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Patient's (and caregiver's) willingness to continue recharging activities as necessary
under all circumstances, (eg, power outages, travel, and hospitalizations), and
recognize the critical nature of maintaining a charged battery in the neurostimulator.
Patient information
Programming and patient control devices
Group selection - Patients should select the group recommended by the clinician for the
desired therapeutic effect. Use of another group may result in unpleasant stimulation
when stimulation is turned on.
Patient control devices may affect other implanted devices - Do not place the patient
control device over another type of active implanted medical device (eg, pacemaker,
defibrillator, another type of neurostimulator). The patient control device could
unintentionally change the operation of the other device.
Patient device handling - To avoid damaging the device, do not immerse it in liquid; do
not clean it with bleach, nail polish remover, mineral oil, or similar substances; and do not
drop it or mishandle it in a way that may damage it.
Patient device use - When operating a patient control device or charging system
(rechargeable models only), use special care near flammable or explosive atmospheres.
An interaction between the flammable or explosive atmospheres and the battery in the
device could occur. The consequences of using a battery-powered device near flammable
or explosive atmospheres are unknown.
Recharger use - Check for skin irritation or redness near the neurostimulator during
recharging. Do not sit or lie on the antenna, or apply excessive pressure to the antenna.
Take periodic breaks during prolonged recharging. Although no direct cause and effect
has been established, some patients have reported heating sensation, discomfort,
blistering not caused by heating, skin irritation, or redness near the implanted
neurostimulator during or after recharging. Contributing factors may include excessive
pressure on the antenna, prolonged recharging periods, or individual patient physiological
factors.
Patient activities
Activities requiring coordination - Loss of coordination is a potential side effect of DBS
Therapy. Patients should exercise reasonable caution when participating in activities
requiring coordination, including those that they were able to perform prior to receiving
DBS Therapy (eg, swimming).
Activities requiring excessive twisting or stretching - Patients should avoid activities
that may put undue stress on the implanted components of the neurostimulation system.
Activities that include sudden, excessive or repetitive bending, twisting, or stretching can
cause component fracture or dislodgement. Component fracture or dislodgement may
result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and
additional surgery to replace or reposition the component.
Component manipulation by patient - Advise your patient to avoid manipulating the
implanted system components (eg, the neurostimulator, the burr hole site). This can result
in component damage, lead dislodgement, skin erosion, or stimulation at the implant site.
14 English Information for prescribers 2017-05-01