explosives, or in hazardous locations. If you are unsure of the policy that applies to the use of this device,
please ask for authorization to use it before turning it on.
Consumer goods and electronic devices.
Magnetic interference with consumer goods or electronic devices
that contain magnets, such as mobile phones and smart watches, may unintentionally cause the
neurostimulation system to turn on or turn off or affect communication between the device and generator;
however, it will not change the prescribed programmed parameters. Patients 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 patient is concerned about a smart device interacting with
their neurostimulation system, consider disabling magnet mode. For more information about setting the
magnet mode, refer to the clinician programmer manual or contact Technical Support.
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
▪
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