BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA CARDIOWEST

    MDR report key: 3007433 · Received March 15, 2013

    Report

    Report Number
    3007433
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    August 2, 2007
    Report Date
    March 14, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AN ECHO REVEALED A THOMBI IN THE RIGHT ATRIAL PORTION OF THE TAH-T, NEAR THE AV VALVE OF THE LEFT ATRIUM AND IN THE THORACIC AORTA. NO FLOW WAS OBSTRUCTED AND THE THROMBI DID NOT CONTRIBUTE TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109581 SYNCARDIA CARDIOWEST TOTAL ARTIFICIAL HEART (TAH) DSQ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1