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Adverse Events
The following is a list of known risks with the use of deep brain stimulation. There may
be risks that are unknown. Specific adverse events may be more relevant depending on
the indication and site of stimulation. Note that some of these symptoms may be resolved
or reduced by current steering, changing stimulation parameters, or by changing the
position of the Lead during surgery.
If any of these events occur, patients should contact their physician as soon as possible to
inform them.
•
Allergic or immune system response
•
Anesthesia/neurosurgery risks, including unsuccessful implant, exposure to
bloodborne pathogens
•
CSF leak
•
Death, including suicide
•
Embolism, including air embolism and pulmonary embolism
•
Failure or malfunction of any of the device components or the battery, including
but not limited to Lead or Extension breakage, hardware malfunctions, loose
connections, electrical shorts or open circuits and Lead insulation breaches,
whether or not this requires explant and/or reimplantion
•
Hemorrhagic or ischemic stroke, immediate or delayed, which could result in
temporary or permanent neurologic deficits such as muscle weakness, paralysis or
aphasia
•
Implant site complications such as pain, poor healing, wound reopening
•
Infection
•
Injury to tissues adjacent to implant or within surgical field, such as blood vessels,
peripheral nerves, brain (including pneumocephalus), or pleura (including
pneumothorax)
•
Interference from external electromagnetic sources
•
Lead, Extension (including Extension header) and neurostimulator erosion or
migration
•
Loss of adequate stimulation
•
Mentation impairment such as attention or cognitive deficits, memory
disturbances, or confusion
•
Motor problems such as paresis, weakness, incoordination, restlessness, muscle
spasms, postural and gait disorders, tremor, dystonia, or dyskinesias, and falls or
injuries resulting from these problems
•
Musculoskeletal stiffness
•
Neuroleptic malignant syndrome or acute akinesia can occur very rarely
•
Overstimulation or undesirable sensations, such as paresthesia, transient or
persistent
•
Pain, headache or discomfort, transient or persistent, including symptoms due to
neurostimulation
Safety Information
Vercise™ DBS Physician Manual
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