DEEP TMS SYSTEM

Additional Manufacturer Narrative

THE CAUSES OF THE SEIZURE WERE MULTIFACTORIAL. TRANSGENDER INDIVIDUAL WITH MDD AT INCREASED RISK FOR SUBSTANCE USE, WHICH MAY AFFECT TREATMENT SAFETY AND MEDICATION COMPLIANCE. LEFT HAND MOVEMENT DURING H-7 TREATMENT DURING THE FULL COURSE OF TREATMENT, INDICATING CORTICAL SPREAD OR PRIMING TO THE RIGHT CORTEX AND LOWERING OF MOTOR THRESHOLD, WAS NOT RECOGNIZED AS CORTICAL HYPEREXCITABILITY INDICATOR REQUIRING TREATMENT MODIFICATION. PATIENT WAS TREATED WITH DUAL TREATMENT STIMULATION PROTOCOL, WHICH IS OUTSIDE OF THE APPROVED INSTRUCTIONS FOR USE (I.E., OFF LABEL USE). THIS WAS A DEVICE-INDUCED FOCAL MOTOR SEIZURE (JACKSONIAN SEIZURE) THAT WAS HIGHLY PREVENTABLE THROUGH PROPER RISK ASSESSMENT, PROTOCOL ADHERENCE, AND RECOGNITION OF WARNING SIGNS. MULTIPLE FAILURES CONVERGED TO CREATE AN UNSAFE TREATMENT ENVIRONMENT THAT DIRECTLY CONTRIBUTED TO THIS SERIOUS ADVERSE EVENT.

Description of Event or Problem

PATIENT EXPERIENCED A TONIC-CLONIC SEIZURE DURING SECOND STAGE OF DUAL COIL TREATMENT (H7 - ITBS AND THEN H1 DEPRESSION PROTOCOL, OCCURED DURING TRAIN 34/55 OF DEPRESSION PROTOCOL REATMENT). SEIZURE LASTED APPROXIMATELY 3 MINUTES. POST-ICTAL CONFUSION PRESENT. PATIENT REFUSED TO BE TRANSFERRED TO ER. NO SLEEP DEPRIVATION. THE CAUSES OF THE SEIZURE WERE MULTIFACTORIAL. TRANSGENDER INDIVIDUAL WITH MDD AT INCREASED RISK FOR SUBSTANCE USE, WHICH MAY AFFECT TREATMENT SAFETY AND MEDICATION COMPLIANCE. LEFT HAND MOVEMENT DURING H-7 TREATMENT DURING THE FULL COURSE OF TREATMENT, INDICATING CORTICAL SPREAD OR PRIMING TO THE RIGHT CORTEX AND LOWERING OF MOTOR THRESHOLD, WAS NOT RECOGNIZED AS CORTICAL HYPEREXCITABILITY INDICATOR REQUIRING TREATMENT MODIFICATION. PATIENT WAS TREATED WITH DUAL TREATMENT STIMULATION PROTOCOL, WHICH IS OUTSIDE OF THE APPROVED INSTRUCTIONS FOR USE (I.E., OFF LABEL USE). THIS WAS A DEVICE-INDUCED FOCAL MOTOR SEIZURE (JACKSONIAN SEIZURE) THAT WAS HIGHLY PREVENTABLE THROUGH PROPER RISK ASSESSMENT, PROTOCOL ADHERENCE, AND RECOGNITION OF WARNING SIGNS. MULTIPLE FAILURES CONVERGED TO CREATE AN UNSAFE TREATMENT ENVIRONMENT THAT DIRECTLY CONTRIBUTED TO THIS SERIOUS ADVERSE EVENT.