Abbott 3599 - Adverse Effects; Stimulation-Related Effects

explosives, or in hazardous locaons. If you are unsure of the policy that applies to the use of this device,
please ask for authorizaon to use it before turning it on.
Consumer goods and electronic devices. Magnec interference with consumer goods or electronic devices
that contain magnets, such as mobile phones and smart watches, may unintenonally cause the
neurosmulaon system to turn on or turn o or aect communicaon between the device and generator;
however, it will not change the prescribed programmed parameters. Paents should be advised to keep
their mobile phones and smart watches at least 15 cm (6 in.) away from the generator and avoid placing any
smart device in a pocket near the generator. If a paent is concerned about a smart device interacng with
their neurosmulaon system, consider disabling magnet mode. For more informaon about seng the
magnet mode, refer to the clinician programmer manual or contact Technical Support.
Adverse Eects
The use of a neurosmulaon system involves risks. In addion to those risks commonly associated with
surgery, the following risks are also associated with use of a neurosmulaon system:
▪
Unpleasant sensaons or motor disturbances, including involuntary movement, caused by smulaon
▪
at high outputs (If either occurs, turn o smulaon immediately.)
▪
Undesirable changes in smulaon, which may be related to cellular changes in ssue around the
▪
electrodes, changes in electrode posion, loose electrical connecons, or lead failure
▪
Smulaon in unwanted places (such as radicular smulaon of the chest wall)
▪
▪ Lead migraon, causing changes in smulaon or reduced pain relief▪
▪
Epidural hemorrhage, hematoma, infecon, spinal cord compression, or paralysis from placement of a
▪
lead in the epidural space
▪
Cerebrospinal uid (CSF) leakage
▪
7