DEEP TMS SYSTEM

Additional Manufacturer Narrative

THE EVENT COULD HAVE BEEN CAUSED BY A COMBINATION OF FACTORS INCLUDING OPERATOR ERROR AND HIGH DOSE CLOMIPRAMINE.

Description of Event or Problem

REPORT OF SEIZURE OR PSEUDO-SEIZURE OR COMPLEX SYNCOPE IN AN 18-YEAR-OLD MALE WITH OCD AND ANXIETY. THE DEVICE TECHNICIAN REPORTED JERKING MOVEMENTS, AND THE PA NOTED "TONIC-CLONIC" MOVEMENTS. THE PHYSICIAN STATED THAT WHEN HE ENTERED THE ROOM THE MOVEMENTS HAD RESOLVED, AND THE PATIENT WAS WELL ORIENTED AND REMEMBERED THE DETAILS OF THE EVENTS WITH NO CONFUSION. NO BOWEL OR BLADDER INCONTINENCE AND NO TONGUE OR GUM LESIONS WERE OBSERVED. CONSEQUENTLY, IT IS NOT CLEAR IF THIS WAS A SEIZURE OR PSEUDO-SEIZURE OR COMPLEX SYNCOPE. THE EVENT OCCURRED 16 MINUTES INTO TREATMENT NUMBER 22, IN A SUBJECT WITH NO SEIZURE HISTORY AND NO FAMILY SEIZURE HISTORY. PATIENT DENIED DRUG, ALCOHOL USE, HISTORY OF SUDS OR NEUROLOGICAL DISORDERS AND NO FEVERS. TMS TREATMENT WAS STOPPED. THE PATIENT WAS ON HIGH DOSE CLOMIPRAMINE (200-300 MG QD). THE DEVICE WAS ALSO USED OFF-LABEL IN A PATIENT UNDER THE AGE OF 22 YEARS. ADDITIONALLY, THE MOTOR THRESHOLD (MT) WAS 1.5 CM OFF CENTER MT AS WELL AS THE TREATMENT LOCATION, WHICH IS NOT THE CORRECT TREATMENT LOCATION. RECOMMENDED THAT THE PATIENT BE WORKED UP BY A NEUROLOGIST GIVEN THE POSSIBILITY THAT THIS COULD BE A SEIZURE, AND THAT THE PHYSICIAN AND OPERATOR REVIEW THE TRAINING MATERIALS ON MY BRAINSWAY.COM AS THE PATIENT WAS TREATED OFF-LABEL AND IN THE INCORRECT TREATMENT LOCATION. THE EVENT COULD HAVE BEEN CAUSED BY A COMBINATION OF FACTORS INCLUDING USER ERROR AND HIGH DOSE CLOMIPRAMINE.