Explanting The Dbs Extensions - Boston Scientific Vercise Gevia 16 Instrucciones De Uso

9. Loosen the connector Setscrew on the DBS Extension using the Torque Wrench provided.
Note: Be sure to fully insert the Torque Wrench before loosening the Setscrew. To tighten
the Setscrew, rotate the Torque Wrench clockwise. To loosen the Setscrew, rotate
the Torque Wrench counterclockwise.
10. Remove the DBS Lead from the DBS Extension.
11. Gently pull the remainder of the DBS Lead through the incision behind the ear.
WARNING: The DBS Lead should be pulled from the site behind the ear and not the site
near the burr hole to avoid a potential spread of infection toward the skull
opening.
12. If you are replacing the DBS Lead, follow the instructions in the appropriate lead manual as
listed on your DBS Reference Guide. If you are explanting the entire Vercise Gevia System,
continue on to the Explanting the DBS Extensions procedure. Otherwise, close the incisions.
13. Ship the explanted DBS Leads to Boston Scientific.

Explanting the DBS Extensions

1. Turn off the Stimulator.
2. Palpate the region under the scalp to locate the DBS Extension connector.
3. 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.
4. Cut the DBS Extension(s) at the tapered (proximal) end of the connector.
5. Loosen the connector Setscrew using the Torque Wrench provided.
CAUTION: Loosen the Setscrew only as much as necessary to remove the DBS Lead.
Loosening the Setscrew too much will cause it to fall out.
Note: To tighten the Setscrew, rotate the Torque Wrench clockwise. To loosen the
Setscrew, rotate the Torque Wrench counterclockwise.
6. Disconnect the DBS Extension connector. Return the DBS Extension connector to Boston
Scientific.
7. Expose and disconnect the DBS Extensions from the Stimulator by following the procedure in
"Explanting or Replacing the Stimulator."
8. Gently pull the DBS Extension through the tunnel from the Stimulator site.
WARNING: Avoid pulling towards the ear to reduce the potential for infection of the DBS
Leads.
9. Ship the explanted DBS Extensions to Boston Scientific.
Note: If the DBS Extension has broken, then it may be necessary to make additional
incisions or to pull one end of the DBS Extension out at the Stimulator site and the
other end from the DBS Extension connector site.
Vercise Gevia System Revisions and Explantation
Vercise Gevia™ 16 Contact IPG DFU
91168761-02 Rev A Page 9 of 397