BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS POWER SUPPLY

    MDR report key: 13423393 · Received February 2, 2022

    Report

    Report Number
    3004936110-2022-00052
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    January 28, 2022
    Report Date
    February 24, 2022
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    MOM
    UDI-DI
    05414734509800
    PMA / PMN Number
    P100045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PATIENT ELECTRONICS UNIT (PES) WITH MODEL CM100 WITH S/N (B)(6) AND ACCESSORIES WERE RETURNED FOR EVALUATION. VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE TO THE UNIT. THE PES ALSO PASSED SOFTWARE EVALUATION. DURING FUNCTIONAL TESTING, THE UNIT POWERED ON WITH NO ANOMALIES NOTED AND DID NOT UNEXPECTEDLY SHUT DOWN. THE PEU WAS ABLE TO LOAD TO THE START SCREEN AND PASSED DIAGNOSTIC TESTING. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN AS THE RETURNED PEU PASSED ALL TESTING.

    Description of Event or Problem · 0

    THE PATIENT REPORTED SPARKING COMING FROM THE POWER SUPPLY CORD OF THE PATIENT ELECTRONICS UNIT. THE UNIT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102413 CARDIOMEMS POWER SUPPLY SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. CM1110 05414734509800

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Unknown