Vercise Gevia System Revisions And Explantation; Explanting The Dbs Lead - Boston Scientific Vercise Gevia Mode D'emploi

Vercise Gevia™ 16 Contact IPG DFU
7. Place the Stimulator in the subcutaneous pocket with the etched writing "This Side Up" facing
the skin, and parallel to the skin surface.
WARNING: Failure to orient the correct side of the Stimulator towards the skin may result in
the inability to charge and/or could require a revision surgery.
a. Coil the excess DBS Extension length under or around the Stimulator perimeter.
WARNING: Avoid placing the excess DBS Extension length on the superficial surface of
the Stimulator, as this may increase the potential for tissue erosion or charging
difficulty.
b. Optionally secure the Stimulator to the fascia by suturing through the holes in the
Stimulator header.
8. Close the incisions.
CAUTION: Be careful not to damage the DBS Lead, Stimulator, or other implanted
components when closing the incisions.
Note: When closing the incision over the extension connector, orient the extension
connector to minimize the profile under the skin.

Vercise Gevia System Revisions and Explantation

If the entire Vercise Gevia System (Stimulator, DBS Extensions, and DBS Leads) is to be removed,
then the DBS Leads should be removed first (as described below) followed by the DBS Extensions,
and lastly the Stimulator. This order will reduce the potential spread of infection toward the skull
opening.

Explanting the DBS Lead

WARNING: When explanting the Vercise Gevia DBS System, the DBS Lead should be
pulled from the site above the ear and not the site near the burr hole to avoid a
potential spread of infection toward the skull opening.
1. Turn off the Stimulator.
2. Palpate the scalp to locate the Burr Hole Cover (BHC).
3. Make an incision near the BHC to expose the BHC and DBS Lead. Be careful not to damage or
cut the DBS Lead or suture sleeve.
4. Cut the DBS Lead at a distance about 2-3 cm from the BHC, leaving enough length to grasp the
Lead.
5. Unscrew the screws anchoring the BHC.
6. Slowly and gently retract the DBS Lead from the neural tissue, pulling as close to perpendicular
to the skull as possible. The DBS Lead should experience minimal resistance when retracted.
7. Palpate the region under the scalp to locate the DBS Extension connector.
8. Create an incision to expose the DBS Lead and DBS Extension connector. Be careful not to
damage the implanted components to allow for proper analysis following explant.
Vercise Gevia™ 16 Contact IPG DFU
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