Electrodes Implantable with Adapter

FDA-Cleared Indications

• Interfacing with neuron-motor pathways for electrical stimulation.
• Use as part of an implantable electrode system with an adapter.

Clinical Applications

• Implantable electrical stimulation involving neuron-motor pathways.
• Use with compatible implanted stimulation equipment when specified by the device labeling.
• Use in procedures requiring an implanted electrode and adapter interface.

Reported off-label uses

• Deep brain stimulation or other neuromodulation applications may have been described for similar electrode systems, but these uses should not be assumed to be covered by this historical FDA record without confirming the original labeling.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• Confirm compatibility between the electrode, adapter, pulse generator, leads and any other implanted components before use.
• The available record does not provide electrode dimensions, contact configuration, lead length or adapter specifications; consult the original manufacturer documentation.
• MRI safety is not established by the information provided. Do not assume the system is MRI safe or MRI conditional without device-specific labeling.
• Assess for infection, tissue injury, bleeding and device malfunction as with other implanted stimulation systems.
• This is a historical Class III device record from 1978; verify current availability, labeling and regulatory status before clinical use.