BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS POWER SUPPLY

    MDR report key: 24871016 · Received April 14, 2026

    Report

    Report Number
    3004936110-2026-00696
    Event Type
    Malfunction
    Date Received
    April 14, 2026
    Date of Event
    February 5, 2026
    Report Date
    April 14, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MOM
    PMA / PMN Number
    P100045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE POWER SUPPLY AND ONE POWER CORD MODEL WERE RETURNED FOR EVALUATION. VISUAL EVALUATION REVEALED DAMAGE TO THE POWER SUPPLY SHOWING FRAYED WIRE. VISUAL EVALUATION REVEALED NO DAMAGE TO THE POWER CORD. POWER SUPPLY DETERMINED TO BE DAMAGED DUE TO EXPOSED WIRES. POWER CORD FUNCTIONS AS INTENDED. IT WAS REPORTED THAT THE PES IS NOT POWERING ON. REPORTED EVENT WAS VISUALLY CONFIRMED. POWER SUPPLY HAS EXPOSED WIRES. POWER CORD FUNCTIONS AS INTENDED.

    Description of Event or Problem · 0

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING EXPOSED WIRES OF THE POWER SUPPLY CABLE. THE PATIENT ELECTRONIC UNIT WAS REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940806 CARDIOMEMS POWER SUPPLY System, hemodynamic, implantable MOM ABBOTT MEDICAL CM1110

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male