Medtronic DBS Mode D'emploi page 22

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– motor coordination and balance disorders: akinesia, "freezing," bradykinesia,
dyskinesia, paresis, asthenia, muscle spasms/rigidity, tremor, loss of balance/
coordination, gait disorder, dizziness, involuntary movements, tics, chorea,
dystonia, facial muscle or limb partial paralysis.
– sensory disturbances: paresthesia, hypoesthesia, burning sensation, headache.
– mentation impairment: attention or cognitive deficits, dysgraphia, memory
disturbances, confusion, somnolence, lethargy.
– sleep disorders: insomnia, abnormal dreams.
– déjà vu.
▪
Psychiatric and behavioral disorders, new or exacerbation of existing symptoms that
might be transient or permanent, including:
– new onset or worsening depression, suicidal ideation, suicide attempt, suicide.
– anxiety, panic, restlessness.
– irritability, anger, aggression, agitation.
– changes or fluctuations in mood, apathy, fatigue.
– other behavioral manifestations: changes in eating behaviors, obsessive-
compulsive disorder, abnormal behavior.
– hyperactivity or euphoria (hypomania).
– psychosis, delusions, hallucinations, delirium, disinhibition, perseveration,
abnormal thinking.
▪
New onset seizures during ongoing therapy
▪
Allergic or immune system response to the implanted materials
▪
Gastrointestinal disturbances
▪
Cough associated with DBS
▪
Transient uncomfortable stimulation (jolting or shocking sensation)
▪
Lack of effective therapy or loss of therapeutic effect
▪
Weight gain or loss
Component disposal
When explanting a device (eg, replacement, cessation of therapy, or postmortem), or
when disposing of accessories, follow these guidelines:
▪
If possible, return the explanted device with completed paperwork to Medtronic for
analysis and disposal. Refer to the back cover for the mailing addresses.
▪
To allow for device analysis, do not autoclave the device or expose the device to
ultrasonic cleaners.
18 English Information for prescribers 2017-05-01