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A subset of Kinetra implantable neurostimulators may experience a failure of wire connections between the electronic hybrid circuit and battery which may lead to sudden cessation of therapy. Sudden cessation of therapy can result in the immediate return or worsening of underlying symptoms due to the progression of the disease state.
Enpath Lead Adapters: The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degress of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device.
The internal component (Connector Block) of the Lead Adapter used to secure a lead to the adapter has exhibited varying degress of radial cracks that could cause a temporary intermittent electrical signal disruption if lateral tension is applied to device.