DEEP TRANSCRANIAL MAGNETIC STIMULATOR

Additional Manufacturer Narrative

AFTER INTERNAL MEDICAL REVIEW, THE SEIZURE IS LIKELY ASSOCIATED WITH A GENETIC PREDISPOSITION FOR SEIZURES AND A HIGH MOTOR THRESHOLD. ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE - THE DEVICE SHOULD NOT HAVE BEEN USED ON A PATIENT WITH A FIRST DEGREE RELATIVE WITH A HISTORY SEIZURES. THE COMPANY'S MEDICAL AFFAIRS TEAM HAD A DISCUSSION WITH THE PROVIDER TO DISCUSS THE EVENT AND PROVIDE FURTHER EDUCATION AND AWARENESS SURROUNDING BEST PRACTICES FOR MOTOR THRESHOLD PROCEDURES AND THE INFLUENCE OF FAMILY HISTORY OF SEIZURES ON A PATIENT'S PROPENSITY FOR THIS TYPE OF EVENT.

Description of Event or Problem

39 YEAR OLD PATIENT WITH MDD HAS A SEIZURE DURING TMS TREATMENT SESSION #23. PATIENT WAS UNRESPONSIVE FOR APPROXIMATELY 12 SECONDS, LOST BLADDER CONTROL AND VOMITED. PATIENT WAS POST ICTAL FOR APPROXIMATELY 25 MINUTES. PATIENT WAS EVALUATED IN THE ER AND RELEASED FOLLOWING NO ABNORMAL FINDINGS ON CT. THE ONLY REMARKABLE FINDINGS FROM ER WAS A UTI. THE PATIENT HAS A FATHER AND BROTHER WITH A HISTORY SEIZURES. FURTHERMORE, THE PATIENT'S MOTOR THRESHOLD WAS RELATIVELY HIGH. CONSEQUENTLY, AFTER INTERNAL MEDICAL REVIEW, THE SEIZURE IS LIKELY ASSOCIATED WITH A GENETIC PREDISPOSITION FOR SEIZURES AND A HIGH MOTOR THRESHOLD.