BRAINSWAY DEEP TMS SYSTEM

Additional Manufacturer Narrative

CONTRIBUTING FACTORS ANALYSIS: PATIENT-RELATED RISK FACTORS: MEDICATION: PATIENT PRESCRIBED VYVANSE (LISDEXAMFETAMINE), WHICH IS KNOWN TO LOWER SEIZURE THRESHOLD. SUBSTANCE USE: POSITIVE DRUG SCREEN FOR THC (MARIJUANA), WHICH MAY AFFECT SEIZURE SUSCEPTIBILITY. ADDITIONAL UNDISCLOSED SUBSTANCE USE CANNOT BE RULED OUT AND MAY HAVE FURTHER CONTRIBUTED TO SEIZURE RISK. POTENTIAL ALCOHOL USE: STAFF REPORTED PATIENT WAS KNOWN TO "PARTY" AND MAY HAVE CONSUMED ALCOHOL DESPITE DENIAL, THOUGH THIS REMAINS UNCONFIRMED. DEVICE/PROCEDURAL FACTORS: EQUIPMENT ADJUSTMENTS: HELMET POSITIONING AND TREATMENT LOCATION MODIFICATIONS WERE MADE DURING THE SESSION IN RESPONSE TO PATIENT DISCOMFORT. MOTOR THRESHOLD COMPLIANCE: MOTOR THRESHOLD (MT) WAS NOT BEING RECHECKED WEEKLY AS REQUIRED BY MANUFACTURER GUIDELINES, POTENTIALLY RESULTING IN INAPPROPRIATE TREATMENT PARAMETERS. PATIENT MONITORING: TECHNICIAN WAS WORKING ON A COMPUTER WITH BACK TURNED TO THE PATIENT WHEN THE SEIZURE OCCURRED, REPRESENTING A SIGNIFICANT DEVIATION FROM REQUIRED CONTINUOUS PATIENT OBSERVATION PROTOCOLS. SAFETY PROTOCOL ADHERENCE: MULTIPLE PROCEDURAL VIOLATIONS INCLUDING INADEQUATE PATIENT MONITORING AND FAILURE TO MAINTAIN PROPER CALIBRATION SCHEDULES. CONCLUSIONS: THIS SEIZURE INCIDENT RESULTED FROM A CONVERGENCE OF BOTH PATIENT-SPECIFIC RISK FACTORS AND SIGNIFICANT PROCEDURAL/DEVICE-RELATED PROTOCOL VIOLATIONS. THE PATIENT'S MEDICATION REGIMEN (VYVANSE) AND SUBSTANCE USE (MARIJUANA) CREATED AN ELEVATED BASELINE SEIZURE RISK, WHILE MULTIPLE PROCEDURAL DEVIATIONS, INCLUDING FAILURE TO MAINTAIN WEEKLY MOTOR THRESHOLD RECALIBRATION PER MANUFACTURER GUIDELINES AND INADEQUATE PATIENT MONITORING DURING ACTIVE TREATMENT, CREATED UNSAFE TREATMENT CONDITIONS. BOTH THE PATIENT'S UNDERLYING CONDITION AND RISK FACTORS, AS WELL AS DEVICE-RELATED PROCEDURAL FACTORS AND PROTOCOL VIOLATIONS, CONTRIBUTED TO THE OCCURRENCE OF THIS SEIZURE EVENT. THE SERVICE TEAM INVESTIGATION INCLUDED DEVICE INSPECTION, HOWEVER, THE INABILITY TO CONDUCT STAFF INTERVIEWS AND RETRAINING DURING THE SITE VISIT REPRESENTS AN INCOMPLETE REMEDIATION OF THE IDENTIFIED PROCEDURAL ISSUES. IMPLEMENTATION OF STRICT ADHERENCE TO MANUFACTURER PROTOCOLS AND CONTINUOUS PATIENT MONITORING REQUIREMENTS IS ESSENTIAL FOR PREVENTING SIMILAR INCIDENTS, AND COMPLETION OF STAFF RETRAINING REMAINS PENDING.

Description of Event or Problem

PATIENT EXPERIENCED A GENERALIZED TONIC-CLONIC SEIZURE DURING TREATMENT SESSIONS #18. PATIENT'S RIGHT ARM STIFFEN, FOLLOWED BY THE PATIENT SLUMPING TO THE RIGHT SIDE AND EXHIBITING FULL-BODY SHAKING CONSISTENT WITH GENERALIZED CONVULSIVE ACTIVITY. PATIENT REMAINED UNRESPONSIVE FOR APPROXIMATELY ONE MINUTE FOLLOWING CESSATION OF CONVULSIVE MOVEMENTS. POST-ICTAL CONFUSION PERSISTED FOR APPROXIMATELY FIVE TO SIX MINUTES. NO SIGNIFICANT INJURIES WERE SUSTAINED DURING THE EVENT, THOUGH A POSSIBLE MINOR TONGUE BITE WAS NOTED WITHOUT ASSOCIATED BLEEDING. IMPORTANTLY, NO URINARY OR BOWEL INCONTINENCE OCCURRED DURING OR AFTER THE SEIZURE. PATIENT WAS TRANSPORTED TO THE EMERGENCY DEPARTMENT FOR EVALUATION AND WAS SUBSEQUENTLY DISCHARGED HOME THE SAME DAY.