BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS POWER SUPPLY

    MDR report key: 24363698 · Received February 17, 2026

    Report

    Report Number
    3004936110-2026-00301
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    February 10, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MOM
    PMA / PMN Number
    P100045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ONE POWER SUPPLY AND ONE POWER CORD WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION VERIFIED THE POWER SUPPLY WAS FRAYED AND WIRES WERE EXPOSED. NO VISIBLE DAMAGE WAS OBSERVED ON ANY OTHER RETURNED CABLES AND CORDS ASSOCIATED WITH POWER CONNECTIONS. 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.

    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 FRAY AND SPARKING OF THE POWER SUPPLY. 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
    60774 CARDIOMEMS POWER SUPPLY SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ABBOTT MEDICAL CM1110

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female