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Help Patients Take Control of Chronic Pain 1. [Insert Speaker Name]* [Insert Practice Name and Location] [List Staff Members] [Insert Hospital/Practice.

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Presentation on theme: "Help Patients Take Control of Chronic Pain 1. [Insert Speaker Name]* [Insert Practice Name and Location] [List Staff Members] [Insert Hospital/Practice."— Presentation transcript:

1 Help Patients Take Control of Chronic Pain 1

2 [Insert Speaker Name]* [Insert Practice Name and Location] [List Staff Members] [Insert Hospital/Practice Photo] 2

3 Practice Overview [Insert Mission Statement] – Example: We aim to improve quality of life and functionality through a collaborative, multidisciplinary pain management program [Insert Practice Structure Information] – Example: Clinic, Multidisciplinary Practice, etc. [Insert Comprehensive Practice Treatment Examples] – Examples: Interventional Procedures, Medication Management, Physical Therapy, Referral to Specialists (chiropractor, surgeon, psychiatrist, rheumatologist) 3

4 Topics Chronic Pain and Its Impact Chronic Pain Patient Evaluation Medtronic Pain Therapies Clinical Evidence SureScan ® MRI Technology Patient Selection for Medtronic Pain Therapies Additional Resources 4

5 Chronic Pain and Its Impact Chronic pain affects 100 MILLION American adults* Annually costs nation up to $635 BILLION in medical treatment and lost productivity* *Institute of Medicine of the National Academies website. Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Accessed July 21, How many chronic pain patients did you see last week? 5

6 What Is Chronic Pain? Persistent pain that adversely affects well-being, level of function, and quality of life May be caused by injury, infection, or ongoing condition Stress, environmental, and affective factors may contribute Continues when treatment stops Types – Neuropathic: Results from damage or inflammation to nerves or nerve fibers – Nociceptive Pain: Typically arises from somatic and/or visceral structures Some Examples – Failed Back Syndrome, Spinal Stenosis, Radicular Pain Syndrome, Complex Regional Pain Syndrome, Cancer Pain, Compression Fractures from Osteoporosis 1.Task Force on Taxonomy of the International Association for the Study of Pain. In: Merskey H, Borgduk N, eds. Classification of Chronic Pain: Descriptions of Chronic Pain Syndromes and Definitions of Pain Terms. Merskey H, Borgduk N, eds. 2nd Edition. Seattle, WA: IASP Press; 1994 (reprinted 2002; updated 2011):Introduction page xi. Accessed July 21, 2014.http://www.iasp-pain.org/PublicationsNews/Content.aspx?ItemNumber=1673&navItemNumber=677 2.Loeser JD, Melzack R. Pain: an overview. Lancet 1999;353(916):

7 Chronic Pain Patient Evaluation Typical questions – Is pain acute or chronic? – Is it axial, peripheral? – Is there a radicular component? – What functional limitations are present? – Are there other associated symptoms (e.g., weakness, spasticity, bowel/bladder)? – Has patient responded to conventional treatments? – Has patient experienced complications or side effects from conventional treatments? 7

8 Chronic Pain Patient Evaluation History – Pain duration, onset, location, character – Associated symptoms (e.g. weakness, shortness of breath, vision changes, gait problems) – Previous therapies (e.g. PT/OT, injections, surgery, chiropractic care, biofeedback) – Other medical and family history (e.g. clotting disorders, substance abuse) Physical Exam – Rule out urgent processes – Identify potential pain sources – Determine if there is psychiatric or emotional involved 8

9 Chronic Pain Patient Evaluation Discussion of options – Patient preferences and goals – Functional role at home or in workplace – Medical co-morbidities – Family and work history – Economics – Indicated therapies Multidisciplinary effort Collaborative approach to patient care begins with you 9

10 Medtronic Pain Therapies These therapies may be: Effective alternatives when conventional therapies and systemic pain medications provide inadequate pain relief or intolerable side effects Reasonable alternatives to consider before performing irreversible, neurodestructive surgical procedures 1 Cost-effective interventions 2-4 generally covered and paid for by payers nationwide Prager J, Jacobs M. Evaluation of patients for implantable pain modalities: medical and behavioral assessment. Clin J Pain. 2001;17(3): Guillemette S, Witzke S, Leier J, Hinnenthal J, Prager JP. Medical cost impact of intrathecal drug delivery for noncancer pain. Pain Med. 2013;14(4): Taylor RS, Ryan J, O’Donnell R, Eldabe S, Kumar K, North RB. The cost-effectiveness of spinal cord stimulation in the treatment of failed back surgery syndrome. Clin J Pain. 2010;26(6): Kemler MA, Raphael JH, Bentley A, Taylor RS. The cost-effectiveness of spinal cord stimulation for complex regional pain syndrome. Value Health. 2010;13(6): Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Electrical Nerve Stimulators (160.7). database/details/ncd-details.aspx?NCDId=240&ncdver=1&DocID=160.7 &SearchType=Advanced&bc=IAAAABAAAAAA&. Accessed January 3, Centers for Medicare & Medicaid Services. National Coverage Determination (NCD) for Infusion Pumps (280.14). details/ncd-details.aspx?NCDId=223&ncdver=2&bc=AgAAQAAAAAAAAA%3d% 3d&. Accessed January 3, * Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary and the SynchroMed ® II Drug Infusion System Brief Summary at the end of this presentation for important risk and safety information. 10

11 Medtronic Pain Therapies Target Site of Action Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary and the SynchroMed ® II Drug Infusion System Brief Summary at the end of this presentation for important risk and safety information. Systemic Delivery of MedicationsTargeted Therapy Where it Matters 11

12 What is Spinal Cord Stimulation? Treatment targeted to the site of action An implantable spinal cord stimulator delivers small electrical signals through a lead implanted in the epidural space Patients feel a tingling sensation from the neurostimulation—instead of pain— in areas where the pain was felt In contrast, oral and transdermal pain medications must be absorbed systemically and cross the “blood-brain barrier” to reach pain signals 12

13 Spinal Cord Stimulation Trial – Patients can trial the therapy Temporary system Only component implanted is lead Patient uses system 3-10 days – Successful trial can be followed by implant Implantation of neurostimulator, lead(s), and extensions(s) if trial effective 13

14 Spinal Cord Stimulation Medtronic AdaptiveStim ® delivers better pain relief –88.7% ‡ of patients reported better pain relief vs. conventional stimulation 1,2 –Automatically delivers personalized, responsive, round-the-clock relief –Automatically adjusts stimulation based on the patient’s needs and preferences in different positions –Automatically collects objective patient activity data to support clinical decisions ‡RestoreSensor ® Clinical Study compared AdaptiveStim to Medtronic conventional stimulation; 88.7% is based on analysis of one of two questions that comprised the primary endpoint of improved convenience and/or better pain relief. Percentage based on respondents who completed the pain relief question. 1.Medtronic advanced pain therapy using neurostimulation for chronic pain. Clinical Summary, M221494A Schultz D, Webster L, Kosek P, Dar U, Tan Y, Sun M. Sensor-driven position-adaptive spinal cord stimulation for chronic pain. Pain Physician. 2012;15(1):1-12. * Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary at the end of this presentation for important risk and safety information. 14

15 What is Targeted Drug Delivery? An alternate route of delivering pain medications An implantable infusion system delivers pain medication to the site of action, the cerebrospinal fluid and spinal cord, to directly affect pain pathways – Physician programs dosing and delivery parameters – myPTM ® (an optional device) allows patients to self- administer boluses of morphine to manage unpredictable pain within physician-prescribed limits In contrast, oral and transdermal pain medications must be absorbed systemically and cross the “blood-brain barrier” to reach pain signals 15

16 Systemic vs. Targeted Delivery of Medications Systemic Dosing – Distributes drug via blood stream – High blood levels of drug – Brain receives highest proportion of drug – High dose of drug required (high elimination load) – Increase in systemic side effects Targeted Drug Delivery – Intrathecal drug distribution – Low blood levels of drug – Most drug binds to TARGET (spinal cord pain receptors) – Low dose of drug is effective (low elimination load) – Reduced systemic side effects on brain and gut Ruan X. Drug-related side effects of long-term intrathecal morphine therapy. Pain Physician. 2007;10:

17 Targeted Drug Delivery Trial –Patients can trial the therapy Bolus or in-dwelling catheter Assess for improvements in: –Pain scores –Physical function –Side effects –Successful trial can be followed by implant Implant –Implantation of infusion pump and intrathecal catheter –myPTM ® is optional for appropriate patients 17

18 1.Hamza M, Doleys D, Wells M, et al. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012;13(10): Ellis DJ, Dissanayake S, McGuire D, et al. Continuous intrathecal infusion of ziconotide for treatment of chronic malignant and nonmalignant pain over 12 months: a prospective, open-label study. Neuromodulation. 2008;11(1): Medtronic data on file. Approximately 122,000 implanted devices x 8760 patient-hours per year. * Please refer to the SynchroMed ® II Drug Infusion System Brief Summary at the end of this presentation for important risk and safety information. Targeted Drug Delivery 18

19 Clinical Evidence 100% of published Randomized Controlled Trials concerning implanted spinal cord stimulation or intrathecal drug delivery systems for chronic pain used Medtronic products 1-7 Through clinical evidence leadership and unparalleled reimbursement advocacy, Medtronic helps you reduce or eliminate economic and reimbursement barriers: References provided on next slide. –100% of evidence-based coverage policies use clinical study data to deny or approve therapy access –Medtronic provides the most Level 1 evidence documenting the effectiveness of spinal cord stimulation and targeted drug delivery

20 Clinical Evidence References 1.Kemler MA, Barendse GA, van Kleef M, et al. Spinal cord stimulation in patients with chronic reflex sympathetic dystrophy. N Engl J Med. 2000;343(9): North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1): Kumar K, Taylor RS, Jacques L, et al. Spinal cord stimulation versus conventional medical management for neuropathic pain: a multicentre randomised controlled trial in patients with failed back surgery syndrome. Pain. 2007;132(1-2): Schultz DM, Webster L, Kosek P, Dar U, Tan Y, Sun M. Sensor-driven, position-adaptive spinal cord stimulation for chronic pain. Pain Physician. 2012;15: Smith TJ, Staats PS, Deer T, 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): Rauck RL, Wallace MS, Leong MS, et al. A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage. 2006;31(5): Raphael JH, Duarte RV, Southall JL, Nightingale P, Kitas GD. Randomised, double-blind controlled trial by dose reduction of implanted intrathecal morphine delivery in chronic non- cancer pain. BMJ Open. 2013;3(7):e

21 Spinal Cord Stimulation Evidence* Long-term pain relief 1,2 Improved quality of life 1,2 More effective than repeat surgery for persistent radicular pain after lumbosacral spine surgery 3 Successful pain disability reduction 2 More cost-effective than conventional medical management and reoperation 4,5 * Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary at the end of this presentation for important risk and safety information. 1.Kumar K, Taylor RS, Jacques L, et al. The effects of spinal cord stimulation in neuropathic pain are sustained: a 24-month follow-up of the prospective randomized controlled multicenter trial of the effectiveness of spinal cord stimulation. Neurosurgery. 2008;63(4): ;discussion Harke H, Gretenkort P, Ladleif HU, Rahman S. Spinal cord stimulation in sympathetically maintained complex regional pain syndrome type I with severe disability. A prospective clinical study. Eur J Pain. 2005:9(4); North RB, Kidd DH, Farrokhi F, Piantadosi SA. Spinal cord stimulation versus repeated lumbosacral spine surgery for chronic pain: a randomized, controlled trial. Neurosurgery. 2005;56(1): Taylor RJ, Taylor, RS. Spinal cord stimulation for failed back surgery syndrome: a decision-analytic model and cost-effective analysis. Int J Technol Assess Health Care. 2005;21(3): North RB, Kidd D, Shipley J, Taylor RS. Spinal cord stimulation versus reoperation for failed back surgery syndrome: a cost effectiveness and cost utility analysis based on a randomized, controlled trial. Neurosurgery. 2007;61(2):

22 Targeted Drug Delivery Evidence* Effective pain relief 1-6 Reduced or eliminated use of pain medication 4-6 Reduced side effects compared to oral pain medication 1,5,7 Improved ability to function, return to work, and participate in activities of daily living 4,5,8,9 *Please refer to the SynchroMed ® II Drug Infusion System Brief Summary at the end of this presentation for important risk and safety information. 1.Smith TJ, Staats PS, Deer T, 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): Rauck RL, Wallace MS, Leong MS, et al. A randomized, double-blind, placebo-controlled study of intrathecal ziconotide in adults with severe chronic pain. J Pain Symptom Manage. 2006;31(5): Raphael JH, Duarte RV, Southall JL, Nightingale P, Kitas GD. Randomised, double-blind controlled trial by dose reduction of implanted intrathecal morphine delivery in chronic non-cancer pain. BMJ Open. 2013;3(7):e Deer T, Chapple I, Classen A, et al. Intrathecal drug delivery for treatment of chronic low back pain: report from the National Outcomes Registry for Low Back Pain. Pain Med. 2004;5(1): Hamza M, Doleys D, Wells M, et al. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012;13(10): Atli A, Theodore BR, Turk DC, Loeser JD. Intrathecal opioid therapy for chronic nonmalignant pain: a retrospective cohort study with 3-year follow-up. Pain Med. 2010;11(7): Ruan X. Drug-related side effects of long-term intrathecal morphine therapy. Pain Physician. 2007;10(2): Roberts LJ, Finch PM, Goucke CR, Price LM. Outcome of intrathecal opioids in chronic non-cancer pain. Eur J Pain. 2001;5(4): Winkelmüller M, Winkelmüller W. Long-term effects of continuous intrathecal opioid treatment in chronic pain of nonmalignant etiology. J Neurosurg. 1996;85(3):

23 Risks The most frequently reported problems following the surgery to implant a neurostimulation system include infection, lead movement, pain at the implant site, loss of therapy effect, and therapy that did not meet the patient's expectations. Targeted Drug Delivery risks may include infection, spinal fluid leak, paralysis, pump inversion, skin erosion, drug side effects (including under- or overdose), loss of therapy effect, and therapy that does not meet patient expectations. Please refer to the Neurostimulation Systems for Pain Therapy Brief Summary and the SynchroMed ® II Drug Infusion System Brief Summary at the end of this presentation for additional risk and safety information. 23

24 SureScan ® MRI Technology Medtronic makes safe access to MRI scans possible *† –Only Medtronic pain neurostimulation systems provide safe access to 1.5- Tesla MRI scans on any part of body* –Medtronic SynchroMed ® infusion systems provide safe full-body access to 1.5- and 3.0- Tesla MRI scans and resume programmed therapy after scan † This is important to consider when addressing patients’ future diagnostic needs 24 *Under specific conditions. Neurostimulation for pain requires SureScan ® implantable neurostimulator and Vectris ® leads. Refer to approved labeling for full list of conditions. † Targeted drug delivery for pain requires interrogation to confirm pump status. Refer to approved labeling for full list of conditions.

25 SureScan ® MRI Technology 1.Magnetic Resonance Imaging. Wikipedia. (Accessed May 30, 2013). 2.American College of Radiology. ACR Appropriateness Criteria®. Available at Accessed August 8, 2014.www.acr.org/ac Diagnostic Imaging: CT and MRI –Use the right diagnostic tool for the right patient condition 25

26 SureScan® MRI Technology 26 1.IMV MRI 2012 Benchmark Report. 2.Medtronic data on file. MRI is increasingly becoming the standard of care …

27 How Do You Identify Appropriate Patients for Medtronic Pain Therapies? Does the patient have chronic pain that has not responded effectively to more conventional treatments? Have clear, functional patient goals been established? Do patients and caregivers have realistic pain relief expectations? 27

28 Patient Expectations Establish specific, measureable goals Ensure patients have realistic expectations and ability to participate in a comprehensive treatment plan Discuss the importance of the trial *Medtronic Inc. Foundational Message Development for Patients Suffering from Chronic Pain. Qualitative Market Report. Oct “My expectation after the trial is that I knew it would work. Before the trial, I was very hesitant. The most important thing is the trial. The trial is the thing that tells you if it works or if it doesn’t.*” — Medtronic Targeted Drug Delivery patient 28

29 Medtronic Tools and Resources professional.medtronic.com 29

30 Clinician Support Targeted Drug Delivery: professional.medtronic.com/tdd 30

31 Clinician Support Spinal Cord Stimulation: professional.medtronic.com/scs 31

32 Clinician Support Product Performance Report: professional.medtronic.com/performance Training and education courses for healthcare professionals – E-learning – Contact your Medtronic representative to take advantage of varied opportunities 32

33 Patient Support Patient brochures and posters Tame the Pain website: tamethepain.com Physician Finder: tamethepain.com Patient Ambassador Program: tamethepain.com/painambassador Converse with a Nurse Program: tamethepain.com/nurse Medtronic Living Well Program: medtroniclivingwell.com Patient videos: youtube.com/medtronicchronicpain 33

34 Patient Support tamethepain.com 34

35 What Questions Do You Have? 35

36 Neurostimulation Systems for Pain Therapy Brief Summary Product Technical Manuals and Programming Guides must be reviewed prior to use for detailed disclosure. Indication for Use - Chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. Contraindications: Diathermy. Warnings: Defibrillation, diathermy, electrocautery, MRI, RF ablation, & therapeutic ultrasound can result in unexpected changes in stimulation, serious patient injury or death. Rupture/piercing of neurostimulator can result in severe burns. Electrical pulses from the neurostimulator may result in an inappropriate response of the cardiac device. Precautions: The safety and effectiveness of this therapy has not been established for: pediatric use, pregnancy, unborn fetus, or delivery. Follow programming guidelines & precautions in product manuals. Avoid activities that stress the implanted neurostimulation system. EMI, postural changes, & other activities may cause shocking/jolting. Patients using a rechargeable neurostimulator should check for skin irritation or redness near the neurostimulator during or after recharging. Adverse Events: Undesirable change in stimulation; hematoma, epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief, chest wall stimulation, & surgical risks. For full prescribing information, please call Medtronic at and/or consult Medtronic’s website at USA Rx Only Rev

37 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. 37

38 SynchroMed ® II Drug Infusion System Brief Summary 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. 38

39 SynchroMed ® II Drug Infusion System Brief Summary Warnings: 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. 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. 39

40 SynchroMed ® II Drug Infusion System Brief Summary 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. Lioresal ® is a registered trademark of Medtronic, Inc.USA Rx Only Rev


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