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1 © Medtronic, Inc Medtronic Pain Therapies Referral Strategies for Managing Chronic Pain
2 © Medtronic, Inc Agenda Types of Pain Common Chronic Pain Conditions Introduction to Medtronic Neurostimulation Introduction to Medtronic Intrathecal Drug Delivery Patient Selection Neurostimulation Clinical Evidence Intrathecal Drug Delivery Clinical Evidence Role of Interventional Pain Specialist Case Study
3 © Medtronic, Inc Types of Pain
4 © Medtronic, Inc Pain Definitions The IASP defines pain as “an unpleasant sensory and emotional experience associated with actual or perceived tissue damage or described in terms of such damage” 1 Pain can be classified according to primary etiology 2 –Neuropathic –Nociceptive –Mixed neuropathic and nociceptive All types of pain can also be classified by duration 3 –Acute: less than 6 weeks –Sub-acute: between 6 weeks and 3 months –Chronic: lasting > 3-6 months 1 Merskey H, Bogduk N, eds. Classification of Chronic Pain, 2nd Ed. IASP Press Seattle, Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg Koes BW, et al. Br Med J. 2006;332:
5 © Medtronic, Inc Types of Neuropathic Pain Direct nerve root injury: radiculopathy –Battered root syndrome –Perineural fibrosis –Intrafascicular fibrosis –Adhesive arachnoiditis Peripheral deafferentation –Phantom limb pain –Sympathetic-mediated pain syndrome –Herpetic neuralgia –Diabetic polyneuropathy Central deafferentation-thalamic stroke Cole AJ. In Low Back Pain Handbook, 2 nd ed. 2003; pg
6 © Medtronic, Inc Mechanical low back pain –Discogenic pain –Joint pain Facet joint Sacroiliac joint –Pseudoarthrosis –Osteoporosis –Musculoskeletal trauma Types of Nociceptive Pain Cole AJ. In Low Back Pain Handbook, 2 nd ed. 2003; pg
7 © Medtronic, Inc Failed Back Surgery Syndrome (FBSS)* Idiopathic chronic pain syndrome Cancer pain *Also referred to as “post-surgical chronic back pain” Combined Nociceptive and Neuropathic Pain Cole AJ. In Low Back Pain Handbook, 2 nd ed. 2003; pg
8 © Medtronic, Inc Continuous or intermittent pain that has persisted for at least 3-6 months Severe chronic pain results in high disability and severe limitation of ability to work or complete daily activities Chronic Pain Smith BH, et al. Fam Pract. 2001;18:
9 © Medtronic, Inc Approx. 30 million Americans suffer from moderate to severe non-cancer-related chronic pain 1 Chronic pain results in over 40 million doctor visits and 515 million lost workdays annually 2 Approx. 300,000 back surgeries are performed in the U.S. per year to treat chronic lumbar pain with failure rates as high as 40% 3 The success rate decreases significantly with each subsequent back surgery 4 1. Chronic Pain in America: Roadblocks to Relief, avail at 2. Business Week, March 1, 1999; 3. Deer T, et al. Pain Med. 2004; 5:6-13;www.ampainsoc.org 4. Miller B, et al. Pain Practice. 2005;5: Many Americans Suffer
10 © Medtronic, Inc Common Chronic Pain Conditions
11 © Medtronic, Inc Chronic Pain Conditions Post-surgical chronic back pain or failed back Radicular pain syndrome or radiculopathies resulting in pain secondary to failed back or herniated disk Postlaminectomy pain Multiple back operations Unsuccessful disk surgery Degenerative disk disease, herniated disk pain refractory to conservative and surgical interventions Peripheral causalgia Epidural fibrosis Arachnoiditis or lumbar adhesive arachnoiditis Complex regional pain syndrome, reflex sympathetic dystrophy or causalgia
12 © Medtronic, Inc Complex Regional Pain Syndrome (CRPS) Chronic pain syndrome characterized by severe pain with autonomic changes in the painful region Affects up to 1.2 million Americans 1-3 Develops in response to a traumatic physical event (e.g., accident or medical procedure) May respond to neurostimulation therapy 1 Stanton-Hicks MD. An update interdisciplinary clinical pathway for CRPS: report of an expert panel. Pain Practice 2002; vol 2, no ; 2 Reflex Sympathetic Dystrophy Syndrome Association (RSDA). CRPS Treatment Guidelines. June 2006; 3 RSDA. CRPS/RSD Fact Sheet, CRPS Treatment Guidelines. June 2006
13 © Medtronic, Inc Structural causes can be identified post-operatively by CT scan, MRI, myelogram, or x-ray If no structural cause can be found, persistent pain may be neuropathic—caused by the prolongation of the original condition and/or by the additional physical impact of invasive surgery Patients may be candidates for neurostimulation therapy Failed Back Surgery Syndrome
14 © Medtronic, Inc Pain Management Treatment Options De Andrés J, Van Buyten J-P. Pain Practice. 2006;6:39-45
15 © Medtronic, Inc Barriers to Effective Pain Management Lyn ME, Coyne PJ, Watson AC. Pain Management Issues for Cancer Survivors. Cancer Practice. May/June 2002; Vol. 10, Suppl.1
16 © Medtronic, Inc Short-term efficacy –RCTs and observational studies demonstrate improvement in pain –No evidence to support dosing >180 mg morphine equivalent per day Long-term efficacy –No RCTs for longer than 8 months –Overall evidence is weak –No evidence of improved function Is Oral Opioid Therapy Effective for Chronic Pain? Ballantyne JC, Mao J. N Engl J Med, 2003;349:
17 © Medtronic, Inc Device therapies are now considered earlier in the treatment continuum Stamatos JM, et al. Live Your Life Pain Free, October Based on the interventional pain management experience of Dr. John Stamatos Pain Treatment Ladder
18 © Medtronic, Inc Introduction to Medtronic Neurostimulation
19 © Medtronic, Inc Delivers small electrical signals to the epidural space Inhibits pain signals before they reach the brain and replaces them with a tingling sensation that covers the specific areas where pain was felt Indicated for treatment of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain Neurostimulation Therapy
20 © Medtronic, Inc Neurostimulation Indication Medtronic Neurostimulation Systems are indicated for treatment of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain
21 © Medtronic, Inc History of Neurostimulation s Today First carotid sinus nerve stimulator First “dorsal column” stimulator Spinal cord stimulator widely used Medtronic introduces first programmable electrode system in U.S. First clinical implant of Itrel ® totally implantable neurostimulator More than 100,000 patients have received Medtronic neurostimulation therapy for chronic pain
22 © Medtronic, Inc An effective method of pain control for many patients Reduces or eliminates pain medications Non-destructive and less invasive than surgical alternatives Reversible – can be discontinued or surgically removed Systems reprogrammable without surgery Trial helps assess patient response Patient control within physician-set limits Benefits of Neurostimulation Kumar K, Nath RK, Toth C. Deep Brain Stimulation for Intractable Pain: A 15-year experience. Neurosurgery. 1997
23 © Medtronic, Inc Pain Therapy Trial provides an opportunity to measure the effectiveness of neurostimulation without making a long-term commitment –Gauge patient response –Provide an adjustment period –Explore therapy parameters –Improve therapy cost-effectiveness The goal is at least a 50% reduction in pain without intolerable side effects –Patient-specific goals may include less pain reduction but improved quality of life Neurostimulation Trial Kumar K, et al. Neurosurgery. 2006;58:
24 © Medtronic, Inc A percutaneous lead is positioned in the epidural space on the dorsal aspect of the spinal cord at the appropriate nerve root level(s) Electrical current from the lead generates paresthesias that can be adjusted in intensity and location to achieve the best pain coverage Leads are attached to an external pulse generator which supplies the current Patients can adjust stimulation to meet pain management needs Neurostimulation Trial
25 © Medtronic, Inc An incision is made over the spine to place lead A pocket is formed under the skin to hold the neurostimulator The lead is tunneled under the skin and connected to the neurostimulator The lead is connected to the neurostimulator, incisions are closed, and the procedure is complete Neurostimulation Implantation
26 © Medtronic, Inc Neurostimulation Procedure Overview
27 © Medtronic, Inc Lead migration resulting in loss of pain relief Intermittent or uncomfortable stimulation Stimulation in the wrong location Neurological damage during procedure Risk of infection at implantation Some Risks of Neurostimulation North R, Kidd D, Zahurak M, et al. Neurosurgery. 1993;32: For complete list of risks/complications, refer to product package insert
28 © Medtronic, Inc RESTORE ULTRA ® System
29 © Medtronic, Inc Introduction to Medtronic Intrathecal Drug Delivery
30 © Medtronic, Inc IDD therapy involves the delivery of pain medicine in the intrathecal space The pump is connected to a thin, flexible catheter; both are implanted under the skin Smaller doses of medication are needed for effective pain relief because drug is delivered directly to the pain receptors Intrathecal Drug Delivery (IDD) Therapy
31 © Medtronic, Inc Chronic intrathecal infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain Also indicated for chronic intrathecal infusion of Lioresal ® Intrathecal (baclofen injection) for severe spasticity, chronic epidural infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, and chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain Synchromed ® II Drug Infusion System Indications Lioresal ® is a registered trademark of Novartis Pharmaceuticals, Inc.
32 © Medtronic, Inc First clinical implant of programmable pump (became SynchroMed pump) for intrathecal morphine Market release of implantable programmable SynchroMed Pump (IV use for cancer chemotherapy) Market release of SynchroMed Pump (intrathecal morphine for cancer pain and non-malignant pain) More than 100,000 patients worldwide have a Medtronic pump for chronic pain History of Intrathecal Drug Delivery Today
33 © Medtronic, Inc Route of AdministrationRelative Potency (mg)* Oral Intravenous Epidural Intrathecal *Relative approximations based on clinical observations Lamer TJ: Mayo Clin Proc. May 1994;69(5): Approximate Equivalent Daily Doses of Morphine
34 © Medtronic, Inc Pain relief for patients who have not received adequate relief with conventional therapies Reduction in adverse effects from oral opioids such as nausea, vomiting, sedation, and constipation Decreased or elimination of oral analgesics Increased ability to perform activities of daily living Patient control within physician-set limits May be effective for patients who do not experience relief from neurostimulation therapy Benefits of IDD Therapy Lamer TJ: Mayo Clin Proc. May 1994;69(5):473-80; Paice JA, et al: J Pain Symptom Manage.1996;11(2):71-80.
35 © Medtronic, Inc The purpose of the trial is to assess the efficacy and side effects of intrathecal morphine Trialing methods include –Continuous epidural –Continuous intrathecal –Bolus epidural –Bolus intrathecal Patients who report at least 50% reduction in pain may be candidates for long-term therapy IDD Trial
36 © Medtronic, Inc IDD Implantation An incision is made over the spine for insertion of the catheter A pocket is formed under the skin to hold the IDD pump The catheter is tunneled under the skin and connected to the IDD pump, incisions are closed, and the procedure is complete
37 © Medtronic, Inc Implant Procedure for IDD
38 © Medtronic, Inc Programming error Drug concentration error Surgical complications, such as infection Catheter could become dislodged or blocked The pump could stop working Other side effects may occur IDD Therapy Risks For complete list of risks/complications, refer to product package insert Onofrio BM, Yaksh TL. J Neurosurg 1990;72: ; Winkelmueller M, Winkelmueller W. J Neurosurg 1996;85: ; Paice JA, Penn RD, Shott S. J Pain Symptom Manage 1996;11(2):71-80
39 © Medtronic, Inc SynchroMed II Infusion System
40 © Medtronic, Inc Neurostimulation –Rechargeable and Non- rechargeable neurostimulation systems –mySTIM ® patient programmer Intrathecal Drug Delivery –Programmable pump –myPTM™ Medtronic Pain Therapy Portfolio The most comprehensive line of medical devices for management of chronic pain
41 © Medtronic, Inc Patient Selection
42 © Medtronic, Inc Indications for Neurostimulation and Intrathecal Drug Delivery Therapy Cole AJ. In Low Back Pain Handbook, 2 nd ed. 2003; pg 362. Refer to full prescribing information for Medtronic Neurostimulation Systems and Synchromed® II and Isomed® Drug Infusion Systems
43 © Medtronic, Inc Patients who have neuropathic pain in a concordant anatomic distribution respond best to neurostimulation (NS) therapy Patients who have nociceptive pain in a concordant distribution respond best to Intrathecal Drug Delivery (IDD) Patients who do not respond well to NS may be candidates for IDD therapy Patient Selection Considerations Cole AJ. In Low Back Pain Handbook, 2 nd ed. 2003; pg 362.
44 © Medtronic, Inc Patient Selection Checklist Cole AJ. In Low Back Pain Handbook, 2 nd ed. 2003; pg 362. Refer Patient for a Pain Therapy Trial Failure of oral/transdermal opiate use or undesirable side effects More conservative therapies have failed An observable pathology exists that is concordant with the pain complaint Further surgical intervention is not indicated No serious untreated drug habituation exists Psychological evaluation and clearance for implantation has been obtained No contraindications to implantation exist
45 © Medtronic, Inc Neurostimulation Clinical Evidence
46 © Medtronic, Inc Primary outcome –Number of patients with ≥50% leg pain relief at 6 months (≥50% reduction in leg VAS) Secondary outcomes evaluated at 1, 3, 6, 9, 12, 18 and 24 months –Pain relief (leg and axial back VAS) –Quality of life (SF-36 and EQ-5D) –Function (Oswestry Disability Index) –Patient satisfaction –Need for drug or non-drug therapy for pain –Time away from work –Adverse events Medtronic PROCESS Study Kumar, et al. Pain 2007
47 © Medtronic, Inc Clinically Significant Leg Pain Relief Key Findings: ≥50% leg pain relief at 24 months, continued greater effect with SCS* in the per treatment/ITT analyses over 24 months * SCS (spinal cord stimulation) is a term for neurostimulation Kumar, et al. Pain 2007; n = 100
48 © Medtronic, Inc Significant Improvement in Function Key Findings: Significant improvement in function (Oswestry Disability Index) in SCS+CMM group over 24 months Kumar, et al. Pain 2007; n = 100
49 © Medtronic, Inc Significant Improvement in Quality of Life Kumar, et al. Pain 2007 Key Findings: Significant improvement in SCS+CMM group in 7/8 domains of QoL (SF-36) over 24 months Visual Analog Scale (VAS)
50 © Medtronic, Inc High Satisfaction Kumar, et al. Pain 2007; n = 100 Key Findings: Treatment satisfaction among patients continuing SCS+CMM at 24 months
51 © Medtronic, Inc Long-Term Pain Relief Kumar, et al. Neurosurgery 2006 Key Findings: 61.3% of failed back surgery syndrome patients with bilateral limb pain and 59.3% of patients with unilateral limb pain reported >50%
52 © Medtronic, Inc Neurostimulation is Most Effective When Considered Early Kumar K, et al. Neurosurg. 2006;58; < >15 Success Rate (%)
53 © Medtronic, Inc More Effective than Repeat Surgery North, et al. Neurosurgery 2005 ; n=45 Key Findings: Among patients available for long-term follow up, SCS was significantly more successful than reoperation: 9 (47%) of 19 patients randomized to SCS and 3 (12%) of 26 patients randomized to reoperation achieved at least 50% pain relief and were satisfied with treatment
54 © Medtronic, Inc Van Buyten J-P, et al. Eur J Pain 2001;5: ; n=125 pain cases; P<0.01 for all activities 10-Year Experience: Neurostimulation Improves Quality of Life 27% 30%42%44%
55 © Medtronic, Inc Intrathecal Drug Delivery Clinical Evidence
56 © Medtronic, Inc Back and Leg Pain Relief Deer, et al. Pain Medicine 2004; n=136 Key Findings: Numeric back pain ratings decreased >48%, and leg pain ratings decreased by 32% at 12-month follow up
57 © Medtronic, Inc Successful Disability Reduction Deer, et al. Pain Medicine 2004; n=136 Key Findings: Successful disability reduction was reported in 60% of patients at 6 months and in 66% at 12 months
58 © Medtronic, Inc Decreased Use of Pain Medications Deer, et al. Pain Medicine 2004; n=136 Key Findings: At 6 months, 65% of patients decreased their use of systemic opioids from baseline At 12 months, 42% of patients decreased their usage compared with the 6-month follow up 88.2% of patients were taking systemic opioids at baseline
59 © Medtronic, Inc Overall Global Pain Relief Roberts, et al., European Journal of Pain; n=88 Key Findings: Overall pain relief of ≥50% was reported by 82% of patients (40 of 49) Number of Patients Global Pain Relief (%)
60 © Medtronic, Inc Clinical Evidence Summary Neurostimulation Clinically significant leg pain relief Significant improvement –Function –Quality of life High satisfaction Long-term pain relief Most effective when considered early More effective than repeat surgery Intrathecal Drug Delivery Back and leg pain relief Successful disability reduction Decreased use of pain medication Overall pain relief
61 © Medtronic, Inc Clinical Evidence Risks 1. Cameron T. Safety and efficacy of spinal cord stimulation for the treatment of chronic pain: a 20-year literature review J Neurosrug (Spine 3) 100: , 2004; 2. Staats P. Complications of intrathecal therapy. Pain Medicine 2008; 9(S1):S102-S107 As with any surgical procedure, neurostimulation and IDD involve the risk of infection. Lead migration is the most common complication associated with neurostimulation, 1 while intrathecal catheters can fracture, kink, and migrate. 2 For a complete list of adverse events for implantable therapies, see the appropriate product labeling.
62 © Medtronic, Inc Role of Interventional Pain Specialist
63 © Medtronic, Inc A Multidisciplinary Team Approach
64 © Medtronic, Inc Practice Management Collaboration
65 © Medtronic, Inc Interventional Pain Specialist Pain Management Approach Recognizes unique benefits of technological advances and interventions Communicates with all concerned parties to ensure best treatment possible Develops follow-up plan once pain successfully treated Collaborates with referring physician when treatment overlaps with general health care Follows up with referring physician once pain is controlled
66 © Medtronic, Inc Interventional Pain Specialist Key Questions What types of pain are treated? How are services offered? Which treatments are offered? What type of follow-up is offered? Does the pain specialist: –Provide 24/7 coverage? –Have privileges at your admitting hospital? –Provide inpatient coverage for hospitalized patients?
67 © Medtronic, Inc Interventional Pain Specialist Referral Criteria Multiple symptoms or pain sources Conservative therapies not working Patient’s functional status deteriorated Uncomfortable prescribing or monitoring opioids
68 © Medtronic, Inc Device Therapy Referral Interventional Pain Specialist Role Conduct a thorough patient history and physical exam Develop an interventional pain treatment plan Conduct a Medtronic Pain Therapy trial Perform the Medtronic Pain Therapy implantation or refer after the trial Develop a follow-up plan with the patient
69 © Medtronic, Inc Summary With today’s treatments, patients should not have to wait for effective pain relief By partnering, we can help patients find the right pain treatment Together we can improve the quality of life for chronic pain patients Our decisions may change the course of a patient’s life
70 © Medtronic, Inc Case Study
71 © Medtronic, Inc Case Study Male, 45, office manager, no major psychosocial issues One spine surgery to treat herniated disc Referred from primary care physician to address axial back pain and secondary radicular pain that persists six months following anatomically corrective surgery Average back pain score (VAS) of 80/100 with diminished functional capacity Relief from physical rehabilitation therapy was not satisfactory Unsuccessfully treated with neuropathic pain agents and two systemic opioids, patient experienced extreme sedation and constipation Treated with nerve block series but relief was temporary
72 © Medtronic, Inc SynchroMed ® Infusion System Brief Summary 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: When infection is present; when the pump cannot be implanted 2.5 cm or less from the surface of the skin; 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 Personal Therapy Manager accessory to administer opioid to opioid-naïve patients or to administer ziconotide. Warnings: Comply with all product instructions for initial preparation and filling, implantation, programming, refilling, and injecting into the catheter access port (CAP) of the pump. Failure to comply with all instructions can lead to technical errors or improper use of implanted infusion pumps and result in additional surgical procedures, a return of underlying symptoms, or a clinically significant or fatal drug under- or overdose. Refer to the appropriate drug labeling for specific under- or overdose symptoms and methods of management. Avoid using short wave (RF) diathermy within 30 cm of the pump or catheter. Diathermy may produce significant temperature rises in the area of the pump and continue to heat the tissue in a localized area. If overheated, the pump may over infuse the drug, potentially causing a drug overdose. Effects of other types of diathermy (microwave, ultrasonic, etc.) on the pump are unknown. 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. For intraspinal therapy, use only preservative-free sterile solution indicated for intraspinal use. Use only Medtronic components indicated for use with this system. Failure to firmly secure connections can allow drug or cerebrospinal fluid (CSF) leakage into tissue and result in tissue damage or inadequate therapy. A postoperative priming bolus should not be programmed if the pump is a replacement and the catheter has not been aspirated.
73 © Medtronic, Inc SynchroMed ® Infusion System Brief Summary continued Refer to appropriate drug labeling for indications, contraindications, warnings, precautions, dosage and administration information, and screening procedures. Physicians must be familiar with the drug stability information in the technical manual 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. 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. Instruct patients to notify their clinician of travel plans, to return for refills at prescribed times, avoid activities such as strenuous exercise or contact sports that jar, impact, twist, or stretch the body, to always carry their Medtronic device identification card, to avoid manipulating the pump through the skin, and to notify healthcare professionals of the implanted pump before medical tests/procedures. Patients must consult their physician before engaging in activities involving pressure or temperature changes (e.g., scuba diving, saunas, hot tubs, hyperbaric chambers, flights, skydiving, etc.) Inform patients that pump has an Elective Replacement Indicator (ERI) that sounds when the pump is nearing its end of service. When the alarm sounds, patients must contact their doctor to schedule pump replacement. Precautions:The pump is ethylene oxide sterilized. Do not use if the product or package is damaged, the sterile seal is broken, or the “Use By” date has expired. Do not reuse or resterilize the pump; it is intended for “single use only.” Do not expose the pump to temperatures above 43°C or below 5°C. Consider use of peri- and post-operative antibiotics for pump implantation, for any subsequent surgical procedure, or if infection is present. For patients prone to CSF leaks, clinicians should consider special procedures, such as a blood patch. Follow instructions for emptying and filling the pump during a replacement or revisions that require removal of the pump from the pocket. Explant the pump postmortem if incineration is planned (to avoid explosion), or if local environmental regulations mandate removal. Return explanted devices to Medtronic for analysis and safe disposal. Do not implant a pump dropped onto a hard surface or showing signs of damage. Implant the pump less than 2.5 cm from the surface of the skin. Ensure pump ports will be easy to access after implant, that the catheter is not kinked and secured well away from pump ports before suturing. Keep the implant site clean, dry, and protected from pressure or irritation. If therapy is discontinued for an extended period of time, fill the reservoir with preservative-free saline in intraspinal applications or appropriate heparinized solution (if not contraindicated) in vascular applications. The magnetic field or telemetry signals produced by the programmer may cause sensing problems and inappropriate device responses with an implantable pacemaker and/or defibrillator. Electromagnetic interference (EMI) is an energy field generated by equipment found in the home, work, medical, or public environments. Most EMI normally encountered will not affect the operation of the pump. Exceptions include: injury resulting from heating of the pump which can damage surrounding tissue (diathermy, MRI), system damage which can require surgical replacement or result in loss/change in symptom control (defibrillation, electrocautery, high-output ultrasonics, radiation therapy), and operational changes to the pump causing the motor to stop, loss of therapy, return of underlying symptoms, and require confirmation of pump function (diathermy, high magnetic field devices, hyperbaric/hypobaric conditions, magnetic resonance imaging (MRI)). MRI will temporarily stop the pump motor’s rotor due to the magnetic field of the MRI scanner and suspend drug infusion during MRI exposure which will cause the pump alarm to sound. The pump should resume normal operation upon termination of MRI exposure. Prior to MRI, the physician should determine if the patient can safely be deprived of drug delivery. If not, alternative delivery methods for the drug can be utilized during the MRI scan. Prior to scheduling an MRI scan and upon its completion, pump status should be confirmed.
74 © Medtronic, Inc SynchroMed ® Infusion System Brief Summary continued Adverse Events: Include, but are not limited to, cessation of therapy due to end of device service life or component failure, change in flow performance due to component failure, inability to program the device due to programmer failure, CAP component failure; inaccessible refill port due to inverted pump, pocket seroma, hematoma, erosion, infection, post-lumbar puncture (spinal headache), CSF leak, radiculitis, arachnoiditis, bleeding, spinal cord damage, meningitis (intrathecal applications), anesthesia complications, damage to the pump, catheter and catheter access system due to improper handling and filling before, during, or after implantation; change in catheter performance due to catheter kinking, disconnection, leakage, breakage, occlusion, dislodgement, migration, or catheter fibrosis; body rejection phenomena, surgical replacement of pump or catheter due to complications; local and systemic drug toxicity and related side effects, complications due to use of unapproved drugs and/or not using drugs in accordance with drug labeling, or inflammatory mass at the tip of the catheter. !USA Rx Only
75 © Medtronic, Inc Neurostimulation Systems for Pain Therapy Disclosure 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. 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 Rx Only. November, 2007
76 © Medtronic, Inc Thank You
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