DEEP TRANSCRANIAL MAGNETIC STIMULATION (DEEP TMS)

Additional Manufacturer Narrative

THE CAUSES OF THE SEIZURE WERE MULTIFACTORIAL, INCLUDING SEVERE SLEEP DEPRIVATION, LIKELY ALCOHOL WITHDRAWAL, COMBINED WITH MULTIPLE HIGH-INTENSITY OFF-LABEL STIMULATION PROTOCOLS AND PALM PAIN PRIOR TO SEIZURE NOT RECOGNIZED AS SEIZURE PRODROME. THE EVENT WAS PREVENTABLE BY PROPER RISK ASSESSMENT, PROTOCOL ADHERENCE, AND RECOGNITION OF WARNING SIGNS.

Description of Event or Problem

PATIENT EXPERIENCED A GENERALIZED TONIC-CLONIC SEIZURE AFTER RECEIVING SEVERAL CONSECUTIVE TREATMENT STIMULATION PROTOCOLS (18HZ STANDARD OF CARE HIGH FREQUENCY STIMULATION PROTOCOL, FOLLOWED BY ITBS STIMULATION PROTOCOL, FOLLOWED BY ANXIETY ITBS). SEIZURE LASTED APPROXIMATELY 10 MINUTES, WITH EXTENDED BACK AND NECK POSITION AND LABORED BREATHING. NO URINATION DURING EVENT. PATIENT TRANSFERRED TO ER. SEVERE SLEEP DEPRIVATION NIGHT BEFORE TREATMENT. PALM PAIN PRIOR TO SEIZURE NOT RECOGNIZED AS SEIZURE PRODROME. OFF-LABEL USE OF NON-FDA APPROVED TREATMENT STIMULATION PROTOCOLS AND COMBINATIONS OF THESE. THIS WAS A HIGHLY PREVENTABLE TMS-INDUCED GENERALIZED TONIC-CLONIC SEIZURE RESULTING FROM SIGNIFICANT DEVIATION FROM FDA-APPROVED INSTRUCTIONS FOR USE. THE PRIMARY CONTRIBUTING FACTOR WAS SEVERE SLEEP DEPRIVATION (2 HOURS), LIKELY ALCOHOL WITHDRAWAL, COMBINED WITH MULTIPLE HIGH-INTENSITY PROTOCOLS THAT EXCEEDED ESTABLISHED SAFETY PARAMETERS. COMPREHENSIVE EMERGENCY ROOM EVALUATION INCLUDING CT HEAD, LABORATORY STUDIES, AND NEUROLOGIST CONSULTATION RULED OUT ALTERNATIVE SEIZURE ETIOLOGIES, ESTABLISHING THIS AS A DEVICE-INDUCED SEIZURE. THE IFU EXPLICITLY LISTS SLEEP DEPRIVATION AS A SEIZURE RISK FACTOR REQUIRING CAUTION, AND MULTIPLE TMS STUDIES DEMONSTRATE THAT SLEEP DEPRIVATION INCREASES CORTICAL EXCITABILITY AND REDUCES INTRACORTICAL INHIBITION, THEREBY LOWERING SEIZURE THRESHOLD. THE USE OF THREE CONSECUTIVE HIGH-INTENSITY PROTOCOLS REPRESENTS TREATMENT OUTSIDE FDA-APPROVED PARAMETERS WHERE SAFETY AND EFFICACY HAVE NOT BEEN ESTABLISHED. ENHANCED PRE-TREATMENT SCREENING PROTOCOLS, PARTICULARLY FOR SLEEP ASSESSMENT AND IFU COMPLIANCE, COULD HAVE PREVENTED THIS SERIOUS ADVERSE EVENT.