Adverse Effects - Boston Scientific Precision Manuel

at the intended pain site can be lost. If this
occurs, consult your physician who may able
to restore stimulation by reprogramming the
Stimulator in the clinic or repositioning the lead
during another operation.
Device Failure. Stimulators can fail at any
time due to random component failure, loss
of battery functionality, or lead breakage. If
the device stops working even after complete
charging (up to four hours), turn off the
Stimulator and contact your physician so that
the system can be evaluated.
Storage, Handling and Transport. Do not
expose the Remote Control or Charging
System components to excessively hot or cold
conditions. Do not leave the devices in your
car or outdoors for extended periods of time.
The sensitive electronics can be damaged
by temperature extremes, particularly high
heat. For proper operation, do not use the
Charger if the ambient temperature is above
35 °C (95 °F).
If the Remote Control or the Charging System
is to be stored for a period of time without
batteries, the storage temperature should not
exceed -20 to 60 °C (-4 to 140 °F).
Handle the system components and
accessories with care. Do not drop them or
submerge them in water. Although reliability
testing has been performed to ensure quality
manufacturing and performance, dropping the
devices on hard surfaces or in water, or other
rough handling, can permanently damage the
components. (See "Limited Warranty - IPG"
page 61.)
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 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. In some cases, the formation
90607862-22 Rev A
Safety Information
Clinician Manual
13 of 303