Adverse Effects - Boston Scientific Precision Novi Manual Del Usuario

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 the following:
• 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.
Safety Information
Precision Novi™ System Information for Patients
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