BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 1995937 · Received February 11, 2011

    Report

    Report Number
    3003761017-2011-00007
    Event Type
    Other
    Date Received
    February 11, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 10, 2011
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    FRENCH DISTRIBUTOR REPORTED TO SYNCARDIA THAT PATIENT (B)(6) WAS IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) ON (B)(6) 2010, AT (B)(6) IN (B)(6). ON OR ABOUT (B)(6) 2010, HE WAS DISCHARGED TO HOME WITH THE CE-MARKED SYNCARDIA FREEDOM DRIVER. ON (B)(6) 2011, (B)(6) NOTIFIED SYNCARDIA'S (B)(6) DISTRIBUTOR THAT PATIENT (B)(6) HAD AN AIR LEAK FROM A HOLE IN ONE OF THE VENTRICLE CANNULAE IN THE AREA OF THE WIRE REINFORCEMENT. THE HOLE IN THE CANNULA WAS REPAIRED AT THE HOSPITAL WITH SPECIAL TAPE THAT VULCANIZED THE LEAK AND PLASTIC TUBES AROUND THE AREA FOR STABILIZATION. THE HOSPITAL REPORTED THAT THERE WAS NO ADVERSE IMPACT ON THE PATIENT, THE PATIENT WAS DOING WELL, AND HE WILL BE LISTED ON THE EMERGENCY LIST FOR TRANSPLANT. SYNCARDIA HAS REQUESTED THE HOSPITAL TO RETURN THE TAH-T AND CANNULAE TO SYNCARDIA FOR EVALUATION WHEN THE PATIENT IS TRANSPLANTED. THE RESULTS OF THE EVALUATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART TAH-T LOZ SYNCARDIA SYSTEMS, INC. TAH-T 067095

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR