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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.
•
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.
Adverse Effects
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