NEUROSTAR ADVANCED THERAPY

Description of Event or Problem

PROVIDER CALLED NEURONETICS TO REPORT THAT ONE OF THEIR PATIENTS EXPERIENCED A SEIZURE DURING HER 5TH TREATMENT SESSION. AN AMBULANCE WAS CALLED AFTER THE EVENT OCCURRED AND THE PATIENT WAS TAKEN TO THE ER.

Additional Manufacturer Narrative

NEURONETICS RECEIVED A CALL FROM A PROVIDER REPORTING ONE OF THEIR PATIENTS EXPERIENCED A SEIZURE DURING THEIR 5TH TREATMENT SESSIONS. WHEN SPEAKING WITH THE PROVIDER REGARDING THE EVENT, THE PROVIDER THEMSELVES DOES NOT BELIEVE THAT THE PATIENT EXPERIENCED AN "ACTUAL SEIZURE". THE PROVIDER BELIEVES THAT THE PATIENT MAY HAVE SUFFERED A "PSEUDO-SEIZURE" AS THE PATIENT REPORTEDLY: WAS ALERT AND ORIENTED FOLLOWING THE EVENT, THERE WAS NO POST-ICTAL STAGE, DID NOT LOOSE CONSCIOUSNESS, AND WAS RESPONSIVE. THE PROVIDER BELIEVES THAT THIS MAY HAVE BEEN CAUSED BY THE INCREASE IN TREATMENT POWER. THE PROVIDER REPORTED THAT THE PATIENT HAS A SMALLER HEAD AND THAT THE INCREASE IN INTENSITY MAY HAVE RESULTED IN THE PATIENT'S MOTOR STRIP BEING STIMULATED. AFTER THE EVENT OCCURRED, THE PATIENT WAS SENT TO THE ER AS A PRECAUTION AND TO BE CHECKED OUT. THE PATIENT REPORTEDLY DID NOT HAVE A FULL WORK UP DONE AT THE ER AND WAS NOT SEEN BY ANY SPECIALIST WHILE THERE. SINCE THE EVENT, THE PATIENT HAS RETURNED TO TMS TREATMENT WITH AN ALTERED PROTOCOL AND HAS NOT HAD ANY ISSUES SINCE.