Adverse Events - Boston Scientific Vercise Mode D'emploi

Adverse Events

The following is a list of known risks with the use of deep brain stimulation. There may be risks that
are unknown. 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 inform their healthcare provider as soon as possible.
• 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
• During an MRI examination, there are potential interactions with the implanted DBS
lead, Extension, and Stimulator, and risk of patient harm. Make sure to follow the
ImageReady™ MRI Guidelines for Boston Scientific DBS Systems, available on the
website www.bostonscientific.com/manuals.
• Musculoskeletal stiffness
• Neuroleptic malignant syndrome or acute akinesia can occur very rarely
• New onset or worsening depression, which may be temporary or permanent, and
suicidal ideations, suicide attempts, and suicide
• Overstimulation or undesirable sensations, such as paresthesia, transient or persistent
• Pain, headache or discomfort, transient or persistent, including symptoms due to
neurostimulation
• Poor initial lead location
Vercise™ Deep Brain Stimulation Systems Information for Prescribers
Safety Information
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