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Physician’s Manual — VNS Therapy Programming Software (8.1)
LivaNova at 1 (866) 882-8804 (U.S. and Canada) or +1 (281) 228-
7330 (Worldwide).
Patients should continue with regularly scheduled visits including System
Diagnostic testing to ensure proper device functionality. Ensure that
patients (epilepsy indication only) continue using their Magnets regularly
to verify that stimulation is felt as described in the labeling. All patients
should notify their physicians if stimulation feels different or not felt, so a
System Diagnostics test may be performed. For some patients, stimulation
may become less noticeable over time. A change in perception of
stimulation, without clinical symptoms such as an increase in seizures/
depressive symptoms or painful/erratic stimulation, may not indicate a true
device issue. Performing a System Diagnostics test is the only valid way to
ensure proper device function.
10.4.5.
Sudden decrease in estimated device longevity
(% battery power remaining)
Exposure of Demipulse Generators to specific conditions can temporarily
drain the Pulse Generator battery and shorten the battery life by
approximately 50%. Possible conditions include:
Electrosurgical equipment (e.g. electrocautery) used during
implantation or other surgical procedure near the Pulse Generator
Static electricity (i.e., electrostatic discharge or ESD) imparted to the
device during a surgical procedure
This occurrence is detectable during the implantation procedure by
performing a System Diagnostics test after the device has been secured in
the pocket as prescribed in the product labeling. However, if this condition
occurred and was not detected, it is possible that the longevity of the
implanted Pulse Generator could be degraded. A sudden and unexpected
decrease in the % battery remaining is a possible indication that the battery
life of the device has been reduced.
Note
: For more
information on battery
longevity, see the
Technical Information
part of the device
specific Physician’s
Manual.
A significant change in the Lead impedance or increase in programmed
stimulation parameters can also result in a change in the estimated %
battery power remaining. Evaluation of the change in % battery power
remaining between consecutive patient visits must be performed before
any stimulation parameters are adjusted. The Lead impedance should be
reviewed for a significant change if a sudden decrease in the estimated %
battery power remaining is observed. For further assistance, call LivaNova
at 1 (866) 882-8804 (U.S. and Canada) or +1 (281) 228-7330 (Worldwide).
If the device was damaged during the implantation, the device will still
function normally but will have a decreased battery life. Monitor the
patient closely for the Pulse Generator approaching IFI, N EOS, or EOS.
