BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS PATIENT ELECTRONIC SYSTEM

    MDR report key: 18865137 · Received March 8, 2024

    Report

    Report Number
    3004936110-2024-00366
    Event Type
    Malfunction
    Date Received
    March 8, 2024
    Date of Event
    February 12, 2024
    Report Date
    March 8, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509800
    PMA / PMN Number
    P100045
    Removal / Correction Number
    FA-Q323-HF-4
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FA-Q323-HF-4 CARDIOMEMS PES RIGHT ANGLE POWER EXTENSION CABLE FAILURE NOTICE ISSUED BY ABBOTT ON 04 OCT 2023. ONE CARDIOMEMS PATIENT ELECTRONIC SYSTEM WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF RETURNED MATERIAL REVEALED FUNCTIONAL DAMAGE TO POWER EXTENSION CABLE IN THE FORM OF THE DC JACK CONNECTOR AND PVC OVERMOLD PORTION PARTIALLY BROKEN OFF FROM THE 16 AWG 2C TS WIRE. EXPOSED FRAYED AND BROKEN INTERNAL WIRES WERE VISIBLE FROM THIS DAMAGED AREA OF THE POWER EXTENSION CABLE. THE BACKPLATE OF THE DEVICE WAS REMOVED AND A STANDARD POWER SUPPLY WAS CONNECTED TO THE UNIT. THE UNIT WAS POWERED ON WITH NO ISSUES OBSERVED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THAT NO NON-CONFORMANCES 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 EXPOSED WIRES OF THE POWER EXTENSION CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909114 CARDIOMEMS PATIENT ELECTRONIC SYSTEM System, hemodynamic, implantable MOM ST. JUDE MEDICAL, INC. CM1100 8427440 05414734509800

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male