BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS POWER SUPPLY

    MDR report key: 21103634 · Received January 8, 2025

    Report

    Report Number
    3004936110-2025-00035
    Event Type
    Malfunction
    Date Received
    January 8, 2025
    Date of Event
    January 7, 2025
    Report Date
    March 11, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MOM
    PMA / PMN Number
    P100045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CARDIOMEMS PATIENT ELECTRONIC SYSTEM WITH POWER ACCESSORIES WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION VERIFIED THE POWER SUPPLY WAS FRAYED AND WIRES WERE EXPOSED. EXPOSED WIRES OF THE POWER SUPPLY WAS REPORTED IN MDR-2025-01209-01. 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN A SUBSEQUENT SUBMISSION.

    Description of Event or Problem · 0

    THE PATIENT REPORTED EXPOSED WIRES AND SPARKING OF THE POWER SUPPLY. THE PATIENT ELECTRONIC UNIT WITH POWER ACCESSORIES WAS REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104312 CARDIOMEMS POWER SUPPLY SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ABBOTT MEDICAL CM1110

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male