Important Safety Information: Spinal Cord Stimulation

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. Diabetic patients may have more frequent and severe complications with surgery. A preoperative assessment is advised for some diabetic patients 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 diabetic patients. Refer to www.medtronic.com for product manuals for complete indications, contraindications, warnings, precautions and potential adverse events. Rx only. Rev 0422

Relieve painful diabetic peripheral neuropathy
with a non-opioid therapy

Have you tried multiple therapies like creams, medications, or opioids without finding relief? There is an FDA-approved non-drug therapy available for those with painful DPN who aren't getting relief or have difficult side effects from drugs.

How it helps. How it works.

A Patient's Story: Real Relief from DPN Pain

See how this therapy helped to relieve Deborah's painful DPN and enabled her to return to every day living.

How Medtronic SCS therapy works

Medication is often not enough to control DPN pain for many. Learn how a small implantable device can help relieve DPN pain.
Take 3 minutes to complete this short survey.... to see if this pain-relief therapy may be right for you.
Do you qualify

How do I know this therapy is right for me?

This therapy might be a good fit for individuals who:
Have had DPN pain for at least a year
Experience pain in the legs or feet, such as:  
- Numbness or tingling
- Shooting, stabbing, burning, or pins and needles
Have not had success managing DPN pain with their current treatment such as creams, medications, and opioids
Have DPN pain that negatively impacts sleep and quality of life
Take the next step

Medtronic SCS is proven to be safe and effective.

Studies have found that spinal cord stimulation (SCS) significantly reduces DPN pain, providing lasting relief, and provides better results for most patients compared to other treatments such as medication.

SCS has been proven to provide meaningful long-lasting pain relief for up to 10 years for moderate-to-severe DPN pain.1

86%

of patients experienced treatment success
after receiving SCS therapy for 1 year2*

17x

people with DPN are 17 times more likely to experience significant pain relief (3-5)

Answer a few questions to see if the small implantable device may be right for you.

See if you qualify!

*Success rates in a population of patients treated with SCS in two studies and followed for up to 10 years. Results may vary. Not everyone responds to SCS in the same way.

What to expect

1
Survey
Take the survey to understand if you may be a candidate for this therapy.
2
Discussion
Discuss your pain with a therapy expert and connect with a local pain clinic that can provide the therapy.
3
Consult
Schedule a consult appointment with a physician to see if this therapy may be right for you and learn about the different stimulators.
4
Trial
SCS therapy is available to "test drive" for 3-10 days to determine if the small device is a good option.
5
Begin your journey to pain relief.
Take the next step in your DPN pain journey and answer a few questions to learn if
this therapy might be an option for you.
Start your journey!

Have more questions?

Scroll down to take the survey. If it seems that this therapy may be right for you, our support team will call you to answer your questions and help you with the next steps!

Click here to view our FAQ

Find out if this therapy may be right for you

Understand the risks

Not everyone responds to SCS in the same way, and your experience may vary. Risks include infection, lead movement, pain at the implant site, and loss of therapy effectiveness. Please discuss in detail with your doctor. Patients with diabetes may have an increased risk for surgical complications. Talk to your doctor about your ability to undergo surgery. Please check with your insurance company for specific coverage to your health plan.

  • Zuidema X, et al. Long-term evaluation of spinal cord stimulation in patient with painful diabetic polyneuropathy: an eight-to-ten-year prospective cohort study. Neuromodulation 2022;1-7.
  • van Beek M, Geurts JW, Slangen R, et al. Severity of neuropathy is associated with long-term spinal cord stimulation outcome 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.
  • Medtronic Pain Therapy Clinical Summary M221494A016 Rev B. United States; 2022.
  • 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.
  • 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.