Adverse Effects - Boston Scientific SPECTRA Manual Del Usuario

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 implant may become thin and increasingly tender over time. A seroma may be
formed.
safety information
Precision spectra™ system information for Patients
90970830-04 reV a 13 of 529