BEUDAMED
    FDA Adverse Event Other Summary report: N

    CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 2667149 · Received January 11, 2006

    Report

    Report Number
    3003761017-2006-00002
    Event Type
    Other
    Date Received
    January 11, 2006
    Date of Event
    December 16, 2005
    Report Date
    January 11, 2006
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT IN (B)(6) HAD A SUCCESSFUL HEART TRANSPLANT AFTER BEING IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) FOR A DURATION OF APPROXIMATELY (B)(6). UPON EXPLANT OF THE TAH-T, THE RIGHT VENTRICLE WAS OBSERVED TO HAVE A BLOOD CLOT BETWEEN THE BLOOD DIAPHRAGM AND THE FIRST INTERMEDIATE DIAPHRAGM. THE DEVICE HAS BEEN RETURNED TO SYNCARDIA AND AN INVESTIGATION WILL BE CONDUCTED. THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART ARTIFICIAL HEART LOZ SYNCARDIA SYSTEMS, INC. TAH-T 58145

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other