Adverse Effects - Boston Scientific Precision SC-1110 Mode D'emploi

Precision™ Spinal Cord Stimulator System Clinician Manual
Remote Control, Charging System Cleaning. The components can be cleaned using alcohol or
a mild detergent applied with a cloth or tissue. Residue from soapy detergents should be removed
with a damp cloth. Do not use abrasive cleansers for cleaning.
Cell Phones. While we do not anticipate any interference with cell phones, the full effects
of interaction with cell phones are unknown at this time. If there is a concern or a problem is
encountered, the physician should be contacted.

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:
• Lead migration, 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 device failure, lead breakage, hardware malfunctions,
loose connections, electrical shorts or open circuits and lead insulation breaches, can result in
ineffective pain control.
• 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.
• Skin erosion at the IPG site can occur over time.
• Possible surgical procedural risks are: temporary pain at the implant site, infection,
cerebrospinal fluid (CSF) leakage and, although rare, epidural hemorrhage, seroma, hematoma
and paralysis.
• External sources of electromagnetic interference may cause the device to malfunction and affect
stimulation.
• Exposure to MRI can result in heating of tissue, image artifacts, induced voltages in the
neurostimulator and/or leads, lead dislodgement.
• 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.
• The patient may experience painful electrical stimulation of the chest wall as a result of
stimulation of certain nerve roots several weeks after surgery.
• Over time, the Stimulator may move from its original position.
• Weakness, clumsiness, numbness or pain below the level of implantation.
• Persistent pain at the IPG or lead site.
In any event, instruct the patient to contact their physician to inform him/her.
Clinician Manual
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