NEUROSTAR ADVANCED THERAPY

Description of Event or Problem

PATIENT EXPERIENCED A SEIZURE DURING HER 14TH TMS TREATMENT. SHE HAD RECEIVED 27 MINUTES/ 2400 PULSES WHEN SEIZURE ACTIVITY WAS NOTICED. TREATMENT STOPPED AND EMS CALLED.

Additional Manufacturer Narrative

PATIENT WAS NOT TREATED WITH THE FULL TREATMENT DOSE PERCENTAGE FOR THE PROTOCOL. PATIENT HAS A HISTORY OF SEIZURES AS A CHILD WHICH WAS NOT PROPERLY DISCLOSED, AND SHE HAD NOT BEEN SLEEPING WELL PRIOR THE SEIZURE WHICH COULD CONTRIBUTE TO THE SEIZURE RISK. PATIENT ON TWO MEDICATIONS THAT COULD AFFECT SEIZURE THRESHOLD IF NOT TAKEN AS SCHEDULED, BUT IT IS NOT KNOWN WHETHER THE PATIENT MISSED ANY DOSES.