BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 3109109 · Received May 6, 2013

    Report

    Report Number
    3003761017-2013-00054
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 1, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DECISION WAS MADE TO REPLACE THE PATIENT'S TAH-T. AFTER BEING SUPPORTED BY TAH-T LOT 071778 FOR 839 DAYS, THE PATIENT'S TAH-T WAS REPLACED WITH TAH-T LOT 073904 ON (B)(6) 2013 WITHOUT INCIDENT. THE CUSTOMER REPORTED THAT AS OF (B)(6) 2013, THE PATIENT IS DOING WELL AND IS ABLE TO WALK AND SIT IN A CHAIR. ALTHOUGH HER LDH LEVELS ARE STILL HIGH, HER URINE IS CLEAR. AT THIS TIME, THERE IS NO INDICATION OF A MALFUNCTION OF THE EXPLANTED TAH-T, THE CSS CONSOLE OR THE FREEDOM DRIVER. THE EXPLANTED TAH-T WILL BE RETURNED TO SYNCARDIA FOR EVALUATION. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) ON (B)(6) 2010 AND IS CURRENTLY ENROLLED IN THE FREEDOM DRIVER SYSTEM IDE STUDY. THE CUSTOMER REPORTED THAT THE PATIENT STATED THAT SHE WAS NOT FEELING WELL. THE CUSTOMER ALSO REPORTED THAT THE FILL VOLUMES DISPLAYED ON THE FREEDOM DRIVER WERE IN THE 30S AND CARDIAC OUTPUT WAS IN THE UPPER 4 LITERS PER MINUTE RANGE. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL. ON (B)(6) 2013, SHE WAS SWITCHED FROM THE FREEDOM DRIVER TO A CSS CONSOLE AND HER CARDIAC OUTPUT IMPROVED, AND THE PATIENT STATED THAT SHE FELT BETTER. THE CUSTOMER ALSO REPORTED THAT DURING THE TIME WHEN THE PATIENT WAS BEING SUPPORTED BY THE CSS CONSOLE, SHE SHOWED SIGNS OF HEMOLYSIS AND BLOODY URINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196038 SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART ARTIFICIAL HEART LOZ SYNCARDIA SYSTEMS, INC. TAH-T 071778

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR