Adverse Effects - Boston Scientific Precision SC-1110 Serie Manual De Uso

Component Disposal. Do not dispose of the
Remote Control or Charger in fire. The battery
in these devices can explode in fire. Dispose
of used batteries in accordance with local
regulations. The IPG should be explanted in
the case of cremation, and returned to Boston
Scientific. External devices to be disposed
of per local regulatory requirements. Please
contact your healthcare professional.
Remote Control, Charging System
Cleaning. The components can be cleaned
using alcohol or a mild detergent applied
with a cloth or tissue. Residue from soapy
detergents should be removed with a damp
cloth. Do not use abrasive cleansers for
cleaning.
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 or peripheral nerve
stimulation include:
• Lead migration, resulting in
undesirable changes in stimulation
and subsequent reduction in pain
relief.
Safety Information
• 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. 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.
• 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 and
neurostimulator displacement.
• Undesirable stimulation may occur
over time due to cellular changes in
tissue around the electrodes, changes
in electrode position, loose electrical
connections and/or lead failure.
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Clinician Manual