Introduction; Device Description; Compatible Leads And Extensions; Package Contents - Boston Scientific Vercise Gevia 16 Instrucciones De Uso

Introduction

This manual describes the implantation and usage of the rechargeable Vercise Gevia Implantable
Pulse Generator (IPG, also known as the Vercise Gevia Stimulator), and DBS Extensions. The
Stimulator may be implanted immediately following DBS Lead implantation and intra-operative
testing or during a separate surgery.

Device Description

The implantable portion of the Vercise Gevia 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, and a Charger to recharge the battery of the
Stimulator.

Compatible Leads and Extensions

For a list of leads and extensions compatible with the Vercise Gevia DBS System, please see your
DBS Reference Guide.

Package Contents

Vercise Gevia 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.
Introduction
Vercise Gevia™ 16 Contact IPG DFU
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