Cosman RF Injection Electrodes, Cosman FLEXTRODE Electrode and Cannula, and Cosman RCE – RF Injection Electrode

Prescriptive Information

Indications for Use

The Cosman RF Injection Electrodes, Cosman FLEXTRODE Electrode and Cannula, and Cosman RCE – RF Injection Electrode are used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning of peripheral nerve tissue only. The nerve is localized either by electrical stimulation or by injecting contrast medium through the device and using radiography concomitantly. The nerve may then be blocked by injection of local anesthetic solution or a radiofrequency lesion is made. The CN is used for percutaneous nerve blocks only.

Warnings

For a patient with a cardiac pacemaker, contact the pacemaker company to determine whether the pacemaker needs to be converted to fixed rate pacing during the radiofrequency procedure. When the pacemaker is in the sensing mode, it may interpret the RF signal as a heartbeat and may fail to pace the heart.

Electrodes and probes of monitoring, stimulating, and imaging devices can provide paths for high frequency currents even if they are battery powered, insulated, or isolated at 60 Hz. The risk of burns can be reduced, but not eliminated, by placing the electrodes or probes as far away as possible from the lesion site and from the dispersive electrode. Protective impedances incorporated into the monitoring leads may further reduce the risk of these burns and permit continuous monitoring during energy delivery. Needles should not be used as monitoring electrodes during such procedures. If any physiological monitoring or other electrical apparatus is to be used on the patient simultaneously with this RF generator, the safety aspects of the arrangement should be studied and cleared by a biomedical or clinical engineer.

Do not use a needle as a dispersive electrode, since a needle may cause skin burns at the reference site due to high current densities.

Do not use Magnetic Resonance Imaging (MRI) while the RCE electrode and/or cannula are in place within the patient.

Precautions

Do not use if the Cosman RF Injection Electrode is defective.

Adverse Events

The following adverse events or complications are possible with this procedure: temporary motor deficit and post-operative pain.