BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HORIZON

    MDR report key: 9705314 · Received February 13, 2020

    Report

    Report Number
    3011755356-2020-00001
    Event Type
    Injury
    Date Received
    February 13, 2020
    Report Date
    May 4, 2020
    Manufacturer
    THE MAGSTIM COMPANY LIMITED
    Product Code
    OBP
    PMA / PMN Number
    K183376
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INTO THIS MATTER HAS BEEN MANAGED BY THE PRINCIPLE INVESTIGATOR AT (B)(6) SITE FOR THE BRIGHTMIND STUDY. IN CONFIRMATION TO MAGSTIM, THE PRINCIPLE INVESTIGATOR CONFIRMED THAT THE PATIENT WAS ASSESSED BY THE CONSULTANT NEUROLOGIST AND HAS HAD BOTH EEG AND MRI IN THE WEEKS FOLLOWING THE SUSPECTED SEIZURE. THE RESULTS OF THE EEG AND MRI WHERE REVIEWED BY THE CONSULTANT NEUROLOGIST WITH NEITHER SHOWING ANY CLASSICAL SIGNS OF SEIZURE ACTIVITY. THE CLINICAL DECISION OF THE NEUROLOGIST WAS THAT THE SYMPTOMS PRESENTED BY THE PATIENT DURING THE TRIAL WAS UNLIKELY TO BE A SEIZURE, AND AS SUCH BY AGREEMENT OF THE BRIGHTMIND CHIEF INVESTIGATOR, THE CLASSIFICATION WITHIN THE TRIAL DOWNGRADED FROM SERIOUS ADVERSE EVENT TO ADVERSE EVENT. THE PRINCIPLE INVESTIGATOR ALSO CONFIRMED THAT THE SUSPECTED SEIZURE DID NOT OCCUR DURING THE TMS STIMULATION SESSION, BUT IN THE DAYS FOLLOWING STIMULATION, AND THEREFORE, THE SYMPTOMS PRESENTED NOT LIKELY ATTRIBUTED TO THE TMS STIMULATION. AS SUCH, SUBSEQUENT REVIEW OF THE INVESTIGATION DATA AVAILABLE SUGGESTS THAT HORIZON HAS NOT ATTRIBUTED TO, NOR CAUSED SERIOUS INJURY TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    AN ADVERSE EVENT APPEARS TO HAVE OCCURRED BUT THERE IS NOT YET ENOUGH INFORMATION AVAILABLE TO CLASSIFY THE DEVICE PROBLEM, AND ALSO THEREFORE DEVICE INVESTIGATION HAS NOT TAKEN PLACE (YET). THE MAGSTIM COMPANY LTD. IS, AS PER YOUR REQUEST, CURRENTLY IN THE PROCESS OF SETTING UP A WEBTRADER ACCOUNT FOR MAGSTIM INC. USA. DURING THIS TRANSITION TIME, PLEASE ACCEPT THIS SUBMISSION AS OF THE MAGSTIM COMPANY LTD. AND MAGSTIM INC. USA BOTH. EXEMPTION NUMBER E2018009. (B)(4).

    Description of Event or Problem · 1

    SEIZURE DURING PARTICIPATING IN CLINICAL STUDY BRIGHTMIND. SPONSOR OF STUDY: (B)(6). CHIEF INVESTIGATOR: PROFESSOR (B)(6). FUNDER: (B)(6). BRIGTMIND STANDS FOR BRAIN IMAGE GUIDED TRANSCRANIAL MAGNETIC IN DEPRESSION. BRIGTMIND IS A RANDOMIZED DOUBLE-BLIND CONTROLLED TRIAL OF CONNECTIVITY GUIDED THETA BURST TRANSCRANIAL MAGNETIC STIMULATION VERSUS REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION FOR TREATMENT RESISTANT MODERATE TO SEVERE DEPRESSION: EVALUATION OF EFFICACY, COST EFFECTIVENESS AND MECHANISM OF ACTION. MORE INFORMATION ON THE STUDY CAN BE PROVIDED TO YOU UPON REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169893 HORIZON HORIZON OBP THE MAGSTIM COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other