Download Presentation Title - Medtronic Neuromodulation

Developments in the
Treatment of Chronic Pain
Agenda
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Welcome
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
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Welcome
• <Insert name(s) of physician presenter(s),
practice name/logo, physician photo(s)>
• <Insert patient speaker(s) name(s), type of
therapy>
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Types of Pain
Types of Neuropathic Pain
• Results from damage to nerves
– Direct nerve root injury: Radiculopathy
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Battered root syndrome
Perineural fibrosis
Intrafascicular fibrosis
Adhesive arachnoiditis
– Peripheral deafferentation
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Phantom limb pain
Sympathetic-mediated pain syndrome
Herpetic neuralgia
Diabetic polyneuropathy
– Central deafferentation-thalamic stroke
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 361-374
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Types of Nociceptive Pain
• Results from damage to muscle, tissue, and
organs
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Cuts and bruises
Bone fractures
Burns
Mechanical low back pain
Most postsurgical pain
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Combined Nociceptive and Neuropathic Pain
• Failed back surgery syndrome (FBSS)*
• Idiopathic chronic pain syndrome
• Cancer pain
*Also referred to as “postsurgical chronic back pain”
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 361-374.
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Some Chronic Pain Conditions
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Postsurgical chronic back pain or failed back
Radicular pain syndrome or radiculopathies
Fibromyalgia
Peripheral causalgia
Arachnoiditis
Complex regional pain syndrome
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Rethinking the Pain Treatment Ladder
In contrast to earlier thinking on
the order of treatments in the
pain treatment continuum,1 it
has been proposed that device
therapies be considered at an
earlier stage.2
1Krames
ES. Intraspinal Opioid Therapy for Nonmalignant Pain:
Current Practices and Clinical Guidelines. J Pain Symptom
Manage 1996;11:333-352.
2Stamatos JM, et al. Live Your Life Pain Free, October 2005.
Based on the interventional pain management experience of Dr.
John Stamatos.
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Introduction to
Medtronic Neurostimulation
Neurostimulation Therapy
• Delivers 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 is felt
• Indicated for management of
chronic, intractable pain of the
trunk and/or limbs, including
unilateral or bilateral pain
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Benefits of Neurostimulation
• An effective method of pain control for many patients
when used as directed
• May reduce the need for pain medications
• Less invasive than surgical alternatives
• Reversible—can be discontinued or, if desired by the
patient, surgically removed
• Systems reprogrammable without surgery
• Trial helps assess patient response
• Patient control within preprogrammed limits
Kumar K, Taylor R, Jacques L, et al. Neurosurgery. 2008;63:762-770.
Burchiel KJ, Anderson VC, Brown FD, et al. Prospective, multicenter study of spinal cord stimulation
for relief of chronic back and extremity pain. Spine. 1996;21:2786-2794.
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Neurostimulation Trial
• Neurostimulation therapy trial provides an
opportunity to assess the effectiveness of
neurostimulation without making a long-term
commitment
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Gauge patient response
Provide an adjustment period
Explore therapy parameters
Improve therapy cost-effectiveness
• The goal is at least a 50% reduction in pain
– Patient-specific goals may include less pain reduction
but improved quality of life
Kumar K, Hunter G, Demeria D. Spinal cord stimulation in treatment of chronic benign pain.
Challenges in treatment planning and present status, a 22-year experience. Neurosurgery.
2006;58(3):481-496.
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Neurostimulation Risks
The most frequently reported problems following the spinal
cord stimulator implant surgery include:
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infection,
lead movement,
pain at the implant site,
loss of therapy effect, and
therapy which did not meet the patient's expectations.
Some of the most severe reported problems following spinal
cord simulator implant surgery include epidural hemorrhage,
spinal fluid leakage, and paralysis.
For more details on risks/complications, refer to product package insert or visit www.medtronic.com.
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Neurostimulation Risks (cont.)
Information sources:
Medtronic Neurostimulation Therapy for Chronic Pain:
Percutaneous Lead Implantation Guide. Minneapolis, MN:
Medtronic, Inc.; 2008.
Medtronic Implantable Systems Performance Registry (ISPR)
2007 Annual Report: Protocol NSP0010-10000. Minneapolis,
MN: Medtronic, Inc.; October 2, 2008.
Medtronic Neurostimulation Systems for Pain Therapy Brief
Summary; Minneapolis, MN: Medtronic, Inc.; December 2004.
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Introduction to
Medtronic Intrathecal
Drug Delivery (IDD)
Intrathecal Drug Delivery (IDD) Therapy
• IDD therapy involves the delivery
of pain medicine into 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
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Synchromed® II Drug Infusion System Indications
• Chronic intrathecal infusion of preservative-free
morphine sulfate sterile solution in the treatment
of chronic intractable pain
• Also indicated for chronic intrathecal infusion of
preservative-free ziconotide sterile solution for
the management of severe chronic pain
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Approximate Equivalent Daily Doses of
Morphine
Route of
Administration
Relative Potency
(mg)*
Oral
Intravenous
Epidural
Intrathecal
300
100
20
1
*Relative approximations based on clinical observations.
Lamer TJ. Treatment of cancer-related pain: when orally administered medications fail.
Mayo Clin Proc. 1994;69:473-480.
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Benefits of IDD Therapy
• Pain relief for patients who have not received adequate
relief with conventional therapies
• May reduce adverse effects from oral opioids such as
nausea, vomiting, sedation, and constipation
• May decrease or eliminate use of oral analgesics
• Increased ability to perform activities of daily living
• Patient control of medication within physician-set limits
• May be effective for patients who do not experience relief
from neurostimulation therapy
Lamer TJ: Mayo Clin Proc. May 1994;69(5):473-80.
Paice JA. Intraspinal morphine for chronic pain: a retrospective, multicenter study. J Pain Symptom
Manage. 1996;11:71-80.
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IDD Trial
• The purpose of the trial is to assess the efficacy
and side effects of intrathecal morphine
• Trialing methods include:
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Continuous epidural
Continuous intrathecal
Bolus epidural
Bolus intrathecal
• Patients who report at least 50% reduction in
pain may be candidates for long-term therapy
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IDD Therapy Risks
The most frequently reported problems following drug infusion system implant
surgery include:
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infection
spinal fluid leak
pump inversion
dislodged or blocked catheter
skin erosion
• drug side effects
• loss of therapy effect
• therapy which did not meet the
patient’s expectations
Other complications may occur, and may require surgery to correct.
Some of the most severe reported problems associated with intrathecal drug
delivery therapy for chronic pain include inflammatory mass, 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,
and complications due to use of unapproved drugs and/or not using drugs in
accordance with drug labeling.
For more details on risks/complications, refer to product package insert or visit www.medtronic.com.
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IDD Therapy Risks (cont.)
Information sources:
Medtronic Synchromed II Programmable Infusion System Clinical
Reference Guide: Intrathecal Morphine for Pain Management.
Minneapolis, MN: Medtronic, Inc.; May 2007.
Medtronic Implantable Systems Performance Registry (ISPR) 2007
Annual Report: Protocol NSP0010-10000. Minneapolis, MN: Medtronic,
Inc.; October 2, 2008.
Synchromed II Drug Infusion System Brief Summary; Minneapolis, MN:
Medtronic, Inc.; January 2008.
Coffey R. Mortality Associated with Intrathecal Opioid Drug Infusion to
Treat Non-Cancer Pain: Risk Factors and Mitigation. Paper presented
at the North American Neuromodulation Society 12th Annual Meeting;
December 4-7, 2008; Las Vegas, NV.
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Patient Selection
Indications for Neurostimulation and
Intrathecal Drug Delivery Therapy
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362.
Refer to full prescribing information for Medtronic Neurostimulation Systems and Synchromed® II
Drug Infusion Systems.
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Patient Selection Considerations
• Patients who have neuropathic pain in a
concordant anatomic distribution usually respond
best to neurostimulation (NS) therapy.
• Patients who have nociceptive pain in a
concordant distribution usually respond best to
intrathecal drug delivery (IDD).
• Patients who do not respond well to NS may be
candidates for IDD therapy.
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362.
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Patient Selection Checklist
 Failure of oral/transdermal opiate use or
intolerable 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
 Refer Patient for a Pain Therapy Trial
Cole AJ. In Low Back Pain Handbook, 2nd ed. 2003; pg 362.
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Neurostimulation
Clinical Evidence
Medtronic PROCESS Study Results
Primary outcome
Number of SCS + CMM patients with ≥ 50% leg
pain relief (≥ 50% reduction in leg VAS) is:
– at 6 months, 23 of 42 or 55%
– at 12 months, 16 of 42 or 38%
– at 24 months, 17 of 42 or 40%
Kumar K, Taylor R, Jacques L, et al. Neurosurgery. 2008;63:762-770.
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Medtronic PROCESS Study Results
• Secondary outcomes evaluated at 1, 3, 6, 9, 12, 18 and
24 months (24 month data presented)
Leg pain relief (leg VAS)
Leg: Significant improvement
(p<0.0001)
Back pain relief (axial back VAS)
No significant difference
Quality of life (SF-36 and EQ-5D)
SF-36: significant improvement for 7 of
8 dimensions
EQ-5D: significant improvement
Function (Oswestry Disability
Index)
Significant improvement (p=0.0002)
Patient satisfaction
93% satisfied with treatment
Need for drug or nondrug therapy
for pain
No clear pattern of change
Work status
Increased from 21% to 27%
Adverse events
See Adverse Events slide
Kumar K, Taylor R, Jacques L, et al. Neurosurgery. 2008;63:762-770.
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Significant Improvement in Function
Key Findings: Significant improvement in function (Oswestry Disability Index)
in SCS+CMM group over 24 months.
Kumar K, Taylor R, Jacques L, et al. Neurosurgery. 2008;63:762-770.
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More Effective than Repeat Surgery
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.
North RB, Kidd D, Shipley J, et al. Spinal cord stimulation versus reoperation for failed
back surgery syndrome: a cost effectiveness and cost utility analysis based on a
randomized, controlled trial. Neurosurg. 2007;61:361-369.
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Efficacy of Spinal Cord Stimulation
Neurostimulation Improves Quality of Life
• Subjects were implanted with SCS over a period of 10 years at one pain center
• Efficacy assessed after an average follow-up of almost four years
Van Buyten JP, Van Zundert J, Vueghes P, Vanduffel L. Efficacy of spinal cord stimulation:
10 years of experience in a pain centre in Belgium. Eur J Pain 2001;5:299-307. n=125 pain
cases; P<0.01 for all activities
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Intrathecal Drug Delivery
Clinical Evidence
Decreased Use of Pain Medications
88.2% of patients were
taking systemic opioids at
baseline.
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.
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;5:6-13. n=136
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Overall Global Pain Relief
Key Findings:
Overall pain
relief of ≥ 50%
was reported by
82% of patients
(40 of 49).
Roberts LJ, Finch PM, Goucke CR, et al. Outcome of intrathecal opioids in chronic non-cancer
pain. Eur J Pain. 2001;5:353-361. n=88
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Role of Interventional
Pain Specialist
Practice Management Collaboration
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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 when pain is
under better control
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Interventional Pain Specialist
Referral Considerations
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Intractable pain
Intolerable side effects from systemic analgesics
Conservative therapies ineffective
Patient’s functional status declines
Uncomfortable prescribing or monitoring opioids
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Case Study – Sample Referral Profile
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 6 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
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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 and
primary/referring physician
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Summary
• 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.
43 | MDT Confidential
SynchroMed® 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: 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 opioidnaïve 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.
44 | MDT Confidential
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.
45 | MDT Confidential
SynchroMed® Infusion System
Brief Summary continued
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.
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 Rev 0209
46 | MDT Confidential
Neurostimulation Systems for Pain Therapy
Disclosure
Brief Summary: Product manuals must be reviewed prior to use for detailed disclosure.
Indications
Implantable neurostimulation systems - A Medtronic implantable neurostimulation system is indicated for spinal cord
stimulation (SCS) system as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including
unilateral or bilateral pain associated with the following conditions:
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Failed Back Syndrome (FBS) or low back syndrome or failed back
Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk
Postlaminectomy pain
Multiple back operations
Unsuccessful disk surgery
Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions
Peripheral causalgia
Epidural fibrosis
Arachnoiditis or lumbar adhesive arachnoiditis
Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia
Contraindications
Diathermy - Do not use shortwave diathermy, microwave or therapeutic ultrasound diathermy (all now referred to as
diathermy) on patients implanted with a neurostimulation system. Energy from diathermy can be transferred through
the implanted system and cause tissue damage at the locations of the implanted electrodes, resulting in severe injury
or death.
Warnings
Sources of strong electromagnetic interference (eg, defibrillation, diathermy, electrocautery, MRI, RF ablation, and
therapeutic ultrasound) can interact with the neurostimulation system, resulting in serious patient injury or death. These
and other sources of EMI can also result in system damage, operational changes to the neurostimulator or unexpected
changes
47 | MDT Confidential
Neurostimulation Systems for Pain Therapy
Disclosure continued
in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac
device (eg, pacemaker, defibrillator) may damage a neurostimulator, and the 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 (patients under the age of
18), pregnancy, unborn fetus, or delivery. Patients should be detoxified from narcotics prior to lead placement.
Clinicians and patients should follow programming guidelines and precautions provided in product manuals.
Patients should avoid activities that may put undue stress on the implanted neurostimulation system
components. Patients should not scuba dive below 10 meters of water or enter hyperbaric chambers above 2.0
atmosphere absolute (ATA). Electromagnetic interference, postural changes, and other activities may cause
shocking or jolting.
Adverse Events
Adverse events may include: undesirable change in stimulation described by some patients as uncomfortable,
jolting or shocking; 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, and
surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at
www.medtronic.com.
USA Rx Only
Rev 0209
48 | MDT Confidential
Thank You