NEUROSTAR ADVANCED THERAPY

Description of Event or Problem

NEURONETICS RECEIVED A CALL FROM A PROVIDER STATING THAT ONE OF THEIR PATIENTS HAD EXPERIENCED A SEIZURE DURING THEIR 30TH TREATMENT SESSION AND WAS SUBSEQUENTLY TAKEN TO THE EMERGENCY ROOM.

Additional Manufacturer Narrative

PROVIDER CALLED TO REPORT THAT ONE OF THEIR PATIENTS EXPERIENCED A SEIZURE LASTING 2 MINUTES DURING THEIR 30TH TREATMENT SESSION AND WAS TAKEN TO THE ER. PATIENT HAD TOLERATED ALL PREVIOUS TREATMENT SESSIONS WELL PRIOR TO THE EVENT. PATIENT HAD BEEN RECEIVING AN OFF LABEL BILATERAL PROTOCOL FOR TREATMENT. PATIENT HAD HER MT REMAPPED HALFWAY THROUGH THE COURSE OF TREATMENT, AS IS STANDARD PROTOCOL FOR THE OFFICE PER PROVIDER, AND HER TREATMENT LOCATION SHIFTED AS A RESULT. PATIENT REPORTEDLY PREVIOUSLY SUFFERED A FALL FROM HORSEBACK RIDING WHICH REQUIRED HER TO BE TAKEN TO THE HOSPITAL THOUGH IT IS UNKNOWN WHAT INJURY SHE HAD SUFFERED AS A RESULT. PATIENT IS CURRENTLY ON AN ANTIDEPRESSANT WHICH COULD LOWER HER SEIZURE THRESHOLD. A WEEK BEFORE THE EVENT, THE PATIENT WAS SICK AND TOOK A FEW DAYS OFF TREATMENT AND REPORTEDLY HAD BEEN SLEEPING A LOT, WHICH MAY HAVE IMPACTED HER SEIZURE THRESHOLD. PATIENT HAS REPORTEDLY RECOVERED WELL POST THE EVENT AND HAS NOT HAD ANY SEQUELAE.