BEUDAMED
    FDA Adverse Event Death Summary report: N

    HORIZON TMS THERAPY SYSTEM

    MDR report key: 14734386 · Received June 17, 2022

    Report

    Report Number
    3011755356-2022-00002
    Event Type
    Death
    Date Received
    June 17, 2022
    Date of Event
    June 3, 2022
    Report Date
    July 1, 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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FROM THE REVIEW OF THE HORIZON DEVICE MANUFACTURE CONTROL SHEETS, THERE WERE NO DEVIATIONS THROUGHOUT DEVICE PRODUCTION OR PROCEDURES. THE DEVICE PASSED ALL MANUFACTURE INSPECTION AND RELEASE CHECKS - AS SUCH THERE WERE NO PROBLEMS WITH THE DEVICE IDENTIFIED. THERE HAVE BEEN NO PREVIOUS REPORTS OF ANY UNEXPECTED OR SIMILAR INCIDENTS WITH THE DEVICE. INVESTIGATION IDENTIFIED THAT THE PATIENT SUFFERED FROM MDD, COMORBID WITH PTSD AND BORDERLINE PD. THESE CONDITIONS ARE KNOWN TO PLACE A PATIENT AT AN INCREASED RISK OF SUICIDE. AS THERE WERE NO ISSUES NOTED WITHIN THE DEVICE'S MANUFACTURE OR USE, AND CONSIDERING THE PATIENT'S DIAGNOSIS, IT MAY BE ACCEPTED THAT THE INCIDENT IS NOT ATTRIBUTABLE TO THE DEVICE.

    Description of Event or Problem · 0

    MAGSTIM LTD WAS INFORMED BY A USER AT THE (B)(6) VAMC THAT A PATIENT WHO HAD BEEN RECEIVING TREATMENT FROM THEM HAD TAKEN THEIR OWN LIFE. THE PATIENT IS KNOWN TO SUFFER WITH MAJOR DEPRESSIVE DISORDER, COMORBID PTSD AND BORDERLINE PERSONALITY DISORDER. THE PATIENT WAS TOWARDS THE END OF THEIR THETA BURST TREATMENT COURSE OF TMS USING MAGSTIM DEVICES, AS SUCH MAGSTIM ARE SUBMITTING THIS INITIAL REPORT AS A CAUTIONARY RESPONSE TO ENSURE VIGILANCE TIMELINES ARE ADHERED TO WHILST ALLOWING TIME FOR A FULL INVESTIGATION TO IDENTIFY THE ROOT CAUSE.

    Description of Event or Problem · 0

    MAGSTIM LTD WAS INFORMED BY A USER AT THE (B)(6) THAT A PATIENT WHO HAD BEEN RECEIVING TREATMENT FROM THEM HAD TAKEN THEIR OWN LIFE. THE PATIENT IS KNOWN TO SUFFER WITH MAJOR DEPRESSIVE DISORDER, COMORBID PTSD AND BORDERLINE PERSONALITY DISORDER. THE PATIENT WAS TOWARDS THE END OF THEIR THETA BURST TREATMENT COURSE OF TMS USING MAGSTIM DEVICES, AS SUCH MAGSTIM ARE SUBMITTING THIS INITIAL REPORT AS A CAUTIONARY RESPONSE TO ENSURE VIGILANCE TIMELINES ARE ADHERED TO WHILST ALLOWING TIME FOR A FULL INVESTIGATION TO IDENTIFY THE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193938 HORIZON TMS THERAPY SYSTEM HORIZON TMS THERAPY SYSTEM OBP THE MAGSTIM COMPANY LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death