Abbott St. Jude Medical Patient Controller 3875, User Manual

Page: 26 / 108

20
Adverse Effects
The use of a neurostimulation system involves risks.
In addition to those risks commonly associated with
surgery, the following risks are also associated with
use of a neurostimulation system:

Unpleasant sensations or motor disturbances,
including involuntary movement, caused by
stimulation at high outputs (If either occurs, turn
off stimulation 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 implant site

Allergic or rejection response to device or implant
materials