BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS POWER SUPPLY

    MDR report key: 18675399 · Received February 9, 2024

    Report

    Report Number
    3004936110-2024-00229
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    February 7, 2024
    Report Date
    May 10, 2024
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    PMA / PMN Number
    P100045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    ONE CARDIOMEMS PATIENT ELECTRONIC SYSTEM POWER SUPPLY WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION VERIFIED THE POWER SUPPLY'S WIRES WERE EXPOSED. SOFTWARE EVALUATION WAS NOT POSSIBLE WITH MATERIAL RETURNED. A GOLDEN I3 UNIT WAS NOT POWERED ON DURING THIS INVESTIGATION DUE TO THE RETURNED POWER SUPPLY BOX BEING PHYSICAL UNFUNCTIONAL VIA THE RETURNED POWER CORD (CC-002367). COMPLAINT OF ¿DAMAGE POWER BOX¿ CONFIRMED WHEN REGARDING THE RETURNED POWER SUPPLY (CC-002403).

    Description of Event or Problem · 0

    THE PATIENT REPORTED EXPOSED AND FRAYED WIRES OF THE POWER SUPPLY. THE PATIENT ELECTRONIC UNIT'S POWER SUPPLY WAS REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284622 CARDIOMEMS POWER SUPPLY SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM1110

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown