BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 2650353 · Received July 3, 2012

    Report

    Report Number
    3003761017-2012-00026
    Event Type
    Injury
    Date Received
    July 3, 2012
    Date of Event
    June 8, 2012
    Report Date
    July 2, 2012
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED TAH-T VENTRICLES WERE RETURNED TO SYNCARDIA FOR EVAL. THE EXPLANTED VENTRICLES WERE FOUND TO BE IN EXCELLENT CONDITION, AND THERE WAS NO EVIDENCE OF MALFUNCTION OF VALVES OR DIAPHRAGMS. THE VALVES WERE FULLY FUNCTIONAL AND FREE OF ANY OBSTRUCTIONS. THERE WAS NO EVIDENCE OF ANY DEFECT OF MATERIALS OR WORKMANSHIP. THERE WAS NO EVIDENCE OF THROMBUS IN THE DEVICE. THERE WAS NO EVIDENCE OF DEVICE MALFUNCTION. THE INVESTIGATION OF THIS ISSUE BY SYNCARDIA IS STILL IN PROCESS. THE FINAL RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    PT (B)(4) WAS IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) ON (B)(6), 2012. ONE MONTH LATER, ON (B)(6) 2012, THE CUSTOMER REPORTED THAT THE PT WAS CLINICALLY DECLINING AND EXPERIENCED INTERMITTENT DECREASED CARDIAC OUTPUT/FILL VOLUME DURING AN EIGHT TO TEN HOUR PERIOD. AFTER DEVICE OPTIMIZATION, ECHOCARDIOGRAM, X-RAY AND CHEST EXPLORATION, THE SURGEON DECIDED TO REPLACE THE TAH-T VENTRICLES. THE TAH-T VENTRICLES FROM LOT 071289 WERE REMOVED AND WERE REPLACED WITH TAH-T VENTRICLES FROM LOT 080136. THE CUSTOMER REPORTED THAT THE PT IS DOING WELL AND IS FOLLOWING AN EXPECTED COURSE OF RECOVERY ON THE TAH-T.

    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 070289

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other