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The Facts About Effectively Managing Intractable Cancer Pain © Medtronic, Inc. 2009.

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Presentation on theme: "The Facts About Effectively Managing Intractable Cancer Pain © Medtronic, Inc. 2009."— Presentation transcript:

1 The Facts About Effectively Managing Intractable Cancer Pain © Medtronic, Inc. 2009

2 2 Sources of Pain in Cancer Patients Cancer pain comprises: Acute pain Chronic pain Tumor-specific pain Treatment-related pain Carr D, Goudas L, Lawrence D, et al. Management of cancer symptoms: pain, depression, and fatigue. Evidence report/technology assessment No. 61 (prepared by the New England Medical Center Evidence based Practice Center under contract No ). AHRQ Publication No. 02-E032. Rockville, MD: Agency for Healthcare Research and Quality. July Downloaded at on 4/22/ Accessed 03/23/2009

3 3 © Medtronic, Inc Existence of pain due to cancer Base: all screened – (individual base sizes shown on chart) S4. Have you suffered any pain due to your cancer? More than two thirds of cancer patients report pain which they attribute to their cancer n=4947 More than 50% of patients with the following types of cancer currently suffer from pain: § Lung § Pancreatic § Brain Tumour § Bone/Muscle § Blood Borne § Non-Hodgkins § Head/Neck § Leukaemia From S5 - Patients currently suffering from pain European Pain in Cancer (EPIC) Global Results Presentation, July 2007

4 4 © Medtronic, Inc Where We Are Today in Managing Cancer Pain? Minorities, women, and the elderly are particularly at risk for cancer-related pain. 1 One survey found that while health care providers believe they are doing a good job at managing pain and its symptoms, families do not. 2 Cancer pain still pervasive in adults and children. 3 Cancer pain is undertreated in all settings where patients with cancer are managed Carr D, Goudas L, Lawrence D, et al. Management of cancer symptoms: pain, depression, and fatigue. Evidence report/technology assessment No. 61 (prepared by the New England Medical Center Evidence based Practice Center under contract No ). AHRQ Publication No. 02-E032. Rockville, MD:Agency for Healthcare Research and Quality. July Downloaded at on 4/22/ Accessed 03/23/ Tolle SW. Family reports of pain in dying hospitalized patients: a structured telephone survey. West J Med. 2000;172: Guideline for the Management of Cancer Pain in Adults and Children p x.

5 5 © Medtronic, Inc You Are The Patient’s Advocate Patients with cancer are often reluctant to report the extent of their pain 1 –Fear that reporting pain will take physician time away from their treatment –Concern about addiction –Beliefs that “good” patients do not complain about pain –Concern about side effects with escalating doses Result = under-treatment of pain 1. Ward S, Goldberg N, Miller-McCauley V, et al. Patient-related barriers to management of cancer pain. Pain. 1993;52:

6 6 © Medtronic, Inc The Effects of Pain A majority of patients experience pain at some point during their course of cancer treatment. 1 Cancer pain impairs quality of life and functionality. 1 The cost of inadequate pain control and related side effects (of pain medications) is high, both in terms of impaired function and quality of life. 2-4 Pain interferes with all activities of daily living Carr D, Goudas L, Lawrence D, et al. Management of cancer symptoms: pain, depression, and fatigue. Evidence report/technology assessment No. 61 (prepared by the New England Medical Center Evidence based Practice Center under contract No ). AHRQ Publication No. 02-E032. Rockville, MD: Agency for Healthcare Research and Quality. July Downloaded at on 4/22/ Accessed 03/23/ Smith TJ, Staats PS, Deer T, Stearns LJ, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: Impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19): Cleeland, CS. Undertreatment of cancer pain in elderly patients. JAMA 1998;279(23): Stearns L, Boortz-Marx R, Du Pen S, Friehs G, et al. Intrathecal drug delivery for the management of cancer pain: a multidisciplinary consensus of best clinical practices. J Support Oncol. 2005;3(6): Mystakidou K, Tsilika E, Parpa E, et al.: Psychological distress of patients with advanced cancer: influence and contribution of pain severity and pain interference. Cancer Nurs 29 (5): 400-5, 2006 Sep-Oct.

7 7 © Medtronic, Inc Pain as the “Fifth Vital Sign” The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) issued a comprehensive description of patients’ rights and standards of care for pain management. Recommendation: make pain assessment/management priority in daily practice Consider pain intensity the 5 th vital sign: measure along with temperature, pulse, respiration, and blood pressure Patients’ rights: full pain workup when pain is not easily characterized or treated JCAHO,

8 8 © Medtronic, Inc Start with a Comprehensive Pain Assessment The National Cancer Institute recommends that the clinician help the patient describe pain 1 : Location Changes in pattern Intensity or severity Aggravating and relieving factors Cognitive response to pain Goals for pain control These are essential to the initial assessment: 1 Detailed history 1 Physical examination 1 Psychosocial assessment 2 Diagnostic evaluation 1 1. National Cancer Institute Accessed May 12, Otis-Green S, Sherman R, Perez M, et al.: An integrated psychosocial-spiritual model for cancer pain management. Cancer Pract 10(Suppl 1): S58-65, 2002 May-Jun.

9 9 © Medtronic, Inc Assessment Goals Characterize the pathophysiology of pain Determine intensity of pain Determine impact on patient’s ability to function 1. National Cancer Institute Accessed May 12, 2009

10 10 © Medtronic, Inc Cancer Pain Therapy: The Oncologist’s Perspective Systemic pharmacologic therapy Collaboration with pain medicine and palliative care specialists Good pain management facilitates good cancer management Levy MH. Pain control in patients with cancer. Oncology. 1999;13(5 suppl 2):9-14.

11 11 © Medtronic, Inc Multidisciplinary Approach to Chronic Pain Management Pain specialists Psychologists Nurses Social workers Rehabilitation specialists Physiological factors Social factors Psychological factors Complex Problem Multidisciplinary Solution

12 12 © Medtronic, Inc Cancer Pain Management Strategies Pharmacologic strategies –Nonopioid analgesics –Acetaminophen –Nonsteroidal anti-inflammatory drugs –Opioid analgesics –Coanalgesics (adjuvant analgesics) Physical strategies –Massage –Exercise –Transcutaneous electrical nerve stimulation (TENS) –Acupuncture Psychological strategies –Hypnosis or relaxation with imagery –Cognitive-behavioral methods Nerve blocks Radiation therapy Chemotherapy 1. Guideline for the Management of Cancer Pain in Adults and Children p

13 13 © Medtronic, Inc Opioid Analgesics for the Treatment of Cancer Pain Used most often in the management of severe pain because: 1 –Effectiveness –Ease of titration –Favorable risk-to-benefit ratio Routes of administration 2 –Oral –Transdermal –Parenteral: Intravenous or subcutaneous –Intraspinal: Epidural or intrathecal Consider when other routes of administration cannot control pain or when side effects limit further dose escalation 1.Guideline for the Management of Cancer Pain in Adults and Children p 53 2.Ibid., p 64.

14 14 © Medtronic, Inc Advanced Strategies for Intractable Cancer Pain Management Jacox A, et al. AHCPR, Portenoy R. Oncology 1999;S2: % Adequate Pain Control 10-20% Invasive Therapy Needed

15 15 © Medtronic, Inc Spinal Anatomy Spinal Cord Intrathecal Space (Subarachnoid Space) Epidural Space Pia Mater Dura Arachnoid Membrane Nerve Root

16 16 © Medtronic, Inc Epidural vs. Intrathecal Space IntrathecalSpace(SubarachnoidSpace) EpiduralSpace

17 17 © Medtronic, Inc Physiology of Spinal Opioids Nociceptors carry a “pain” signal to the dorsal horn. In the dorsal horn neurons release substance P. Substance P triggers ascending neurons that carry this signal to the brain. Opioids inhibit the release of substance P, blocking the pain transmission. Perceived pain is reduced. Pain Signal Initiated Pain Perceived

18 18 © Medtronic, Inc Epidural vs. Intrathecal Opioids 1. Levy, R. Implanted drug delivery systems for control of chronic pain. Chapter 19 of Neurosurgical Management of Pain. New York, NY: Springer-Verlag;1997.

19 19 © Medtronic, Inc What is successful pain management? Success = Pain relief – Unmanageable side effects

20 20 © Medtronic, Inc Side Effects of Cancer Pain Medications Fatigue: more prevalent than pain in patients with metastatic cancer Depressed level of consciousness, sedation: dose-limiting problems, may be treated with methylphenidate (Ritalin*) Constipation: managed with laxatives Nausea: managed with antiemetics Delirium, confusion: relatively rare Respiratory depression: very unusual Abrahm JL. A Physician’s Guide to Pain and Symptom Management in Cancer Patients *Ritalin is a registered trademark of Novartis Pharmaceuticals Corporation.

21 21 © Medtronic, Inc Approximate Equivalent Daily Doses of Morphine Administered by Various Routes Lamer TJ: Mayo Clin Proc.1994 May;69(5): Review. Route of AdministrationRelative Potency (mg)* Oral Intravenous Epidural Intrathecal *Relative approximations based on clinical observations

22 22 © Medtronic, Inc Reduce Dose → Reduce Side Effects 1 mg intrathecal morphine = 300 mg oral morphine Krames ES. J Pain Symptom Manage Jun;11(6):

23 23 © Medtronic, Inc Intrathecal Drug Delivery: Patient Selection Criteria I.Symptoms of pain due to advanced stage cancer at presentation, with a minimum life expectancy of >3 months 1-4 II.Refractory to conventional pain management because of drug toxicity or unsatisfactory analgesia 1-4 III.Visual analog scale (VAS) of ≥ 5, despite 200 mg/day of oral morphine or the analgesic equivalent 1,3,4 1. Smith TJ, Staats PS, Deer T, Stearns LJ, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refactory cancer pain: Impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19): Stearns L, Boortz-Marx R, Du Pen S, Friehs G, et al. Intrathecal Drug Delivery for the Management of Cancer Pain: A Multidisciplinary Consensus of Best Clinical Practices. J Support Oncol. 2005;3(6): Smith TJ, Coyne PJ. Implantable Drug Delivery Systems (IDDS) After Failure of Comprehensive Medical Management (CMM) Can Palliate Symptoms in the Most Refractory Cancer Pain Patients. J Pall Med. 2005;8(4): Brogan, SE. Intrathecal Therapy for the Management of Cancer Pain. Curr Pain Head Rep. 2006;10:

24 24 © Medtronic, Inc Intrathecal Drug Delivery: Patient Selection Criteria continued Consider those on lower doses if opioid side effects are refractory to conservative treatment and severe enough to prevent upward titration. 1,3,4 IV.Consider early evaluation of intrathecal drug delivery for those with pelvic tumors who may have eventual nerve compression Smith TJ, Staats PS, Deer T, Stearns LJ, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refactory cancer pain: Impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19): Stearns L, Boortz-Marx R, Du Pen S, Friehs G, et al. Intrathecal Drug Delivery for the Management of Cancer Pain: A Multidisciplinary Consensus of Best Clinical Practices. J Support Oncol. 2005;3(6): Smith TJ, Coyne PJ. Implantable Drug Delivery Systems (IDDS) After Failure of Comprehensive Medical Management (CMM) Can Palliate Symptoms in the Most Refractory Cancer Pain Patients. J Pall Med. 2005;8(4): Brogan, SE. Intrathecal Therapy for the Management of Cancer Pain. Curr Pain Head Rep. 2006;10:

25 25 © Medtronic, Inc When infection is present When pump implant depth exceeds depth specified in pump labeling Intrathecal Drug Delivery Contraindications –When body size is not sufficient to accept pump bulk and weight –When contraindications exist relating to the drug –Drugs with preservatives –Do not use the patient control device, if applicable, to administer opioid to opioid-naïve patients or to administer ziconotide For a complete list of contraindications, refer to the manufacturer labeling for the specific device. Contraindications to Intrathecal Drug Delivery

26 26 © Medtronic, Inc Initiating Intrathecal Drug Delivery Goals of care: –clearly expressed in regard to invasive therapy Pain-related factors: –pathophysiology amenable to intrathecal therapy Treatment-limiting side effects from systemic therapy: –somnolence or cognitive impairment Portenoy RK. Managing pain in patients with advanced cancer; the role of neuraxial infusion. Oncology. 1999;13(5 suppl 2):7-8.

27 27 © Medtronic, Inc Trial for Intrathecal Drug Delivery To evaluate patient’s response Assess pain relief Evaluate side effects 50% pain reduction considered a positive result Hassenbusch SJ, Stanton-Hicks M, Covington EC. Long-term intraspinal infusions of opioids in the treatment of neuropathic pain. J Pain Symptom Manage. 1995;10(5):

28 28 © Medtronic, Inc Intrathecal Drug Delivery: SynchroMed ® II Infusion System

29 29 © Medtronic, Inc Implanted Pump and Catheter Pump placement –Left or right abdomen –Enough tissue for support Catheter placement –Tunnel between spinal column and pump myPTM ® –Optional feature that gives patients the control and ability to respond to intermittent pain of varying intensity –Indicated only for preservative-free morphine Intraspinal Catheter Pump

30 30 © Medtronic, Inc Patient Management and Refills Refills and programming performed by trained clinician Refill complete in minutes Reimbursed procedure

31 31 © Medtronic, Inc Adverse Events with Intrathecal Drug Delivery Therapy There may be complications. The most frequently reported problems following intrathecal drug delivery system implant surgery include: Infection Spinal fluid leak Pump inversion Skin erosion Drug side effects Loss of therapy effect Therapy that did not meet the patient’s expectations Some of the most severe reported problems associated with intrathecal drug delivery therapy for intractable pain include: Inflammatory mass (a mass near the tip of the catheter) Spinal cord damage Meningitis Life-threatening drug adverse effects due to over infusion as a result of programming or patient monitoring errors or device malfunction Complications due to use of unapproved drugs or not using drugs in accordance with drug labeling

32 32 © Medtronic, Inc myPTM ® * for Management of Intermittent Pain The Medtronic myPTM ® is an optional feature of the SynchroMed II infusion system that allows patients to respond to intermittent pain of varying intensity with a physician-prescribed dose of medication from the pump. It is not for use with ziconotide. Prevalence of Intractable Pain 74% of patients –The percentage of patients with chronic non-cancer pain who experienced severe to excruciating breakthrough pain (n = 228) episodes/day –The mean number of breakthrough pain episodes (defined as transitory exacerbation of pain that occurs on a background of otherwise controlled pain) minutes/pain episode –Median duration of breakthrough pain episodes. 1 *In some cases, myPTM is a self-pay device. Check with your patient’s insurance before prescribing. 1. Portenoy RK, Bennett DS, Rauck R, et al. Prevalence and characteristics of breakthrough pain in opioid-treated patients with chronic noncancer pain. J Pain. August 2006;7(8):

33 33 © Medtronic, Inc myPTM ®* for Management of Intermittent, Variable Pain The nature of pain is that it is variable. The occurrence and severity may change at particular times of the day, may be associated with particular activity, or may be unpredictable and have no pattern. myPTM ® is an innovative enhancement to SynchroMed ® II infusion system that gives patients the control and ability to respond to symptoms of episodic pain at onset. *In some cases, myPTM is a self-pay device. Check with your patient’s insurance before prescribing.

34 34 © Medtronic, Inc Reimbursement Pump used for chemotherapy since 1988 FDA-approved for use with morphine in 1991 Implant, refills, and programming covered by Medicare and most private carriers (check regional carriers for coverage) Medtronic offers assistance with coding, coverage, and payment information

35 35 © Medtronic, Inc Cost Effectiveness of Intrathecal Therapy in Cancer Pain Infusion costs are generally comparable for externalized intraspinal and parental drug delivery because similar equipment is used. 1 One cost model showed the break even point at which it becomes less expensive to administer opioids with an intrathecal/implanted pump (rather than an epidural/external pump) is between three and six months after the start of pain management. 2 After approximately 12 weeks, an exteriorized system loses its cost advantage, mainly due to higher maintenance needs and higher drug costs Stearns L, Boortz-Marx R, Du Pen S, Friehs G, et al. Intrathecal drug delivery fo rthe management of cancer pain: a multidisciplinary consensus of best clinical practices. J Support Oncol 2005;3(6): Hassenbusch SJ. Cost modeling for alternate routes of administration of opioids for cancer pain. Oncol 1999 May;13(5 suppl 2): Brogan SE. Intrathecal therapy for the management of cancer pain. Curr Pain Head Rep 2006;10:

36 36 © Medtronic, Inc Clinical Outcomes Cancer Pain Trial, 2002 Randomized Prospective International (5 countries) Multicenter (21 centers) Clinical trial of efficacy of combining IDDS (Medtronic SynchroMed ® infusion system) and Comprehensive Medical Management (CMM) vs. CMM alone for patients with persistent cancer pain Journal of Clinical Oncology, Vol 20, No 19, October 1, 2002:

37 37 © Medtronic, Inc Conventional Medical Management Per AHCPR Guidelines First, by mouth By the clock, not p.r.n. By the WHO analgesic ladder For the individual, as pain perception is highly individual With attention to drug titration, side effects, and patient’s assessment of pain Agency for Health Care Policy and Research. Management of Cancer Pain: Clinical Practice Guideline, Number 9, AHCPR Pub. No , 1994:42-45.

38 38 © Medtronic, Inc Outcomes/Measures Primary Objective Measurement Methods Efficacy: ≥20% reduction in pain VAS or equal VAS with ≥20% reduction in mean toxicity score or ≥20% reduction in both pain VAS and toxicity Visual analog scale (VAS) Common Toxicity Criteria Composite scores from 15 measures of toxicity Side effects Persistence and changes in side effects over time Quality of life (QOL): measured for both patients and caregivers Brief Pain Inventory SF-12 Health Survey Caregiver Quality of Life Resource utilization/cost NCI-ASCO Economics Workbook Survival Kaplan-Meier life tables Secondary Objectives Findings Measurement Methods Smith TJ, Staats PS, Deer T, Stearns LJ, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: Impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19):

39 39 © Medtronic, Inc Pain Relief VAS: Mean Change CMM (n=72) IDDS (n=71) As Randomized As Treated (adjusted) IDDS As Treated (adjusted) Non- Implanted (n=89) Implanted (n=54) Non- Implanted (n=22) Implanted (n=49) Error bars are +/- 2 standard errors Mean Reduction in VAS at 1 Month Smith TJ, Staats PS, Deer T, Stearns LJ, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: Impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19):

40 40 © Medtronic, Inc Types of Patient Pain Smith TJ, Staats PS, Deer T, Stearns LJ, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: Impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19):

41 41 © Medtronic, Inc Results at 4 Weeks Clinical Success* –84.5% of IDDS patients experienced clinical success vs. 70.8% in CMM arm Pain reduction (VAS) –  39.1% for CMM,  51.5% for IDDS Composite toxicity (CTC) –  17.1% for CMM,  50.3% for IDDS (P=0.004) Side effects (CTC) –Fatigue and reduced consciousness significantly less with IDDS than CMM (P<0.05) –Impotence and pruritis worsened with CMM Smith TJ, Staats PS, Deer T, Stearns LJ, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: Impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19): * Defined as a ≥20% reduction in VAS pain score or equal pain with a ≥20% reduced toxicity.

42 42 © Medtronic, Inc Reduction in 15 Toxicities (as randomized) *Statistically significant (P<0.05) Individual Toxicity Reduction in Mean Severity CMM IDDS  Reduced libido Urticaria Pruritus Weight loss Vomiting Nausea Dehydration Constipation Anorexia Personality Memory loss Reduced level of consciousness Confusion Fatigue * * Impotence Smith TJ, Staats PS, Deer T, Stearns LJ, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: Impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19):

43 43 © Medtronic, Inc Serious Adverse Events Smith TJ, Staats PS, Deer T, Stearns LJ, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: Impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19):

44 44 © Medtronic, Inc Cancer Pain Trial Results Reduced pain Reduced side effects like fatigue and sedation Positive trend toward QOL* More patients achieved clinical success with IDDS Smith TJ, Staats PS, Deer T, Stearns LJ, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: Impact on pain, drug-related toxicity, and survival. J Clin Oncol. 2002;20(19): * Based on the Brief Pain Index Interference scores

45 45 © Medtronic, Inc Medtronic Resources Online Resources at professional.medtronic.com –Practice Development Toolkit –Reimbursement Support –Patient Education Materials Medtronic technical services – –Monday-Friday 7:00am-6:00pm CST –Emergency technical support 7 days a week, 24 hours a day Patient Services – –Monday-Friday 8:00am-5:00pm CST Coverage and Authorization Services – Medical Education and Training Courses –A variety of training and education opportunities to keep clinicians current with pain therapies –Talk to your local Medtronic representative or visit professional.medtronic.com Local Medtronic Representative –

46 46 © Medtronic, Inc SynchroMed ® II Drug Infusion System Please refer to the product disclosure for complete product details.

47 47 © Medtronic, Inc SynchroMed ® II Drug Infusion System Brief Summary SynchroMed® II Drug Infusion System Brief Summary: Product technical manuals and the appropriate drug labeling must be reviewed prior to use for detailed disclosure. Indications: US: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, and chronic intrathecal infusion of Lioresal® Intrathecal (baclofen injection) for the management of severe spasticity; chronic intravascular infusion of floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer. Outside of US: Chronic infusion of drugs or fluids tested as compatible and listed in the product labeling. Contraindications: Infection; implant depth greater than 2.5 cm below skin; insufficient body size; spinal anomalies; drugs with preservatives, drug contraindications, drug formulations with pH < 3, use of catheter access port (CAP) kit for refills or of refill kit for catheter access, blood sampling through CAP in vascular applications, use of Personal Therapy Manager to administer opioid to opioid- naïve patients or to administer ziconotide. Warnings: Non-indicated formulations may contain neurotoxic preservatives, antimicrobials, or antioxidants, or may be incompatible with and damage the system. Failure to comply with all product instructions, including use of drugs or fluids not indicated for use with system, or of questionable sterility or quality, or use of non-Medtronic components or inappropriate kits, can result in improper use, technical errors, increased risks to patient, tissue damage, damage to the system requiring revision or replacement, and/or change in therapy, and may result in additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug under- or overdose. Refer to appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, screening procedures and underdose and overdose symptoms and methods of management. Physicians must be familiar with the drug stability information in the product technical manuals and must understand the dose relationship to drug concentration and pump flow rate before prescribing pump infusion. Implantation and ongoing system management must be performed by individuals trained in the operation and handling of the infusion system. An inflammatory mass that can result in serious neurological impairment, including paralysis, may occur at the tip of the implanted catheter. Clinicians should monitor patients on intraspinal therapy carefully for any new neurological signs or symptoms, change in underlying symptoms, or need for rapid dose escalation. Inform patients of the signs and symptoms of drug under- or overdose, appropriate drug warnings and precautions regarding drug interactions, potential side effects, and signs and symptoms that require medical attention, including prodromal signs and symptoms of inflammatory mass.

48 48 © Medtronic, Inc SynchroMed ® II Drug Infusion System Brief Summary, Continued Failure to recognize signs and symptoms and seek appropriate medical intervention can result in serious injury or death. Instruct patients to notify their healthcare professionals of the implanted pump before medical tests/procedures, to return for refills at prescribed times, to carry their Medtronic device identification card, to avoid manipulating the pump through the skin, to consult with their clinician if the pump alarms and before traveling or engaging in activities that can stress the infusion system or involve pressure or temperature changes. Strong sources of electromagnetic interference (EMI), such as short wave (RF) diathermy and MRI, can negatively interact with the pump and cause heating of the implanted pump, system damage, or changes in pump operation or flow rate, that can result in patient injury from tissue heating, additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug underdose or overdose. Avoid using shortwave (RF) diathermy within 30 cm of the pump or catheter. Effects of other types of diathermy (microwave, ultrasonic, etc.) on the pump are unknown. Drug infusion is suspended during MRI; for patients who can not safely tolerate suspension, use alternative drug delivery method during MRI. Patients receiving intrathecal baclofen therapy are at higher risk for adverse events, as baclofen withdrawal can lead to a life threatening condition if not treated promptly and effectively. Confirm pump status before and after MRI. Reference product labeling for information on sources of EMI, effects on patient and system, and steps to reduce risks from EMI. Precautions: Monitor patients after device or catheter replacement for signs of underdose/overdose. Infuse preservative-free (intraspinal) saline or, for vascular applications, infuse heparinized solutions therapy at minimum flow rate if therapy is discontinued for an extended period of time to avoid system damage. EMI may interfere with programmer telemetry during pump programming sessions. EMI from the SynchroMed programmer may interfere with other active implanted devices (e.g., pacemaker, defibrillator, neurostimulator). Adverse Events: Include, but are not limited to, spinal/vascular procedure risks; infection; bleeding; tissue damage, damage to the system or loss of, or change in, therapy that may result in additional surgical procedures, a return of underlying symptoms, and/or a clinically significant or fatal drug underdose or overdose, due to end of device service life, failure of the catheter, pump or other system component, pump inversion, technical/programming errors, or improper use, including use of non-indicated formulations and/or not using drugs or system in accordance with labeling; pocket seroma, hematoma, erosion, infection; post-lumbar puncture (spinal headache); CSF leak and rare central nervous system pressure-related problems; hygroma; radiculitis; arachnoiditis; spinal cord bleeding/damage; meningitis; neurological impairment (including paralysis) due to inflammatory mass; potential serious adverse effects from catheter fragments in intrathecal space, including potential to compromise antibiotic effectiveness for CSF infection; anesthesia complications; body rejection phenomena; local and systemic drug toxicity and related side effects; potential serious adverse effects from catheter placement in intravascular applications. USA Rx Only Rev 0809

49 49 © Medtronic, Inc Questions?


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