Instructions For Use; Pre-Conditions; Implanting The Dbs Lead - Boston Scientific DBS Vercise Mode D'emploi

Vercise™ DBS Directional Lead Directions for Use

Instructions for Use

Pre-conditions

The described implant procedures start with implanting the DBS Lead. It is assumed that the following
procedures have been completed:
• The stereotactic frame and/or fiducials of a frameless system are attached to the patient.
• The desired trajectory of the Lead insertion path has been determined.
• The incision in the scalp has been made and the burr hole drilled.
• If using the SureTek™ Burr Hole Cover, the Base of the Burr Hole Cover has been affixed over
the burr hole. (See the manual provided with the Burr Hole Cover Kit for instructions for use.)
• The desired trajectory and Lead depth may have been verified by microelectrode recording or
an appropriate means.

Implanting the DBS Lead

The DBS Directional Lead will be implanted and the therapeutic benefit verified.
1. Prepare the Lead for implant. Visually inspect the Lead and determine it to be acceptable for
implantation.
2. Pass the Lead through the cannula to ensure proper fit.
3. Insert the cannula (with cannula stylet) into the brain to the desired depth.
Note: Cannula depth depends on physician's preference.
4. Assemble the Lead Stop (Figure 1) by partially screwing the threaded portion of the screw into the
threaded hole in the Ring.
5. Measure the desired depth of the Lead with a gauge or ruler and apply the Lead Stop at that length.
To apply the Lead Stop, push the Lead to the center of the Lead Stop and then tighten the Screw
(Figure 2). This will ensure that the Lead will be inserted to the proper depth.
Note: Make sure the Lead Stop will not slide on the Lead when engaged.
Vercise™ DBS Directional Lead
90930938-02 REV A 2 of 247
Figure 1: Lead Stop
Figure 2: Applying the Lead Stop