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Safety Information
Safety Information
Intended Use
The Vercise™ Adapter M8 is intended to connect compatible Medtronic Lead Extensions to the
compatible Boston Scientific Implantable Pulse Generator (IPG).
Cautions
Clinical data for the use of the Vercise Adapter M8 in the treatment of intractable primary/secondary
dystonia and Essential Tremor is still being collected.
Do not bend, kink, or stretch the Lead Extension or Vercise Adapter M8; this may break its wires
or connections. Broken wires or connections may create an open circuit, resulting in component
failure, loss of stimulation, and potential surgical intervention.
Do not handle the Vercise Adapter M8 with instruments that were not supplied with the Adapter.
Other instruments may cause damage to the device, including broken wires or connections.
The Setscrew in the Vercise Adapter M8 must be retracted to insert the Lead Extension. There is
no stop feature to prevent excessive retraction of the Setscrew and disassembly of the Adapter. To
avoid damage to the sealing grommet, do not retract the Setscrew assembly more than is needed
to insert the Lead Extension.
Minimize the number of Hex Wrench insertions into the Vercise Adapter M8 to prevent damage to
the septum seal plug.
Instructions for Use
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