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Indications, Safety, and Warnings

Spinal cord stimulation brief summary

INDICATIONS 
Spinal cord stimulation (SCS) is indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.

CONTRAINDICATIONS 
Diathermy - Energy from diathermy can be transferred through the implanted system and cause tissue damage resulting in severe injury or death.

WARNINGS 
Sources of electromagnetic interference (e.g., defibrillation, electrocautery, MRI, RF ablation, and therapeutic ultrasound) can interact with the system, resulting in unexpected changes in stimulation, serious patient injury or death. An implanted cardiac device (e.g., pacemaker, defibrillator) may damage a neurostimulator, and electrical pulses from the neurostimulator may cause inappropriate response of the cardiac device. Patients with diabetes may have more frequent and severe complications with surgery. A preoperative assessment is advised for some patients with diabetes to confirm they are appropriate candidates for surgery.

PRECAUTIONS 
Safety and effectiveness has not been established for pediatric use, pregnancy, unborn fetus, or delivery. Avoid activities that put stress on the implanted neurostimulation system components. Recharging a rechargeable neurostimulator may result in skin irritation or redness near the implant site.

ADVERSE EVENTS 
May include: undesirable change in stimulation (uncomfortable, jolting or shocking); hematoma, epidural hemorrhage, paralysis, seroma, infection, erosion, device malfunction or migration, pain at implant site, loss of pain relief, and other surgical risks. Adverse events may result in fluctuations in blood glucose in patients with diabetes. Refer to www.medtronic.com for product manuals for complete indications, contraindications, warnings, precautions and potential adverse events.
Rx only. Rev 0422

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TREATING DIABETIC NEUROPATHY

Take a step forward in how you treat chronic diabetic nerve pain.

Spinal cord stimulation (SCS) for your patients with moderate to severe diabetic peripheral neuropathy (DPN) pain

 

 

physician holding a pen and tablet consults with a patient.

Help your patients control the debilitating pain in their feet and legs.

For patients who experience chronic pain due to DPN and have not been satisfied by the levels of relief provided by oral pain medication, injections, or other treatments for pain, SCS can provide a new approach for patients looking for solutions.

SPINAL CORD STIMULATION

What is SCS?

Spinal cord stimulation is a proven, non-opioid, FDA-approved way to manage chronic pain that may be caused by DPN. SCS works by disrupting the pain signals traveling between the spinal cord and the brain.

Learn about SCS systems
Vanta and Intellis neurostimulators



Stimulation is delivered via a Medtronic Intellis™ or Vanta™ neurostimulator, a device similar to a pacemaker, implanted under the skin.

Potential benefits of SCS therapy

  • Patients with DPN are 17 times more likely to experience significant pain relief if treated with SCS compared to conventional treatment.1-3

  • 86% of patients experienced treatment success after receiving SCS therapy for one-year*4

  • Proven long-term therapy for managing chronic pain with the majority of patients experiencing meaningful pain relief through five years of treatment with SCS.4


17x

more likely to
experience significant
pain relief1-3



86%

of patients experienced treatment success after receiving SCS therapy
for 1-year*4



5yrs

of meaningful
pain relief4

Understand the risks

Risks include infection, lead movement, pain at the implant site, and loss of therapy effectiveness. Not everyone responds to SCS in the same way, and your patients’ experiences may vary. Risk of infection and severity of complications may be greater in diabetic patients.

Consider a preoperative risk assessment to determine if patients are healthy enough for surgery.

Monitor patients' glucose levels.

For a better understanding of risk and safety details associated with SCS therapy, and to get information about trials, procedures, benefits and features of Medtronic devices, download our brochures for referring physicians and implanters.

pdf Download referring
physician brochure (.pdf)

2.7MB

Get the brochure
Physician brochure
pdf Download Clinical Evidence Compendium (.pdf)

582KB

See the data
Physician brochure
pdf Download brochure
for surgeons (.pdf)

2.4MB

Get the brochure
Surgeon brochure

Talk to a
representative

If you have additional questions about spinal cord stimulation, sign up to speak with a Medtronic representative.

Learn more
about SCS

Visit the, Medtronic SCS website for healthcare professionals to get more information.

Reimbursement information

For reimbursement questions and information, contact us.

*

Success rates in a population of patients treated with SCS in two studies and followed for five years.

1

Medtronic. Medtronic Pain Therapy Clinical Summary M221494A016 Rev B. United States; 2022. 

2

de Vos CC, Meier K, Zaalberg PB, et al. Spinal cord stimulation in patients with painful diabetic neuropathy: A multicenter randomized clinical trial. Pain. 2014;155(11):2426–2431. doi:10.1016/j.pain.2014.08.031.

3

Slangen R, Schaper NC, Faber CG, et al. Spinal cord stimulation and pain relief in painful diabetic peripheral neuropathy: A prospective two-center randomized controlled trial. Diabetes Care. 2014;37(11):3016–3024. doi:10.2337/dc14-0684.

4

van Beek M, Geurts JW, Slangen R, et al. Severity of neuropathy is associated with long-term spinal cord stimulation outcomes in painful diabetic peripheral neuropathy: Five-year follow-up of a prospective two-center clinical trial. Diabetes Care. 2018;41(1):32–38. doi:10.2337/dc17-0983.

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.