Adverse Effects; System Overview - Abbott Proclaim 3660 Clinician Manual

Adverse Effects

In addition to those risks commonly associated with surgery, the following risks are associated
with using this neurostimulation system:
Unpleasant sensations or motor disturbances, including involuntary movement, caused by

stimulation at high outputs (If either occurs, turn off your IPG immediately.)
Undesirable changes in stimulation, which may be related to cellular changes in tissue

around the electrodes, changes in electrode position, loose electrical connections, or lead
failure
Stimulation in unwanted places (such as radicular stimulation of the chest wall)

Lead migration, causing changes in stimulation or reduced pain relief

Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from

placement of a lead in the epidural space
Cerebrospinal fluid (CSF) leakage

Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant

Persistent pain at the electrode or 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


System Overview

This neurostimulation system is designed to deliver electrical stimulation to nerve structures. The
neurostimulation system includes the following main components:
Implantable pulse generator (IPG)

Leads

Clinician programmer

Patient controller

Patient magnet

The IPG delivers electrical pulses through the leads to electrodes near selected nerve fibers in
order to provide therapeutic stimulation. The patient magnet can turn the IPG on and off if the
physician enabled this functionality. Physicians use the clinician programmer to create and
modify programs for a patient. Patients use the patient controller to control their prescribed
programs.
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