Boston Scientific Vercise PC Implantable Pulse Generator Manual

92104390-01
Content: 92116333 REV B
Vercise™ PC Implantable
Pulse Generator
Directions for Use
CAUTION: Federal law restricts this device to sale,
distribution and use by or on the order of a physician.

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Trademarks
All trademarks are the property of their respective holders.
Guarantees
Boston Scientic Corporation reserves the right to modify, without prior notice, information relating
to its products in order to improve their reliability or operating capacity.
Additional Information
For indications, contraindications, warnings, precautions, adverse events summary, physician
instructions, sterilization and component disposal, refer to the Information for Prescribers DFU.
For other device-specic information not included in this manual or labeling symbols, refer to the
appropriate DFU as listed on your DBS Reference Guide.
Product Model Numbers
Model Number Description
DB-1140-S Vercise™ PC Implantable Pulse Generator Kit
NM-3138-55 55 cm 8 Contact Extension Kit
DB-4252 and SC-4252 28 cm Straw Tunneling Tool
DB-4254 and SC-4254 35 cm Long Tunneling Tool
Technical Support
There are no user serviceable parts. If you have a specic question or issue, please contact your
sales representative or call (833) DBS-INFO or [phone]).
Radiopaque Identication Tag
The Stimulator contains a radiopaque identication tag that is visible using standard X-ray
procedures.

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Registration of the Vercise PC DBS System
In accordance with international practice and regulatory legislation in some countries, a registration
form is packed with each Boston Scientic Stimulator, DBS Lead, and DBS Extension. The purpose
of this form is to maintain traceability of all products and to secure warranty rights. It also allows the
institution involved in the evaluation or replacement of a specic implanted DBS Lead, accessory,
or device to gain quick access to pertinent data from the manufacturer.
Fill out the registration form included in the package contents. Return one copy to the Boston
Scientic Customer Service Department, keep one copy for patient records, provide one copy to
the patient, and save one copy for the physician.
Boston Scientic
Neuromodulation
Attention: Customer Service Department
25155 Rye Canyon Loop
Valencia, CA 91355, USA

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Table of Contents
Introduction...................................................................................................1
Device Description ............................................................................................... 1
Compatible Leads and Extensions....................................................................... 1
Package Contents................................................................................................ 1
Stimulator Implantation ...............................................................................2
Exposing the DBS Lead ....................................................................................... 2
Connecting the DBS Lead to the DBS Extension................................................. 2
Tunneling the DBS Lead and Extension ............................................................. 4
Connecting the Stimulator.................................................................................... 5
Vercise PC System Revisions, Replacement, and Explantation..............8
Explanting the DBS Lead ..................................................................................... 8
Explanting the DBS Extensions............................................................................ 9
Explanting or Replacing the Stimulator ................................................................ 10
Physical Characteristics of the Vercise PC Stimulator.............................11
Stimulator Programmable Characteristics ................................................11
DBS Extension .............................................................................................14
Tunneling Tool .............................................................................................14

Introduction
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Introduction
This manual describes the implantation and usage of the non-rechargeable Vercise PC implantable
pulse generator, and DBS Extensions. The Stimulator may be implanted immediately following
DBS Lead implantation or during a separate surgery.
Device Description
The implantable portion of the Vercise PC System includes a Stimulator and two DBS Leads.
Other implantable components include the DBS Extensions that extend the DBS Leads to the
Stimulator, a DBS Lead Boot to protect the proximal end of the DBS Lead between surgeries, and
Sutures Sleeves to protect the DBS Lead and/or to anchor the DBS Leads and DBS Extensions.
The Tunneling Tool is a surgical instrument used to create a subcutaneous tunnel for the DBS
Leads and DBS Extensions. The patient will be provided with external devices, including a Remote
Control, to communicate with the Stimulator.
Compatible Leads and Extensions
For a list of leads and extensions compatible with the Vercise PC, please see your DBS Reference
Guide.
Package Contents
Vercise PC Implantable Pulse Generator Kit
• Stimulator
• Stimulator Template
• Stimulator Header Plugs (2)
• Torque Wrench
Note: All contents of the inner package (or tray) are sterile.
Extension Kit (55 cm)
• DBS Extension
• Torque Wrench
• Tunneling Tool Shaft (with Pre-Loaded Straw)
• Tunneling Tool Handle
Note: All contents of the inner package (or tray) are sterile.
Tunneling Tool Kit (28 cm, Straw and 35 cm, Long)
• Tunneling Tool Shaft (with Pre-Loaded Straw)
• Tunneling Tool Handle
Note: All contents of the inner package (or tray) are sterile.

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Stimulator Implantation
Exposing the DBS Lead
1. Palpate the DBS Lead Boot and DBS Lead under the scalp.
2. Mark and create an incision in the scalp to expose the Lead Boot. Be careful not to damage or
cut the DBS Lead.
3. Expose the DBS Lead and Lead Boot through the incision.
4. Using the Torque Wrench, remove and discard the Lead Boot.
Note: To loosen the setscrew, rotate the Torque Wrench counterclockwise. To tighten the
setscrew, rotate the Torque Wrench clockwise.
5. Dry the proximal end of the DBS Lead.
Connecting the DBS Lead to the DBS Extension
Setscrew
DBS Extension DBS Lead
1. Check to ensure that the Setscrew is not restricting the entry port on the DBS Extension
connector by unscrewing the Setscrew one to two turns with the Torque Wrench. Grip the DBS
Lead next to the Retention Sleeve.
Contacts Retention
Sleeve
Proximal End of the DBS Lead
DBS Lead
Note: The retention sleeve is easily distinguishable from the contacts by its extended
length.
2. Push the DBS Lead into the DBS Extension connector until the DBS Lead electrodes line up
with the DBS Extension contacts. Some resistance may be felt as each electrode enters into
the DBS Extension Connector. You should be able view the DBS Lead electrodes as they pass
through the DBS Extension Connector. Some additional resistance may be felt as the last
electrode aligns into place.

Stimulator Implantation
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3. Visually check to ensure that the DBS Lead electrodes are aligned with the DBS Extension
contacts. If they are not aligned, continue to grip the DBS Lead next to the Retention Sleeve
and push to advance the electrodes into alignment with the DBS Extension contacts. If
necessary, back out the lead slightly and then advance the electrodes into alignment again,
until proper alignment can be conrmed.
Note: Be sure to fully insert the DBS Lead into the connector so that the retention sleeve
is located under the setscrew.
Correct Incorrect
4. Do not tighten the Setscrew at this time.
5. Repeat steps 1 through 3 to connect the second DBS Lead to the second DBS Extension.
6. Test the impedance of the connection to ensure that you have properly aligned the DBS Lead
within the DBS Extension connector. See “Intraoperative Testing” in the appropriate lead
implant DFU as listed on your DBS Reference Guide.
Assembling the Tunneling Tool
A Tunneling Tool and Straw are provided to facilitate tunneling of the DBS Extension.
Tool Handle
Shaft
1. Attach the Tunneling Tool Handle to the Shaft by turning the locking mechanism clockwise.
a. Push the locking mechanism at the base of the Tool Handle onto the Shaft.
b. Grasping the Tool Handle and the Tip of the Tunneling Tool, rotate the Shaft back and forth
until the handle seats onto the Shaft.
c. While rmly grasping the Tip of the Tunneling Tool to hold the Shaft stationery, turn the
locking mechanism clockwise until secure.

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Tunneling the DBS Lead and Extension
1. Create a pocket for the Stimulator under the skin in a location inferior to the clavicle on the
same side as the DBS Lead and Extensions.
Note: Boston Scientic recommends implanting the Stimulator subclavicularly.
a. Mark the location of the pocket.
b. Use the template to outline the intended pocket to guide the optimal pocket sizing.
Note: It is important to keep the pocket small to prevent the Stimulator from turning over.
2. Mark a tunneling route from the location of the subclavicular pocket to the incision superior to
the ear.
3. Administer appropriate local anesthetic along the tunneling route.
CAUTION: Be sure not to puncture or damage the Lead or other components when
administering local anesthetic.
4. Create a subcutaneous tunnel from the incision above the ear, along the tunneling path to the
Stimulator pocket.
WARNING: Be careful not to puncture or damage important structures along the tunneling
path, such as the brachial plexus and jugular, as this may cause patient harm.
5. If desired, bend the Tunneling Tool to an appropriate shape.
CAUTION: Do not bend locking joints.
6. Once the Tip of the Tunneling Tool is completely exposed, unscrew and remove the Tunneling
Tool Handle.
7. Grasp the Tip rmly with one hand and, while holding the Straw in place with the other hand,
pull the Shaft out of the Straw.
8. Push the proximal ends of the DBS Extensions through the Straw, and then withdraw the Straw.
9. Optionally secure the DBS Extension connector to the fascia using sutures and/or suture
sleeves.

Stimulator Implantation
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CAUTION: Do not use polypropylene sutures as they may damage the suture sleeve. Do not
suture directly onto the DBS Extension or use a hemostat on the DBS Extension
body. This may damage the DBS Extension insulation.
Connecting the Stimulator
Dual Lead Connection
Connect Left DBS Extension to port C Connect Right DBS Extension to port D
1. Fully insert the male end of the DBS Extension into the Stimulator until it stops.
a. Insert the header plug to verify no Setscrews obstruct the socket.
b. Wipe the DBS Extension contacts before inserting.
c. Insert the DBS Extensions into the header. When fully inserted, the tip of the DBS
Extension will slide into the back of the port and the retention sleeve on the DBS Extension
will be located under the Setscrew.
CAUTION: Verify proper DBS Extension insertion by checking impedances before tightening
the Setscrew. Tightening the Setscrew down onto a contact can damage the
DBS Extension.

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2. Verify that the retention sleeve on the DBS Extension is located directly under the Setscrew in
the Stimulator header.
Note: The retention sleeve is easily distinguishable from the contacts by its length (see
below).
Contacts Retention
Sleeve
Proximal End of the DBS Extension
3. Check impedances to verify connections before tightening the Setscrew.
a. Place the Stimulator partially in the subcutaneous pocket.
b. Test impedances using the Remote Control or Clinician Programmer.
4. Pass the Torque Wrench through the slit in the septum located on the side of the Stimulator
header.
5. Tighten the Setscrew in the Stimulator until the Torque Wrench clicks, indicating the Setscrew
is fully secured.
Note: To tighten the Setscrew, rotate the Torque Wrench clockwise. To loosen the
Setscrew, rotate the Torque Wrench counterclockwise.