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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. 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.
Report any serious incident that occurs in relation to this device to Boston Scientific and to the
relevant local regulatory authority for medical devices in your country. For customers in Australia,
report any serious incident that occurs in relation to this device to Boston Scientific and to the
Therapeutic Goods Administration (https://www.tga.gov.au).
•
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 Lead 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, Lead Extension (including Lead 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, 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.IFU‑BSCI.com.
•
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
Safety Information
Information for Prescribers
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