Adverse Effects - Boston Scientific Precision SC-5213 Manuel D'utilisation

Precision™ SCS System with MultiWave Technology Patient System Handbook

Adverse Effects

Potential risks are involved with any surgery. The possible risks of implanting a pulse generator as part of a system to deliver spinal
cord stimulation include:
• The lead(s) which deliver stimulation may move from their original implanted location, resulting in undesirable changes in
stimulation and subsequent reduction in pain relief.
• System failure, which can occur at any time due to random failure(s) of the components or the battery. These events, which may
include battery leakage, device failure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits
and lead insulation breaches, can result in ineffective pain control.
• Your body may react negatively to the materials used to manufacture the stimulator or the leads. You may notice redness, warmth
or swelling of the implant area. Tissue reaction to implanted materials can occur. In some cases, the formation of reactive tissue
around the lead in the epidural space can result in delayed onset of spinal cord compression and neurological/sensory deficit,
including paralysis. Time to onset is variable, possibly ranging from weeks to years after implant.
• The skin over your Stimulator may become thin and increasingly tender over time. A seroma may be formed.
• The most common surgical procedural risks are temporary pain at the implant site and infection. However, since the leads are
placed in the epidural space, there is a small risk that spinal fluid may leak from the lead insertion site following surgery. Very
rarely, you may develop an internal blood clot (hematoma) or blister (seroma); or you may experience epidural hemorrhage or
paralysis. Your spinal cord may become compressed.
• External sources of electromagnetic interference may cause the device to malfunction and affect stimulation.
• MRI. Exposure to magnetic resonance imaging (MRI) can result in noticeable heat near the Stimulator or the leads; may distort
or destroy the image needed for diagnosis; and may produce enough electromagnetic interference (EMI) to erase the Stimulator
programming, destroy the leads, or cause the leads to move from their intended location.
• Undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode
position, loose electrical connections and/or lead failure.
• You may experience painful electrical stimulation of your chest wall as a result of stimulation of certain nerve roots several weeks
after surgery.
• Over time, your Stimulator may move from its original position.
• You may experience weakness, clumsiness, numbness or pain below the level of implantation.
• You may experience persistent pain at the Stimulator or lead site.
In any event, you should contact your physician and inform him/her.
Patient System Handbook
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