BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMBLEM S-ICD

    MDR report key: 19532905 · Received June 13, 2024

    Report

    Report Number
    2124215-2024-36280
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 31, 2024
    Report Date
    June 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526599200
    PMA / PMN Number
    P110042/S077
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEALTH CARE PROFESSIONAL (HCP) CALLED FOR REVIEW OF DEVICE DATA FOR THIS PATIENT WITH A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM. IT WAS ALSO NOTED THAT THE PATIENT HAS A CONCOMITANT MICRA DEVICE. TECHNICAL SERVICES REVIEWED THE DATA AND FOUND THE PATIENT HAD ONE INAPPROPRIATE SHOCK DUE TO OVERSENSING OF T WAVES, AND LOW AMPLITUDES. THE DEVICE IS PROGRAMMED TO SECONDARY VECTOR WITH 1X GAIN. TECHNICAL SERVICES PROVIDED TROUBLESHOOTING OPTIONS. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    938207 EMBLEM S-ICD IMPLANTABLE ELECTRODE LWS BOSTON SCIENTIFIC CORPORATION 3501 245715 00802526599200

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female