Diabetic peripheral neuropathy (DPN) pain is a debilitating and progressive neurological disorder that significantly impacts quality of life and functional ability for those with diabetes. Treatment options can include medication, but they are often only partially eﬀective and can result in serious side eﬀects.1
What may start as an uncomfortable numbness in the feet can progress into a burning or stabbing pain that spreads into the legs, becoming progressively worse and excruciating. It may be nearly impossible to walk, stand or even rest and comfortably sit.
Risks include infection, lead movement, pain at the implant site, and loss of therapy effectiveness. Please discuss in detail with your doctor. Not everyone responds to SCS in the same way, and your experience may vary.
People living with diabetes may have an increased risk for surgical complications. Talk to your doctor about your ability to undergo surgery.
1. Sloan G, Alam, U, Selva rajah D, Tesfaye S.The Treatment of Painful Diabetic Neuropathy. Current Diabetes Reviews. July 2021.
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 http://www.medtronic.com for product manuals for complete indications, contraindications, warnings, precautions and potential adverse events.
Rx only. Rev 0422