Adverse Events - Boston Scientific Vercise Gevia Instrucciones De Uso

Vercise Gevia™ Information for Prescribers
Cleaning the Remote Control, External Trial Stimulator, Charger, Base
Station, Power Supply and Programming Wand. The components can be cleaned
using alcohol or a mild detergent applied with a cloth or tissue. Residue from soapy detergents
should be removed with a damp cloth. Do not use abrasive cleansers for cleaning. Do not clean
any of the accessories while they are directly or indirectly connected to a power outlet.
Cleaning the Charging Collar. Hand wash the Charging Collar with mild soap and warm
water. Do not machine wash the charging collar. Let the Charging Collar air dry. Be sure to remove
the Charger and Counterweight from the Charging Collar before washing the Charging Collar.

Adverse Events

The following is a list of known risks with the use of deep brain 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 inform their physician 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
• Musculoskeletal stiffness
Vercise Gevia™ Information for Prescribers
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