Adverse Effects; Product Description; Package Contents - St. Jude Medical GII Proclaim Manual De Instrucciones

Adverse Effects

In addition to those risks commonly associated with surgery, the following risks are associated with
implanting or using this IPG:
Unpleasant sensations or motor disturbances, including involuntary movement, caused by

stimulation at high outputs (If either occurs, turn off your IPG immediately.)
Stimulation in unwanted places

Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant
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Persistent pain at the IPG site
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Seroma (mass or swelling) at the IPG site

Allergic or rejection response to implant materials

Implant migration or skin erosion around the implant

 Battery failure

Product Description

This implantable pulse generator (IPG) is an electronic device designed to be connected to one or
more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery
within a titanium case and uses microelectronic circuitry to generate constant-current electrical
stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each
program can provide stimulation to a single anatomical area or to multiple areas. The IPG
communicates wirelessly with system programmers and controllers, and IPGs are available in small
and large sizes to accommodate different power needs.
Some models support additional functions:
Upgradeability. Models can receive software upgrades after implantation to provide patients

with additional features as approved by the respective regulatory agencies. To upgrade features
on the IPG, a system programmer is needed.
Compatible header. Models with a compatible header are designed to allow the IPG to connect

to non-St. Jude Medical leads or extensions that meet the compatibility guidelines.
For more information about which models provide these additional functions, as well as other IPG
specifications, see the appropriate appendix in this manual.
NOTE: For more information about the neurostimulation system, see the clinician's
programming manual for this system.
NOTE: In this document, the term "clinician programmer" refers to the St. Jude Medical™
Clinician Programmer device, "patient controller" refers to the St. Jude Medical Patient
Controller device, "clinician programmer app" refers to the St. Jude Medical Clinician
Programmer software application (app), and "patient controller app" refers to the
St. Jude Medical Patient Controller app.

Package Contents

In addition to the product documentation, the IPG kit contains the following items:
1 IPG (see the appendix in this manual for model numbers)

1 pocket sizer
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 1 torque wrench (Model 1101)
2 port plugs (Model 1111)
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