NEUROSTAR ADVANCED THERAPY SYSTEM

Additional Manufacturer Narrative

NEUROMETRICS RECEIVED A CALL FROM A PROVIDER REPORTING ONE OF THEIR PATIENTS HAD A SEIZURE DURING THEIR FIRST TREATMENT SESSION. PATIENT HAD HIS MOTOR THRESHOLD DETERMINED SAME DAY. WITHIN 5 MINUTES OF BEGINNING HIS FIRST TREATMENT SESSION, PATIENT REPORTEDLY BEGAN TO HAVE A PANIC ATTACK AND TREATMENT WAS PAUSED. THE PATIENT THEN REPORTEDLY EXPERIENCED A SUDDEN CHANGE IN MENTAL STATUS, HIS "EYE GAZED TO THE RIGHT", AND HAD "TONIC-CLONIC MOVEMENT OF HIS RIGHT ARM ONLY" WHICH LASTED 60-90 SECONDS. EMS WAS CALLED AND PATIENT WAS TAKEN TO THE EMERGENCY ROOM. EMERGENCY ROOM REPORT WAS UNREMARKABLE BUT PATIENT WILL NOT CONTINUE WITH TMS TREATMENT. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF A MOTOR VEHICLE ACCIDENT WHICH MAY HAVE RESULTED IN A POSSIBLE HEAD INJURY WHICH COULD IMPACT THE PATIENT'S SEIZURE THRESHOLD.

Description of Event or Problem

NEUROMETRICS RECEIVED A CALL FROM A PROVIDER'S OFFICE REPORTING ONE OF THEIR PATIENTS EXPERIENCED A SEIZURE DURING THEIR FIRST TREATMENT SESSION. FOLLOWING THE EVENT, PATIENT WAS TAKEN TO THE EMERGENCY ROOM.