BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 2666782 · Received January 14, 2006

    Report

    Report Number
    3003761017-2006-00003
    Event Type
    Death
    Date Received
    January 14, 2006
    Date of Event
    January 1, 2006
    Report Date
    January 13, 2006
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE WAS IMPLANTED WITH THE SYNCARDIA CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) AND DISCHARGED HOME, APPROXIMATELY 300 MILES AWAY FROM THE TRANSPLANT CENTER, BY THE ATTENDING PHYSICIAN WITH A (B)(6) HEART EXCOR MOBILE DRIVER. AFTER APPROXIMATELY 324 DAYS, THE PT REPORTEDLY EXPERIENCED SHORTNESS OF BREATH AND WAS ADMITTED TO A LOCAL HOSPITAL. BASED UPON THE OBSERVED CONDITIONS, THE LOCAL HOSPITAL TRANSPORTED THE PT VIA HELICOPTER TO THE TRANSPLANT CENTER, (B)(6), WHERE HE LATER EXPIRED. THE FACILITY NOTIFIED SYNCARDIA THAT THEY SUSPECTED A DEVICE FAILURE MAY HAVE CONTRIBUTED TO THE PT'S DEATH. SYNCARDIA HAS REQUESTED THAT THE DEVICE BE RETURNED, AND UPON RECEIPT, AN INVESTIGATION WILL BE PERFORMED.

    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 58804

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death