Indications for Use
The TC Electrode is indicated for use in radiofrequency (RF) heat lesioning of non-central nervous system nerve tissue.
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 if the Boston Scientific RF Electrode is defective.
Do not interchange components from different electrode kits. Using the wrong component can result in serious patient injury.
The following adverse events or complications are possible with this procedure: hemianesthesia, limb dystonia, worsening dysarthria, dysphasia, cerebral infarction, intracerebral hematoma, oculomotor palsy, hemiballismus, persistent hemiparesis, persistent gait disturbance, persistent numbness, seizure, transient monoparesis or facial palsy, homonymous hemianopsia, worsening of balance, worsening of depression, acute confusion, personality change, cognitive disorder, worsening of dementia, weight gain, and/or death.