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Physician’s Manual — VNS Therapy Programming Software (8.1)
10.4.4.
Pulse Generator disabled due to Vbat < EOS
found at first interrogation after implantation or
other surgical procedure
Exposure of Models 103, 104, and 105 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.
Display of the following message during the first interrogation following
implantation may be an indication that the device was damaged during the
surgery:
“The Pulse Generator is currently disabled due to a Vbat < EOS
threshold. Note that the generator is NOT supplying stimulation. It is
recommended that you contact LivaNova or refer to the Physician's
Manual.”
If the device was damaged during the implantation, the device will still
function normally but may have a decreased battery life. If the "Vbat <
EOS" message is displayed during the first interrogation after implantation
of the device or other surgical procedure, physicians should:
1. Select the
Proceed
button at the bottom of the error message. The
Parameter screen appears.
2. Enter the desired device settings and select the
Program
button at the
bottom of the screen.
3. Perform a System Diagnostics test. If the following acceptable results
are obtained, the device is functioning normally, but the battery life
will be shortened.
Output Current: OK
Lead Impedance: OK
IFI = No
4. If Near EOS (N EOS) or EOS = Yes, it is recommended that the Pulse
Generator be replaced as soon as possible.
5. If any other error messages appear, see applicable Troubleshooting
sections within this physician's manual for assistance or contact
