BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 2472087 · Received February 22, 2012

    Report

    Report Number
    3003761017-2012-00007
    Event Type
    Injury
    Date Received
    February 22, 2012
    Date of Event
    January 27, 2012
    Report Date
    February 20, 2012
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) ON (B)(6), 2010. SHE WAS TRANSFERRED FROM THE CIRCULATORY SUPPORT SYSTEM (CSS) CONSOLE TO THE INVESTIGATIONAL FREEDOM DRIVER SYSTEM ON (B)(6), 2011. ON (B)(6), 2012, AFTER 418 DAYS ON DEVICE, THE HOSPITAL VAD COORDINATOR REPORTED THAT A TEAR HAD DEVELOPED IN THE CANNULA OF THE PT'S RIGHT TAH-T VENTRICLE. THE PT WENT TO THE HOSPITAL AND THE CANNULA TEAR WAS REPAIRED AT THE HOSPITAL. SHE WAS DISCHARGED TO HOME THE SAME DAY. THERE WAS NO IMPACT ON THE PT. SYNCARDIA HAS REQUESTED THAT THE TAH-T AND CANNULAE BE RETURNED TO SYNCARDIA FOR EVAL AFTER THE PT HAS BEEN TRANSPLANTED. THE RESULTS OF THE EVAL WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART ARTIFICIAL HEART LOZ SYNCARDIA SYSTEMS, INC. TAH-T 070328

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention