteria for ICM implantation
did not receive one3
Kirchhof P, et al ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. EurHeart J. 2016; 37:
Shen WK, et al ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope. J Am Coll Cardiol DOI: /j.jacc
Vitale E, Ungar A, Maggi R, et al. Discrepancy between clinical practice and standardized indications for an implantable loop recorder in patients with unexplained syncope. Europace. October 2010; 12(10): Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. June 26, 2014;370(26):
Reveal LINQ™ Insertable Cardiac Monitoring System

5. The Reveal linq advantage an advanced monitoring solution
Reveal LINQ ™ ICM
MyCareLink™ Patient Monitor
CareLink™ Network
and Reports
Solution Enablers
Insertion Tools
Minimally invasive procedure
Patient Assistant
One-button symptom marking
Reveal LINQ™ Insertable Cardiac Monitoring System

6. The Reveal linq advantage revolutionizing cardiac monitoring
The world’s smallest, most accurate ICM
One-third the size of a AAA battery (1.2 cc)
Minimally invasive, simplified insertion procedure4
Up to a 3-year longevity for long-term monitoring5
Reveal LINQ Usability Study. Medtronic data on file
Reference the Reveal LINQ ICM Clinician Manual for usage parameters.
MR Conditional at 1.5 and 3.0 Tesla
Reveal LINQ™ Insertable Cardiac Monitoring System

7. The Reveal linq advantage optimized longevity
Device longevity that optimizes diagnostic yield
Up to 3 years5 of continuous, long-term cardiac monitoring for infrequent symptoms and ongoing arrhythmia management.
Reference the Reveal LINQ ICM Clinician Manual for usage parameters.
Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. June 26, 2014;370(26):
Furukawa T, Maggi R, Bertolone C, Fontana D, Brignole M. Additional diagnostic value of very prolonged observation by implantable loop recorder in patients with unexplained syncope. J Cardiovasc Electrophysiol. January 2012;23(1):67-71. 7
Reveal LINQ™ Insertable Cardiac Monitoring System

8. 97% The Reveal linq advantage simple insertion procedure
Best Location: 45 degrees to sternum over 4th intercostal space, 2 cm from left edge of sternum
97%
of physicians found the insertion tool simple and intuitive4
4. Reveal LINQ Usability Study. Medtronic data on file
Reveal LINQ™ Insertable Cardiac Monitoring System

9. The Reveal linq advantage smart ecg data storage
ECG data storage: 59 minutes total
Patient-activated: up to 30 minutes
4 7.5 minutes each
3 10 minutes each
2 15 minutes each
Patient-activated
9 min prior
14 min prior
1 min
6.5 min prior
Patient Assistant
Reveal LINQ™ Insertable Cardiac Monitoring System

10. The Reveal linq advantage smart ecg data storage
ECG data storage: 59 minutes total
Automatically detected: 27 minutes
End of episode
Pause, Brady, Tachy
30 sec
27 sec
Start of episode
AT/AF
Automatic detection
2 minutes of longest AF episode stored since last interrogation in addition to the 27 minutes of automatically detected episodes.
Reveal LINQ™ Insertable Cardiac Monitoring System

11. The Reveal linq advantage powerful cardiac monitoring
Reveal LINQ™ System with TruRhythm™ Detection
The world’s smallest, most accurate ICM delivers actionable data to diagnose and treat even the most difficult-to-detect arrhythmias 11
Reveal LINQ™ Insertable Cardiac Monitoring System

12. Unmatched accuracy

13. The Reveal linq advantage unmatched accuracy
Driving accuracy evolution
Dedicated to advancing accuracy with every device generation
Reveal LINQ™ Insertable Cardiac Monitoring System

14. Unmatched ACCURACY TRURHYTHM™ dETECTION
New intelligence inside
Our newest detection algorithms streamline episode review without sacrificing sensitivity
Smart filtering
NEW second sensing filter analyzes rhythms for possible undersensing in Brady and Pause
Self-learning
NEW AF algorithm learns and adapts to patients with sinus arrhythmia
Reveal LINQ™ Insertable Cardiac Monitoring System

15. Unmatched ACCURACY atrial fibrillation
Advanced AF detection*
Superior AF detection accuracy that streamlines episode review
Reveal LINQ ICM8
Confirm™ ICM9
Confirm-AF9
AF False Positives %†
BioMonitor 2-AF10
TruRhythm Detection Algorithms. Medtronic data on file
Nölker G, Mayer J, Boldt LH, et al. Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. J Cardiovasc Electrophysiol. December 2016;27(12):
Biotronik BioMonitor 2 Clinical Manual
Sanders P, Pürerfellner H, Pokushalov E, et al. Performance of a new atrial fibrillation detection algorithm in a miniaturized ICM: Results from the Reveal LINQ Usability Study. Heart Rhythm. July 2016;13(7):
* In known AF patients.
Reveal LINQ11
Reveal LINQ with TruRhythm Detection8
† % of False Positives = (1-Episode PPV). Episode PPV may vary (gross, patient average). 15
Reveal LINQ™ Insertable Cardiac Monitoring System

16. Unmatched ACCURACY actionable reporting
Cardiac Compass™ Report
Daily AF Burden
Ventricular Rate During AF
Day/Night HR
Patient Activity
Heart Rate Variability
All patient and clinical data are fictitious and for demonstration purposes only.
Reveal LINQ™ Insertable Cardiac Monitoring System

17. superior evidence

18. The Reveal linq advantage superior evidence
MOST STUDIED
Evidence portfolio that includes 500+ published clinical articles and abstracts12
MOST
VALIDATED
Clinical validation across Cryptogenic Stroke, Syncope, and Atrial Fibrillation patients6,11,13, 14
1. Kirchhof P, et al ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. EurHeart J. 2016; 37:
2. Shen WK, et al ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope. J Am Coll Cardiol DOI: /j.jacc Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. June 26, 2014;370(26):
6. Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. June 26, 2014;370(26):
11. Sanders P, Pürerfellner H, Pokushalov E, et al. Performance of a new atrial fibrillation detection algorithm in a miniaturized ICM: Results from the Reveal LINQ Usability Study. Heart Rhythm. July 2016;13(7):
12. Medtronic Reveal Publications. Medtronic data on file. 2016
13. Edvardsson N, Frykman V, van Mechelen R, et al. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry. Europace. February 2011;13(2):
14. Reiffel JA, Verma A, Kowey PR, et al. High Incidence of Previously Unknown (“Silent”) Atrial Fibrillation in Patients at High Risk for Atrial Fibrillation and Stroke: Primary Results from the REVEAL AF Study. Abstract presented at Heart Rhythm Society Annual Scientific Sessions
MOST
UTILIZED
Data leveraged by clinical societies to develop treatment guidelines across conditions1,2
Reveal LINQ™ Insertable Cardiac Monitoring System

19. Superior evidence cryptogenic stroke
Each year, at least
200,000 cryptogenic strokes
occur in the United States15
Cryptogenic stroke accounts for approximately 1/3 of ischemic strokes in the majority of modern stroke registries16-21
American Heart Association. Heart Disease and Stroke Statistics, 2015 Update. Available at: Accessed April 12, 2015.
Sacco RL, Ellenberg JH, Mohr JP, et al. Infarcts of undetermined cause: the NINCDS Stroke Data Bank. Ann Neurol. April 1989;25(4):
Petty GW, Brown RD Jr, Whisnant JP, Sicks JD, O’Fallon WM, Wiebers DO. Ischemic stroke subtypes: a population-based study of incidence and risk factors. Stroke. December 1999;30(12):
Kolominsky-Rabas PL, Weber M, Gefeller O, Neundoerfer B, Heuschmann PU. Epidemiology of ischemic stroke subtypes according to TOAST criteria: incidence, recurrence, and long-term survival in ischemic stroke subtypes: a population-based study. Stroke. December 1, 2001;32(12):
Schulz UG, Rothwell PM. Differences in vascular risk factors between etiological subtypes of ischemic stroke: importance of population-based studies. Stroke. August 2003;34(8):
Schneider AT, Kissela B, Woo D, et al. Ischemic stroke subtypes: a population-based study of incidence rates among blacks and whites. Stroke. July 2004;35(7):
Lee BI, Nam HS, Heo JH, Kim DI, Yonsei Stroke Team. Yonsei Stroke Registry. Analysis of 1,000 patients with acute cerebral infarctions. Cerebrovasc Dis. 2001;12(3):
Reveal LINQ™ Insertable Cardiac Monitoring System

20. 5X 2X 67% Superior evidence cryptogenic stroke
AF detection and treatment matters 5X
increase in ischemic stroke risk for AF patients22 2X
more likely for AF-related ischemic stroke to be fatal than non-AF stroke23
67%
decrease in AF stroke risk with oral anticoagulants24
Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation: a major contributor to stroke in the elderly. The Framingham Study. Arch Intern Med. September 1987;147(9):
Lin HJ, Kelly-Hayes M, Beiser AS, et al. Stroke Severity in Atrial Fibrillation: The Framingham Study. Stroke. 1996; 27:
Frankel D, Parker S, Rosenfeld L, et al. HRS/NSA 2014 survey of atrial fibrillation and stroke: Gaps in knowledge and perspective, opportunities for improvement. Heart Rhythm. August 2015; 12(8):e105-e113.
Stroke Prevention in Atrial Fibrillation Study. Final results. Circulation. August 1991;84(2): 20
Reveal LINQ™ Insertable Cardiac Monitoring System

21. 84 DAYS 88% Superior evidence cryptogenic stroke CRYSTAL AF Study6
median time to AF detection in cryptogenic stroke patients6
The CRYSTAL-AF Study found that continuous monitoring with Reveal ICM is superior to standard medical care for the detection of AF in cryptogenic stroke patients
Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. June 26, 2014;370(26):
88%
of patients who had AF would have been missed if only monitored for 30 days6
Reveal LINQ™ Insertable Cardiac Monitoring System

22. Superior evidence cryptogenic stroke
2016 ESC guidelines for the management of AF
Long-term insertable cardiac monitoring recommended for cryptogenic stroke patients to document silent AF1
Kirchhof P, et al ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. EurHeart J. 2016; 37: 22
Reveal LINQ™ Insertable Cardiac Monitoring System

23. 2X >10% Superior evidence syncope
237,000 HOSPITALIZATIONS25
SYNCOPE AVERAGES 740,000 ER VISITS PER YEAR*25
HALF OF PATIENTS ADMITTED TO THE HOSPITAL LEAVE WITHOUT A DIAGNOSIS26
*Data obtained from National Hospital Ambulatory Medical Care Survey between to 2000.
Sun BC, Emond JA, Camargo CA Jr. Inconsistent electrocardiographic testing for syncope in United States emergency departments. Am J Cardiol. May 15, 2004;93(10):
Mendu ML, McAvay G, Lampert R, Stoehr J, Tinetti ME. Yield of diagnostic tests in evaluating syncopal episodes in older patients. Arch Intern Med. July 27, 2009;169(14):
Soteriades ES, Evans JC, Larson MG, et al. Incidence and prognosis of syncope.N Engl J Med. September 19, 2002;347(12): 2X
increased risk of death27
>10%
mortality rate at six months27
SYNCOPE WITH A CARDIAC CAUSE INCREASES MORTALITY RATES
Reveal LINQ™ Insertable Cardiac Monitoring System

24. 3 13 1 in 4 Superior evidence syncope Patients want answers
specialists visited on average13
Superior evidence syncope
Patients want answers
Patients endure ongoing diagnostic testing and still come away with no answers13 13
inconclusive tests13
Physician specialties consulted13
Diagnostic tests performed13
Edvardsson N, Frykman V, van Mechelen R, et al. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry. Europace. February 2011;13(2):
1 in 4
undergo more than 20 tests13
Reveal LINQ™ Insertable Cardiac Monitoring System

25. Superior evidence syncope
PICTURE Study13
570 patients enrolled
Edvardsson N, Frykman V, van Mechelen R, et al. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry. Europace. February 2011;13(2):
100% OF THESE PATIENTS RECEIVED A DIFFERENTIAL DIAGNOSIS
Reveal LINQ™ Insertable Cardiac Monitoring System

26. Superior evidence syncope
2017 ACC/AHA/HRS guidelines for the management of syncope2
Insertable cardiac monitoring recommended for syncope patients based on frequency and nature of events
Shen WK, et al ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope. J Am Coll Cardiol DOI: /j.jacc 26
Reveal LINQ™ Insertable Cardiac Monitoring System

27. ~90% 1/5th 61% STROKE Superior evidence atrial fibrillation29 28
23. Lin HJ, Kelly-Hayes M, Beiser AS, et al. Stroke Severity in Atrial Fibrillation: The Framingham Study. Stroke. 1996; 27:
World Heart Federation statistics.
Benjamin EJ, Blaha MJ, Chiuve SE, et al. Heart Disease and Stroke Statistics — 2017 Update. A Report From the American Heart Association. Circulation. March 7, 2017;135(10):e146-e603.
31. Strickberger, SA, Ip J, Saksena S, et al. Relationship between atrial tachyarrhythmias and symptoms. Heart Rhythm. February 2005;2(2):
~90%
of AF episodes may be asymptomatic30
1/5th
of patient symptoms thought to be AF were actually due to AF30
STROKE
is the first symptom for ~20% of patients who have an AF-related stroke23
61%
of patients who had both AF and a stroke did not know they had AF before their stroke31
SYMPTOMS ARE NOT A RELIABLE INDICATIOR OF AF 27
Reveal LINQ™ Insertable Cardiac Monitoring System

28. 40% 84.5% Superior evidence atrial fibrillation REVEAL AF Study14
AF detection rate at 30 months14
AF detection increases over time for patients at high risk for AF and stroke.
Reiffel JA, Verma A, Kowey PR, et al. High Incidence of Previously Unknown (“Silent”) Atrial Fibrillation in Patients at High Risk for Atrial Fibrillation and Stroke: Primary Results from the REVEAL AF Study. Abstract presented at Heart Rhythm Society Annual Scientific Sessions
84.5%
of patients with AF would have been missed if only monitored for 30 days14
Reveal LINQ™ Insertable Cardiac Monitoring System

29. simplified monitoring

30. The Reveal linq advantage simplified monitoring
A VIRTUAL EXTENSION OF YOUR CLINICAL TEAM
Reveal LINQSM Monitoring Service
APP-BASED INSERTION WORKFLOW
Reveal LINQ Mobile Manager
MORE EFFICIENT DATA MANAGEMENT
Enhanced CareLink™ Network
Reveal LINQ™ Insertable Cardiac Monitoring System

31. Simplified monitoring Reveal LINQ Mobile manager
Powerfully simple device management
Manage device registration, activation, CareLink™ pre-enrollment and patient education – right from your tablet 31
Reveal LINQ™ Insertable Cardiac Monitoring System

32. Simplified monitoring the CareLInk network
Previous Workflow
NEW Workflow
More efficient data management
Quick Look™ update provides new timesaving for clinicians who manage Reveal LINQ patients
Fewer Downloads
Fewer downloads mean less time waiting for the CareLink Network to access the information you need
Fewer Clicks
Transmission Details opens the Quick Look view
Assess and adjudicate episodes right from the Quick Look page -- no need to navigate between episodes
Reveal LINQ™ Insertable Cardiac Monitoring System

33. Simplified monitoring the CareLInk network
Clinically actionable reports
Simple and clear reporting that provides the information you need to take action
Event Reports
Delivered based on clinician-ordered criteria
Summary Reports
Delivered every 30 days
Full Report
Delivered when you request manual transmission
Clinical and patient data are fictitious and for demonstration purposes only.
Reveal LINQ™ Insertable Cardiac Monitoring System

34. Simplified monitoring reveal linq monitoring service
Support to optimize your time
A virtual extension of your clinical team, helping you streamline patient management and cardiac data review for patients with a Reveal LINQ™ ICM.*
* Patients must be covered by insurance providers who are on contract with the service.
Patient
management and communication
ensures data transmission
Cardiac data review by certified technicians
identifies the most clinically relevant data
Clinically actionable reporting summarizes what you want to know to inform decisions
Reveal LINQ™ Insertable Cardiac Monitoring System

35. The Reveal linq advantage syncope patient impact
William’s story
Reveal LINQ ICM used to discover Atrioventricular Nodal Reentrant Tachycardia
The first time William fainted was just after he stood up to get a second cup of coffee. He was unconscious for 30 seconds while his wife feared he was dead. Another time while out for dinner, without warning his head fell forward and he lost consciousness. Over the years, William experienced an ambulance trip, multiple visits to the hospital, and appointments with various physician specialties. Multiple tests showed nothing.
Years went by without incident until he was on vacation in Paris. As he walked along a cobblestone street with his family, William collapsed. His face slammed into the cobblestone curb causing serious injury.
Back in the US, his doctor recommended the Reveal LINQ ICM. The device was inserted in February, The following August, an episode of nonsustained SVT was detected while he slept.
Today, following a successful ablation procedure, William is back to enjoying life. He works out multiple times a week and enjoys traveling with his family, playing basketball, tennis, and golf.
This story reflects one person’s experience. Not every person will receive the same results.
Reveal LINQ™ Insertable Cardiac Monitoring System

36. FPO The Reveal linq advantage cryptogenic stroke patient impact
Scott’s story
Reveal ICM used to discover AF in 22-year-old stroke patient
On his way to a soccer game, 22-year-old Scott suddenly began wobbling. His head started throbbing. What he thought was dehydration turned out to be much worse. The college student had suffered a stroke. Surgeons removed a blood clot in his brain, but a looming question remained: What caused the stroke in this seemingly healthy young man?
Scott’s doctors suspected it was the result of atrial fibrillation (AF). So Scott’s doctors turned to the Reveal LINQ ICM, which, within a few months, confirmed he had AF.
The diagnosis not only gave Scott’s doctors the information they needed to prescribe stroke- preventive blood thinners; it gave Scott the peace of mind to live life fully again.
FPO
This story reflects one person’s experience. Not every person will receive the same results.
Reveal LINQ™ Insertable Cardiac Monitoring System

37. The Reveal linq advantage Atrial Fibrillation patient impact
Debbie’s story
Reveal ICM finds AF and informs treatment plan
When Debbie started experiencing an uncomfortable heart fluttering, she tried to ignore it. When the episodes became more frequent, she could no longer deny something was wrong. That’s when she made an appointment with a cardiologist.
Debbie’s doctor suggested an insertable cardiac monitor to determine the cause of her episodes. The Reveal ICM discovered that the upper chambers of Debbie’s heart were beating very fast and irregularly.
She was referred to an EP, who used the Reveal ICM data to guide the development of a treatment plan.
Eventually, Debbie regained her old energy and enthusiasm. “I was so excited that it captured an abnormal heart rhythm. It wasn’t in my head after all,” Debbie said.
This story reflects one person’s experience. Not every person will receive the same results.
Reveal LINQ™ Insertable Cardiac Monitoring System

38. references
Kirchhof P, et al ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. EurHeart J. 2016; 37:
Shen WK, et al ACC/AHA/HRS Guideline for the Evaluation and Management of Patients With Syncope. J Am Coll Cardiol DOI: /j.jacc
Vitale E, Ungar A, Maggi R, et al. Discrepancy between clinical practice and standardized indications for an implantable loop recorder in patients with unexplained syncope. Europace. October 2010; 12(10): Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. June 26, 2014;370(26):
Reveal LINQ Usability Study. Medtronic data on file
Reference the Reveal LINQ ICM Clinician Manual for usage parameters.
Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. June 26, 2014;370(26):
Furukawa T, Maggi R, Bertolone C, Fontana D, Brignole M. Additional diagnostic value of very prolonged observation by implantable loop recorder in patients with unexplained syncope. J Cardiovasc Electrophysiol. January 2012;23(1):67-71.
TruRhythm Detection Algorithms. Medtronic data on file
Nölker G, Mayer J, Boldt LH, et al. Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. J Cardiovasc Electrophysiol. December 2016;27(12):
Biotronik BioMonitor 2 Clinical Manual
Sanders P, Pürerfellner H, Pokushalov E, et al. Performance of a new atrial fibrillation detection algorithm in a miniaturized ICM: Results from the Reveal LINQ Usability Study. Heart Rhythm. July 2016;13(7):
Medtronic Reveal Publications. Medtronic data on file
Edvardsson N, Frykman V, van Mechelen R, et al. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry. Europace. February 2011;13(2):
Reiffel JA, Verma A, Kowey PR, et al. High Incidence of Previously Unknown (“Silent”) Atrial Fibrillation in Patients at High Risk for Atrial Fibrillation and Stroke: Primary Results from the REVEAL AF Study. Abstract presented at Heart Rhythm Society Annual Scientific Sessions
American Heart Association. Heart Disease and Stroke Statistics, 2015 Update. Available at: Accessed April 12, 2015.
Sacco RL, Ellenberg JH, Mohr JP, et al. Infarcts of undetermined cause: the NINCDS Stroke Data Bank. Ann Neurol. April 1989;25(4):
Petty GW, Brown RD Jr, Whisnant JP, Sicks JD, O’Fallon WM, Wiebers DO. Ischemic stroke subtypes: a population-based study of incidence and risk factors. Stroke. December 1999;30(12):
Kolominsky-Rabas PL, Weber M, Gefeller O, Neundoerfer B, Heuschmann PU. Epidemiology of ischemic stroke subtypes according to TOAST criteria: incidence, recurrence, and long-term survival in ischemic stroke subtypes: a population-based study. Stroke. December 1, 2001;32(12):
Schulz UG, Rothwell PM. Differences in vascular risk factors between etiological subtypes of ischemic stroke: importance of population-based studies. Stroke. August 2003;34(8):
Reveal LINQ™ Insertable Cardiac Monitoring System

39. references
Schneider AT, Kissela B, Woo D, et al. Ischemic stroke subtypes: a population-based study of incidence rates among blacks and whites. Stroke. July 2004;35(7):
Lee BI, Nam HS, Heo JH, Kim DI, Yonsei Stroke Team. Yonsei Stroke Registry. Analysis of 1,000 patients with acute cerebral infarctions. Cerebrovasc Dis. 2001;12(3):
 Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation: a major contributor to stroke in the elderly. The Framingham Study. Arch Intern Med. September 1987;147(9):
Lin HJ, Kelly-Hayes M, Beiser AS, et al. Stroke Severity in Atrial Fibrillation: The Framingham Study. Stroke. 1996; 27:
Stroke Prevention in Atrial Fibrillation Study. Final results. Circulation. August 1991;84(2):
Sun BC, Emond JA, Camargo CA Jr. Inconsistent electrocardiographic testing for syncope in United States emergency departments. Am J Cardiol. May 15, 2004;93(10):
Mendu ML, McAvay G, Lampert R, Stoehr J, Tinetti ME. Yield of diagnostic tests in evaluating syncopal episodes in older patients. Arch Intern Med. July 27, 2009;169(14):
Soteriades ES, Evans JC, Larson MG, et al. Incidence and prognosis of syncope.N Engl J Med. September 19, 2002;347(12):
World Heart Federation statistics.
Benjamin EJ, Blaha MJ, Chiuve SE, et al. Heart Disease and Stroke Statistics — 2017 Update. A Report From the American Heart Association. Circulation. March 7, 2017;135(10):e146-e603.
Strickberger, SA, Ip J, Saksena S, et al. Relationship between atrial tachyarrhythmias and symptoms. Heart Rhythm. February 2005;2(2):
Frankel D, Parker S, Rosenfeld L, et al. HRS/NSA 2014 survey of atrial fibrillation and stroke: Gaps in knowledge and perspective, opportunities for improvement. Heart Rhythm. August 2015; 12(8):e105-e113.
Reveal LINQ™ Insertable Cardiac Monitoring System

40. Indications, Safety, and Warnings
If you are located in the United States, please refer to the brief statement below to review applicable indications, safety, and warning information. See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at and/or consult the Medtronic website at medtronic.com.
If you are located outside the United States, see the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.com.
Consult instructions for use at this website. Manuals can be viewed using a current version of any major Internet browser. For best results, use Adobe Acrobat Reader® with the browser.
Important Reminder: This information is intended only for users in markets where Medtronic products and therapies are approved or available for use as indicated within the respective product manuals. Content on specific Medtronic products and therapies is not intended for users in markets that do not have authorization for use.
The Medtronic MyCareLink Patient Monitor and the Medtronic CareLink Network are indicated for use in the transfer of patient data from Medtronic implantable cardiac devices. These products are not a substitute for appropriate medical attention in the event of an emergency. Data availability and alert notifications are subject to Internet connectivity and access, and service availability. The MyCareLink Patient Monitor must be on and in range of the device. Alert notifications are not intended to be used as the sole basis for making decisions about patient medical care.
Reveal LINQ™ Insertable Cardiac Monitor, Reveal LINQ™ Mobile Manager System and Patient Assistant
Indications: The Reveal LINQ insertable cardiac monitor (ICM) is an implantable patient-activated and automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:
Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
Patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain, that may suggest a cardiac arrhythmia
The device has not been tested specifically for pediatric use.
Reveal LINQ Mobile Manager System The Reveal LINQ Mobile Manager app is intended for programming and interrogating the Reveal LINQ ICM LNQ11. The Medtronic patient connector is a portable electronic device using low frequency inductive telemetry to communicate with the Reveal LINQ ICM. The patient connector uses Bluetooth® technology to transmit implantable heart device data to the Reveal LINQ Mobile Manager app for further processing. The patient connector is intended to be used by healthcare personnel only in a clinical or hospital environment.
Reveal LINQ™ Insertable Cardiac Monitoring System

41. Indications, Safety, and Warnings
Patient Assistant The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management feature in the Reveal™ insertable cardiac monitor to initiate recording of cardiac event data in the implanted device memory.
Contraindications: There are no known contraindications for the implant of the Reveal LINQ ICM or for the Reveal LINQ Mobile Manager system. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.
Reveal LINQ Insertable Cardiac Monitor Warnings/Precautions Patients with the Reveal LINQ ICM should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the Medical procedure and EMI precautions manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the Reveal LINQ MRI Technical Manual.
Reveal LINQ Mobile Manager System Before inserting the Reveal LINQ ICM, verify that the patient connector and mobile device are fully charged. The patient connector and mobile device may run out of power during the insertion procedure if they are not fully charged.You will not be able to program or interrogate the patient’s Reveal LINQ ICM until the patient connector and the mobile device have power.
Only use the patient connector to communicate with the intended implanted device. Do not use the patient connector to communicate with other implanted devices. Using the patient connector to communicate with other implanted devices can interfere with those devices, potentially affecting the other implanted device’s functionality or therapy delivery.
Use of wireless devices — The patient connector incorporates radiofrequency (RF) communications components which may affect other devices and equipment in the medical environment. The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization. RF interference may affect device performance. Electromagnetic Compliance (EMC) testing shows that the patient connector provides reasonable protection against harmful interference and provides EMC immunity in a typical medical installation. The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization. However, there is no guarantee that interference will not occur in a particular installation. If the patient connector does cause harmful interference to other devices or is negatively impacted by other devices, correct the interference by one or more of the following measures: reorient or relocate the patient connector and other devices; increase the separation between the patient connector and other devices by at least two meters (approximately 6 feet); and/or turn off any interfering equipment.
Radiofrequency (RF) interference — Portable and mobile RF communications equipment can interfere with the operation of the patient connector. There is no guarantee that it will not receive interference or that any particular transmission from this system will be free from interference. To avoid interference, do not use the patient connector and mobile device within 2 m (6 feet) of other wireless communications equipment. Using the patient connector near these devices could interfere with communication between the Reveal LINQ ICM and the patient connector.
Reveal LINQ™ Insertable Cardiac Monitoring System

42. Indications, Safety, and Warnings
Security — Maintain adequate physical security of the patient connector to prevent unauthorized use that could lead to harm to patients. Bluetooth communication in the patient connector is encrypted for security. Medtronic inductive telemetry uses short-range communication to protect patient information. If the patient connector should fail, there is no risk of patient harm.
Environmental precautions — To ensure safe and effective operation, use the device with care to avoid damage to the patient connector from environmental factors that may impair its function. Care is exercised in design and manufacturing to minimize damage to devices under normal use. However, electronic devices are susceptible to many environmental stresses. Specifically, the patient connector may be affected by electrostatic discharge (ESD). In an environment likely to cause ESD, such as a carpeted floor, discharge any charge collected on your body before touching the device.
Patient Assistant Operation of the Patient Assistant near sources of electromagnetic interference, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device.
Potential Complications: Potential complications of the Reveal LINQ device include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.
Medtronic MyCareLink™ Patient Monitor, Medtronic CareLink™ Network and CareLink™ Mobile Application
Intended Use: The Medtronic MyCareLink patient monitor and CareLink network are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. The CareLink mobile application is intended to provide current CareLink network customers access to CareLink network data via a mobile device for their convenience. The CareLink mobile application is not replacing the full workstation, but can be used to review patient data when a physician does not have access to a workstation. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician. CareLink network availability and mobile device accessibility may be unavailable at times due to maintenance or updates, or due to coverage being unavailable in your area. Mobile device access to the Internet is required and subject to coverage availability. Standard text message rates apply.
Contraindications: There are no known contraindications.
Warnings and Precautions: The MyCareLink patient monitor must only be used for interrogating compatible Medtronic implantable devices.
See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at and/or consult the Medtronic website at medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Reveal LINQ™ Insertable Cardiac Monitoring System

43. Medtronic and the Medtronic logo are trademarks of Medtronic. ™
Medtronic and the Medtronic logo are trademarks of Medtronic.™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
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07/2017
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Reveal LINQ™ Insertable Cardiac Monitoring System