BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP TRANSCRANIAL MAGNETIC STIMULATOR

    MDR report key: 24921078 · Received April 19, 2026

    Report

    Report Number
    3010300912-2026-23727
    Event Type
    Injury
    Date Received
    April 19, 2026
    Date of Event
    February 27, 2026
    Report Date
    April 19, 2026
    Manufacturer
    BRAINSWAY LTD.
    Product Code
    OBP
    UDI-DI
    07290110538026
    PMA / PMN Number
    K173540
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER INTERNAL MEDICAL REVIEW, THE SEIZURE IS LIKELY ASSOCIATED WITH A GENETIC PREDISPOSITION FOR SEIZURES AND A HIGH MOTOR THRESHOLD. ACCORDING TO THE DEVICE INSTRUCTIONS FOR USE - THE DEVICE SHOULD NOT HAVE BEEN USED ON A PATIENT WITH A FIRST DEGREE RELATIVE WITH A HISTORY SEIZURES. THE COMPANY'S MEDICAL AFFAIRS TEAM HAD A DISCUSSION WITH THE PROVIDER TO DISCUSS THE EVENT AND PROVIDE FURTHER EDUCATION AND AWARENESS SURROUNDING BEST PRACTICES FOR MOTOR THRESHOLD PROCEDURES AND THE INFLUENCE OF FAMILY HISTORY OF SEIZURES ON A PATIENT'S PROPENSITY FOR THIS TYPE OF EVENT.

    Description of Event or Problem · 0

    39 YEAR OLD PATIENT WITH MDD HAS A SEIZURE DURING TMS TREATMENT SESSION #23. PATIENT WAS UNRESPONSIVE FOR APPROXIMATELY 12 SECONDS, LOST BLADDER CONTROL AND VOMITED. PATIENT WAS POST ICTAL FOR APPROXIMATELY 25 MINUTES. PATIENT WAS EVALUATED IN THE ER AND RELEASED FOLLOWING NO ABNORMAL FINDINGS ON CT. THE ONLY REMARKABLE FINDINGS FROM ER WAS A UTI. THE PATIENT HAS A FATHER AND BROTHER WITH A HISTORY SEIZURES. FURTHERMORE, THE PATIENT'S MOTOR THRESHOLD WAS RELATIVELY HIGH. CONSEQUENTLY, AFTER INTERNAL MEDICAL REVIEW, THE SEIZURE IS LIKELY ASSOCIATED WITH A GENETIC PREDISPOSITION FOR SEIZURES AND A HIGH MOTOR THRESHOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7719 DEEP TRANSCRANIAL MAGNETIC STIMULATOR TRANSCRANIAL MAGNETIC STIMULATOR OBP BRAINSWAY LTD. 104 07290110538026

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female Other PRISTIQUE 50 MG.