Medtronic DBS Mode D'emploi page 19

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may be adversely affected, resulting in inaccurate ECG results. Inaccurate ECG results
may lead to inappropriate treatment of the patient.
Home or occupational environment
Home or occupational environment - Medtronic DBS Neurostimulators should not be
affected by normal operation of electrical equipment such as household appliances,
electric machine shop tools, microwave ovens, RF transmitting systems, or microwave
frequency transmitting systems. A strong magnetic field (electromagnet or permanent
magnet) can switch the neurostimulator output from on to off or off to on, but does not
change the programmed parameters.
Advise your patients to avoid or to exercise care when approaching the following:
▪
Theft detectors
▪
Airport/security screening devices
▪
Large stereo speakers with magnets
▪
Electric arc welding equipment
▪
Electric steel furnaces
▪
Electric induction heaters (used in industry to bend plastic)
▪
Power lines
▪
Electric substations and power generators
If your patient suspects an electrical device or magnet is interfering with the
neurostimulator, advise him/her to move away from it, or turn the device off. Then, the
patient can use the patient control device to set the neurostimulator back to the desired
on or off state. When switched on, the neurostimulator will resume stimulation at the
previously programmed level.
Radio-frequency sources - Analog and digital cellular phones, AM/FM radios, cordless
phones, and conventional wired telephones may contain permanent magnets. To prevent
undesired turning on or off of the stimulation, these devices should be kept at least 10 cm
(4 in) away from the implanted neurostimulator.
Adverse events
The following adverse events may occur with DBS therapy. Specific adverse events or
groups of adverse events may be more relevant depending on the patient indication and
site of stimulation. For additional indication-specific adverse events, see the appropriate
indication-specific IFP addendum.
Risks (potential adverse events) related to the lead, extension, or neurostimulator
implant, explant, or revision procedures:
▪
Immediate intracranial hemorrhage or cerebral infarction which could be
symptomatic, or which could result in temporary or permanent neurological injury or
death
▪
Asymptomatic intracerebral hemorrhage or ischemia related to the DBS lead implant
identified through postoperative imaging
16 English Information for prescribers 2017-05-01