BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSM ANTENNA

    MDR report key: 22621181 · Received July 25, 2025

    Report

    Report Number
    3004936110-2025-01467
    Event Type
    Malfunction
    Date Received
    July 25, 2025
    Report Date
    July 25, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MOM
    PMA / PMN Number
    P100045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CARDIOMEMS I2 PATIENT ELECTRONICS SYSTEM WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION OF RETURNED MATERIAL REVEALED FUNCTIONAL DAMAGE TO THE SMA QUAD BAND 6IN RUBBER DUCK ANTENNA, WHICH IS COMMONLY REFERRED TO AS THE GSM ANTENNA. DAMAGE TO THE GSM ANTENNA CAME IN THE FORM OF THE SMA CONNECTOR PORTION BROKEN OFF FROM THE REST OF THE COMPONENT RESULTING IN EXPOSED ANTENNA CONTACTS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THAT NO MANUFACTURING NON-CONFORMANCE'S WERE IDENTIFIED THAT ARE RELATED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING A BROKEN GSM ADAPTOR RESULTING IN EXPOSED ANTENNA CONTACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2639308 GSM ANTENNA System, hemodynamic, implantable MOM ABBOTT MEDICAL CM1040

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown