97745

Product image of the Intellis™ neurostimulation system with AdaptiveStim™ programming

Indications, Safety, and WarningsNeurostimulation systems for pain therapyBrief summary: Product manuals must be reviewed prior to use for detailed disclosure.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 have 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 such as an 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.

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