Vercise Pc System Revisions, Replacement, And Explantation; Explanting The Dbs Lead - Boston Scientific Vercise PC Ver DB 1140 Mode D'emploi

Vercise™ PC Implantable Pulse Generator DFU
10. Repeat steps 1 – 9 to tighten second Stimulator Setscrew and the Setscrew on the second
DBS Extension.
11. Place the Stimulator in the subcutaneous pocket.
a. Coil the excess DBS Extension length 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 damage
during Stimulator replacement surgery.
b. Optionally secure the Stimulator to the fascia by suturing through the holes in the
Stimulator header.
12. 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 PC System Revisions, Replacement, and
Explantation
If the entire Vercise PC 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 should reduce the potential spread of infection toward the skull
opening.

Explanting the DBS Lead

WARNING: When explanting the Vercise PC 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.
9. Loosen the connector Setscrew on the DBS Extension using the Torque Wrench provided.
Vercise™ PC Implantable Pulse Generator DFU
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