SPINAL CORD STIMULATORS

KEY POINTS

• More than 100 million Americans experience chronic pain lasting greater than 3 months, costing the nation approximately $560-635 billion annually in direct medical treatment costs and lost productivity.¹
• As an intervention for intractable chronic pain, spinal cord stimulation can be an effective alternative or adjunctive treatment to other therapies that have failed to manage pain on their own.²
• Spinal cord stimulation can be an effective non-opioid treatment for chronic intractable pain and are used to treat around 75,000 patients each year in the U.S. alone.³
• As with all products, Medtronic monitors for the safety of our products through the post market surveillance process and also reports safety information to regulators as appropriate.

Overview

1. Chronic Pain Impacts the Lives of Millions of Americans
   

   Chronic pain can restrict a patient’s mobility and daily activities, cause anxiety and depression, and impact quality of life. More than 100 million Americans experience chronic pain lasting greater than 3 months, costing the nation approximately $560-635 billion annually in direct medical treatment costs and lost productivity.¹
   

2. Medtronic Spinal Cord Stimulators Are FDA Approved as a Safe and Effective Option for Chronic Pain Relief
   

   As an intervention for intractable chronic pain, spinal cord stimulation can be an effective alternative or adjunctive treatment to other therapies that have failed to manage pain on their own. Wires, or leads, run from the device and are placed over areas of the spinal cord, delivering tiny electric impulses to treat the pain. Spinal cord stimulation is not right for everyone and requires a prescription. Spinal cord stimulation carries risks and should be fully discussed with a physician.
   

3. The Benefits of Spinal Cord Stimulators
   

   Spinal cord stimulation can be an effective non-opioid treatment for chronic intractable pain and is used to treat around 75,000 patients each year in the U.S. alone.² Published studies have shown that when used by carefully selected patients with chronic pain, spinal cord stimulation may offer the following benefits: (1) long-term pain relief; (2) improved quality of life; (3) more effective treatment than repeat surgery for persistent radicular pain after lumbosacral spine surgery; (4) successful pain disability reduction; and (5) more cost-effective than conventional medical management and reoperation.⁴
   

4. Medtronic Monitors the Safety of Spinal Cord Stimulators
   

   As with all products, Medtronic monitors for the safety of our products through the post market surveillance process and also reports safety information to regulators as appropriate.

   In addition, Medtronic chooses to maintain a Product Performance Registry that collects performance and safety data for many of our products, including spinal cord simulators. The data is collected in cooperation with a number of major healthcare centers in the United States, Europe, and South America and is posted annually on our website.

   Medtronic carefully considers the totality of available post-market data, including data from controlled clinical trials and studies conducted under real world-conditions, when available.

Supporting Statement from the North America Neuromodulation Society

Important Safety Information

Neurostimulation Systems For Pain Therapy

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.

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 (e.g., defibrillation, 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 in stimulation. Rupture or piercing of the neurostimulator can result in severe burns. An implanted cardiac device (e.g., 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. To properly assess test stimulation, 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. Patients using a rechargeable neurostimulator should check for skin irritation or redness near the neurostimulator during or after recharging.

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, gastrointestinal symptoms (diarrhea, constipation, and leakage of stool), bladder symptoms (urinary retention and frequency and leakage of urine) and surgical risks.
For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.

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Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.