User Manual
Safety Information
15
ure, lead breakage, hardware malfunctions, loose con-
nections, electrical shorts or open circuits and lead
insulation breaches, can result in ineffective pain con-
trol.
• Tissue reaction to implanted materials can occur.
• Skin erosion or seroma at the IPG site can occur over
time.
• Possible surgical procedural risks are: temporary pain at
the implant site, infection, spinal cord compression,
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 cel-
lular changes in tissue around the electrodes, changes in
electrode position, loose electrical connections and/or
lead failure.
• The patient may experience painful electrical stimula-
tion of the chest wall as a result of stimulation of certain
nerve roots several weeks after surgery.
• Over time, the implant may move from its original posi-
tion.
• Weakness, clumsiness, numbness or pain below the
level of implantation.
• Persistent pain at the IPG or lead site.