Adverse Effects; Product Description; Package Contents - St.Jude Medical Proclaim Manuel

Therapeutic radiation. Therapeutic radiation may damage the electronic circuitry of an implanted
neurostimulation system, although no testing has been done and no definite information on
radiation effects is available. Sources of therapeutic radiation include therapeutic X rays, cobalt
machines, and linear accelerators. If radiation therapy is required, the area over the implanted
IPG should be shielded with lead. Damage to the system may not be immediately detectable.

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
Persistent pain at the IPG site

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 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.
For more information about IPG features and 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

 1 torque wrench (Model 1101)
 2 port plugs (Model 1111)
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