Boston Scientific Vercise PC Instrucciones De Uso página 13

• 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
• Poor initial lead location
• Radiation exposure due to imaging (CT, fluoroscopy x-ray)
• Seizures
• Sensory changes
• Seroma, edema or hematoma
• Skin irritation or burns at neurostimulator site
• Speech or swallowing problems such as dysphasia, dysarthria or dysphagia, as well as
complications of dysphagia such as aspiration pneumonia
• Systemic symptoms-autonomic (tachycardia, sweating, increased blood pressure,
flushing, fever, dizziness), changes in renal function, urinary retention, sexual effects,
gastrointestinal (nausea, bowel retention, bloating)
• Thrombosis
• Undesirable sensations such as tingling or generalized warming
• Visual disturbances or periorbital symptoms, such as diplopia, eyelid movement difficulty,
oculomotor difficulties, transient flashes of light or other visual field effects
• Vivid memories
• Weight changes
BS EN 60601-1-2 Classification Information
Testing to demonstrate compliance of the Vercise PC DBS System with the essential requirements
and other relevant provisions of Directive 1999/5/EC were leveraged from testing performed on the
Precision™ SCS System.
• Internally powered
• Continuous operation
• Ordinary equipment
• Class II
Safety Information
Vercise™ PC Information for Prescribers
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