Adverse Events - Boston Scientific Vercise PC Instrucciones De Uso

Vercise™ PC Information for Prescribers
As an operator of the external devices, you should perform only the following service and
maintenance tasks on the external devices:
• Changing the battery
• Charging the battery
• Cleaning
Ensure that the devices are not in use while performing service and maintenance tasks.

Adverse Events

The following is a list of known risks with the use of deep brain stimulation. Specific adverse events
may be more relevant depending on the indication and site of stimulation. Not all risks are known.
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 reimplantation
• 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
• Psychiatric disturbances such as anxiety, depression, apathy, mania, insomnia, suicide,
or suicidal ideation or attempts
• 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
Vercise™ PC Information for Prescribers
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