DEEP TMS SYSTEM

Description of Event or Problem

PATIENT EXPERIENCED A TONIC-CLONIC SEIZURE DURING TREATMENT SESSION #34 SEIZURE WAS RESOLVED WITHIN 45 SECONDS AND PATIENT WAS ABLE TO RESPOND WITHIN 2 MINUTES. PATIENT REFUSED TO BE TRANSFERRED TO ER. NO SEIZURE HISTORY OR FAMILY SEIZURE HISTORY AND NO SLEEP DEPRIVATION. THE CAUSES OF THE SEIZURE WERE MULTIFACTORIAL, INCLUDING THAT THE PATIENT WAS WITHDRAWING FROM NITROUS OXIDE SUBSTANCE ABUSE. ADDITIONALLY, PATIENT WAS IN A DRUG RECOVERY PROGRAM FOR ALCOHOL USE DISORDER. AND THE DEVICE WAS BEING USED OFF LABEL AND NOT IN ACCORDANCE WITH THE MANUFACTURER'S INSTRUCTIONS FOR USE (I.E., THE INTER-TRAIN INTERVAL WAS SHORTENED TO 12 SECONDS (INSTEAD OF 20 SECONDS) AND THE PATIENT WAS RECEIVING TREATMENT WITH THE H1 AND H7 COILS DURING THE SAME TREATMENT SESSION). FURTHERMORE, THE PATIENT WAS ON WELLBUTRIN XL WHICH HAS AN INCREASED RISK FOR SEIZURES.

Additional Manufacturer Narrative

THE CAUSES OF THE SEIZURE WERE MULTIFACTORIAL, INCLUDING THAT THE PATIENT WAS WITHDRAWING FROM NITROUS OXIDE SUBSTANCE ABUSE. ADDITIONALLY, PATIENT WAS IN A DRUG RECOVERY PROGRAM FOR ALCOHOL USE DISORDER. AND THE DEVICE WAS BEING USED OFF LABEL AND NOT IN ACCORDANCE WITH THE MANUFACTURER'S INSTRUCTIONS FOR USE (I.E., THE INTER-TRAIN INTERVAL WAS SHORTENED TO 12 SECONDS (INSTEAD OF 20 SECONDS) AND THE PATIENT WAS RECEIVING TREATMENT WITH THE H1 AND H7 COILS DURING THE COURSE OF THE TREATMENTS). FURTHERMORE, THE PATIENT WAS ON WELLBUTRIN XL WHICH HAS AN INCREASED RISK FOR SEIZURES.