Document Reference: ENG-UMAN-000730
Revision: 6.00
Page 22 of 40
8
Trial with a Temporary Percutaneous Lead
Note:
After completing steps 5.2.1 to 5.2.4 proceed to section 8.1.
Remove the stylet and epidural needle
1.
Carefully withdraw the epidural needle from the insertion site by sliding it along the
percutaneous lead until clear of the body.
2.
Carefully withdraw the stylet from the lead ensuring that the percutaneous lead
position does not change.
3.
Slide the epidural needle completely from the percutaneous lead.
4.
Confirm lead position with fluoroscopy if required.
Anchor the lead, close and dress the incisions
1.
Using preferred techniques, close and dress the incision at the lead insertion site.
2.
Using preferred method, ensure that the lead is firmly attached to the skin to
minimize potential lead migration during the trial period.
Caution:
Suturing directly to the percutaneous lead may damage the lead or cause
it to fail.
Post-Operative Procedures
For post-operative procedures and programming refer to the Evoke™ Clinical Manual.
Removing a Percutaneous Lead at the End of a Trial
1.
Disconnect the lead adapter cable (or lead adapter extension) from the eCLS.
2.
Disconnect the lead adapters from the lead adapter cable (see Section 10.5). The
lead adapter does not need to be disconnected from the lead.
3.
If the lead has been secured to the skin this will need to be released.
4.
Grasp the percutaneous lead between your thumb and forefinger, as close as
possible to the patient’s skin.
5.
Gently withdraw the percutaneous lead from the epidural space.
6.
If the patient is not proceeding straight to implantation surgery then clean the exit
site, close and dress the incision.
Note:
If the patient will proceed to lead and CLS implant surgery:
•
For percutaneous lead implant refer to section 5.2.
9
Revision, Replacement and Explant Surgery
Surgery may be required in case of component failure, movement or site pain.
