BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSM ANTENNA

    MDR report key: 21285651 · Received January 31, 2025

    Report

    Report Number
    3004936110-2025-00181
    Event Type
    Malfunction
    Date Received
    January 31, 2025
    Date of Event
    October 16, 2024
    Report Date
    January 31, 2025
    Manufacturer
    ABBOTT MEDICAL.
    Product Code
    MOM
    PMA / PMN Number
    P100045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION OF RETURNED MATERIAL REVEALED FUNCTIONAL DAMAGE TO THE GSM ANTENNA. DAMAGE TO THE GSM ANTENNA CAME IN THE FORM OF THE RADOME PORTION SPLIT OPEN WITH THE POTENTIAL FOR EXPOSED WIRING.

    Description of Event or Problem · 0

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A BREAK IN THE GSM ADAPTOR RESULTING IN THE POTENTIAL FOR EXPOSED WIRES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494401 GSM ANTENNA System, hemodynamic, implantable MOM ABBOTT MEDICAL. CM1040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown