NEUROSTAR ADVANCED THERAPY

Description of Event or Problem

NEURONETICS RECEIVED A CALL FROM A PROVIDER REPORTING THAT ONE OF THEIR PATIENTS EXPERIENCED A SEIZURE DURING THEIR 9TH TREATMENT SESSION AND WAS TAKEN TO THE EMERGENCY ROOM.

Additional Manufacturer Narrative

TMS PROVIDER REPORTED TO NEURONETICS THAT A PATIENT WAS EXPERIENCING EYE PAIN/DISCOMFORT AND HAND/ARM MOVEMENT DURING TREATMENT. THE TREATER REPORTEDLY ATTEMPTED TO ALLEVIATE THE PATIENT'S DISCOMFORT AND HAND/ARM MOVEMENT IN A MANNER WHICH IS NOT RECOMMENDED BY NEURONETICS. AFTER MAKING THE ADJUSTMENTS, THE PATIENT "ARCHED HIS BACK" AND ALLEGEDLY HAD A SEIZURE. THE SEIZURE ALLEGEDLY LASTED 3-4 MINUTES AND THE PATIENT WAS TAKEN TO THE ER. PATIENT HAS REPORTEDLY EXPERIENCED "CONVULSIONS" DUE TO PAST MEDICATIONS THOUGH HE HAS NOT BEEN DIAGNOSED WITH A SEIZURE DISORDER. PATIENT IS CURRENTLY ON SEVERAL MEDICATIONS THAT MAY INFLUENCE THE SEIZURE THRESHOLD (PRISTIQ, DEPAKOTE, SEROQUEL, FIORICET). IT WAS NOTED THAT THE PATIENT HAS BEEN HAVING DIFFICULTY OBTAINING SEVERAL OF HIS MEDICATIONS AND MAY NOT HAVE BEEN TAKING THEM CONSISTENTLY WHICH MAY HAVE ALSO INFLUENCED THE SEIZURE THRESHOLD. PATIENT HAS STOPPED TREATMENT AND IS SCHEDULED TO SEE A NEUROLOGIST FOR FOLLOW UP.