BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HORIZON PERFORMANCE WITH STIMGUIDE

    MDR report key: 15190613 · Received August 9, 2022

    Report

    Report Number
    3011755356-2022-00003
    Event Type
    Injury
    Date Received
    August 9, 2022
    Date of Event
    July 29, 2022
    Report Date
    August 5, 2022
    Manufacturer
    THE MAGSTIM COMPANY LTD.
    Product Code
    OBP
    PMA / PMN Number
    K182853
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    A TECHNICIAN PLACED A COIL ON THE "MDD" LOCATION SAVED IN THE STIMGUIDE. THE PATIENT WAS MAPPED THE PREVIOUS FRIDAY ((B)(6) 2022) BUT NO TRAINS WERE DELIVERED, THEN TREATMENT BEGAN ON THE MONDAY WITH RESTING MT 64% AND THE TARGET MT IS 83%, THEN PROCEEDED WITH 55% ON MONDAY, 79% POWER ON THURSDAY AND 79% POWER ON FRIDAY. ON THE DAY OF THE INCIDENT ((B)(6) 2022) THE PATIENTS TREATMENT WAS STARTED AT 79% POWER. HAND TWITCHING WAS OBSERVED AS IT HAS BEEN FOR EVERY DAY OF THIS PATIENT'S TREATMENT. THE PATIENT HAD A SEIZURE, FELL OUT OF THE CHAIR, AND HIT HIS HEAD ON FLOOR. 911 WAS CALLED. PATIENT WAS COHERENT, AND KNEW HIS NAME AND BIRTHDAY. PARAMEDICS TOOK THE PATIENT TO JFK HOSPITAL FOR ASSESSMENT. INITIAL INVESTIGATION BY MAGSTIM IDENTIFIED THE CLINIC AS BEING A NEW CUSTOMER WITH THIS BEING THE 5TH PATIENT TO RECEIVE TREATMENT. THE PATIENT WAS TAKING SUBOXONE WHICH CAN LOWER THE SEIZURE THRESHOLD (HTTPS://WWW.MEDICINES.ORG.UK/EMC/PRODUCT/4019/SMPC). HOWEVER MOP036-US-06 SECTION 2.1 STATES "FAILURE TO HEED THE FOLLOWING RESTRICTIONS COULD RESULT IN SERIOUS INJURY OR DEATH. TREATMENT IS CONTRAINDICATED IN THE FOLLOWING CASES: TRICYCLIC ANTIDEPRESSANTS, NEUROLEPTIC AGENTS OR ANY OTHER DRUG THAT COULD LOWER SEIZURE THRESHOLD." THE PATIENT ALSO HAD A HISTORY OF OPIATE ABUSE BUT HAD BEEN SOBER SINCE (B)(6) 2022, WHILE MOP036-US-06 SECTION 2.4 PRECAUTIONS STATES A LIST OF SPECIAL PATIENT POPULATIONS IN WHICH THE SAFETY AND EFFECTIVENESS OF TMS THERAPY HAS NOT BEEN ESTABLISHED IN THE FOLLOWING PATIENT POPULATIONS OR CLINICAL CONDITIONS THROUGH A CONTROLLED CLINICAL TRIAL, ONE OF THESE IS PATIENTS WITH HISTORY OF SUBSTANCE ABUSE. IT WAS IDENTIFIED THAT THE PATIENT HAD BEEN EXPERIENCING HAND TWITCHING THROUGHOUT THE PREVIOUS TREATMENTS, IN ACCORDANCE WITH MOP036-US-06 SECTION 4.4.3, HAND TWITCHING THROUGHOUT THE DURATION OF THE TREATMENT, THE USER IS INSTRUCTED TO CEASE AND REASSESS THE TREATMENT AREA/MAPPING. AT THIS STAGE IN THE INVESTIGATION IT IS NOT POSSIBLE TO CONFIRM WHETHER THIS ADVICE WAS FOLLOWED BY THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287601 HORIZON PERFORMANCE WITH STIMGUIDE HORIZON PERFORMANCE WITH STIMGUIDE OBP THE MAGSTIM COMPANY LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Hospitalization