BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGSTIM STIMULATOR

    MDR report key: 12482108 · Received September 15, 2021

    Report

    Report Number
    MW5104027
    Event Type
    Injury
    Date Received
    September 15, 2021
    Date of Event
    June 1, 2019
    Report Date
    September 14, 2021
    Manufacturer
    MAGSTIM, INC. / THE MAGSTIM COMPANY LTD.
    Product Code
    OBP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT EXPERIENCED INTRACRANIAL HEMORRHAGE APPROXIMATELY 3 WEEKS AFTER RECEIVING A VOLUNTARY DEMONSTRATION WITH THE MEDICAL DEVICE. PATIENT RECEIVED A SINGLE PULSE TMS DEMONSTRATION THAT WAS CONDUCTED BY A TRAINED AND CERTIFIED TMS PROFESSIONAL. THE EVENT WAS NOT RELATED TO STUDY ACTIVITIES AND THEREFORE, THE IRB OF RECORD DETERMINED THE EVENT DID NOT MEET THE DEFINITION OF A UPIRTSO. AS A NSR STUDY, THE EVENT IS BEING REPORTED ACCORDING TO 21 CFR 803. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375591 MAGSTIM STIMULATOR TRANSCRANIAL MAGNETIC STIMULATOR OBP MAGSTIM, INC. / THE MAGSTIM COMPANY LTD. 651501C290655
    1375592 MAGSTIM STIMULATOR TRANSCRANIAL MAGNETIC STIMULATOR OBP MAGSTIM, INC. / THE MAGSTIM COMPANY LTD. 651501C290655

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L