NEUROSTAR ADVANCED THERAPY SYSTEM

Description of Event or Problem

NEURONETICS WAS CONTACTED BY A PROVIDER REPORTING THAT ONE OF THEIR PATIENTS HAD A SEIZURE AFTER COMPLETING HIS FIRST THETA BURST TREATMENT SESSION. EMS WAS CALLED AND THE PATIENT WAS SENT TO THE EMERGENCY ROOM.

Additional Manufacturer Narrative

NEURONETICS RECEIVED A CALL FROM A PROVIDER REPORTING THAT ONE OF THEIR PATIENTS HAD A SEIZURE AFTER COMPLETING THEIR FIRST THETA BURST SESSION. PATIENT WAS MAPPED ON THE SAME DAY AND PROVIDER REPORTED THAT PATIENT HAD A "TOUGH MAPPING" WHERE IT WAS DIFFICULT TO LOCATE THE PATIENT'S THUMB MOVEMENT. DURING THE TREATMENT SESSION PATIENT DID REPORT THAT THE PULSING FELT UNCOMFORTABLE BUT OTHERWISE TOLERATED TREATMENT WELL. TOWARD THE END OF THE TREATMENT, PATIENT NOTED THAT HE WAS EXPERIENCING "SHORTNESS OF BREATH". AFTER THE TREATMENT WAS FINISHED, PATIENT WAS GETTING UP FROM THE CHAIR AND HAD A SEIZURE THAT LASTED ABOUT 15-30 SECONDS. PATIENT REPORTEDLY RECOVERED VERY QUICKLY AT THE OFFICE WITH NO MEMORY LOSS BUT EMS WAS CALLED AND PATIENT WAS SENT TO THE EMERGENCY ROOM AS A PRECAUTION. PATIENT WAS DISCHARGED FROM THE EMERGENCY ROOM WITHIN AN HOUR. PATIENT IS CURRENTLY ON SEVERAL MEDICATIONS THAT COULD POTENTIALLY IMPACT HIS SEIZURE THRESHOLD INCLUDING ABILIFY, TRILEPTAL, AND SPRAVATO SINCE JULY OF THIS YEAR. THE PROVIDER REPORTED THAT THE PATIENT'S LAST DOSE OF SPRAVATO WAS THE DAY BEFORE HE RECEIVED HIS FIRST TREATMENT SESSION. PROVIDER ALSO NOTED THAT THE PATIENT IS "RESTLESS" AT NIGHT OFTEN WAKING UP "WITH THE BED TORN" BUT IS REPORTEDLY ABLE TO SLEEP THROUGH THE NIGHT. THE PROVIDER WANTS PATIENT TO BE SEEN BY NEUROLOGY TO RULE OUT ANY UNDERLYING ISSUES PRESENT. PATIENT WILL NOT BE CONTINUING WITH TMS THERAPY.