Boston Scientific Neuromodulation Corporation PSC1110W ユーザーズマニュアル
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.
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.
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.
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.
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.
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.
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.
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.
tion.
•
Weakness, clumsiness, numbness or pain below the
level of implantation.
level of implantation.
•
Persistent pain at the IPG or lead site.