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Long-term safety and effectiveness. The long-term
safety and effectiveness of this neurostimulation
system has not been established beyond 5 years.
Safety and effectiveness has not been established for
patients with neurological disease other than
Parkinson’s disease or essential tremor, previous
surgical ablation procedures, dementia,
coagulopathies, or moderate to severe depression;
patients under 22 years; implantation in targets other
than STN or GPi for Parkinson's disease and VIM for
essential tremor; patients with an active implantable
device; patients requiring MRI.
Handling and Implantation
Component manipulation. Do not rub or press on
implanted components through the skin. This may
cause the leads to move leading to stimulation at the
implant site, IPG inversion leading to the inability to
communicate with the device, or skin erosion that can
lead to another surgical procedure or possible
infection.
Abandoned leads. The long-term safety associated
with multiple implants, leads left in place without use,
replacement of leads, multiple implants into the target
structure, and lead explant is unknown.
