BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 2413537 · Received January 6, 2012

    Report

    Report Number
    3003761017-2012-00001
    Event Type
    Injury
    Date Received
    January 6, 2012
    Date of Event
    December 12, 2011
    Report Date
    January 6, 2012
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) AT THE (B)(6), ON (B)(6) 2010. ON (B)(6) 2011, THE CUSTOMER AT (B)(6) REPORTED THAT AFTER 435 IMPLANT DAYS, AN AIR LEAK HAD DEVELOPED IN THE PT'S RIGHT TAH-T CANNULA IN THE MIDDLE OF THE WIRE REINFORCEMENT. THE COORDINATORS AT THE HOSPITAL REPAIRED THE AIR LEAK BY WRAPPING THE CANNULA WITH SELF-VULCANIZING TAPE AND STABILIZING IT WITH TUBE ISOLATION. THE CUSTOMER REPORTED THAT THERE WAS NO ADVERSE IMPACT ON THE PT. THE PT IS CURRENTLY LISTED ON THE HEART TRANSPLANT LIST. SYNCARDIA HAS REQUESTED THAT THE TAH-T AND CANNULAE BE RETURNED FOR EVAL AFTER THE PT IS TRANSPLANTED. THE RESULTS OF THE INVESTIGATION 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 068131

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention