BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART

    MDR report key: 2243918 · Received September 6, 2011

    Report

    Report Number
    3003761017-2011-00023
    Event Type
    Death
    Date Received
    September 6, 2011
    Date of Event
    August 8, 2011
    Report Date
    September 6, 2011
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    LOZ
    PMA / PMN Number
    P030011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TAH-T WAS EXPLANTED AND VISUALLY INSPECTED AT (B)(6), AND THROMBUS WAS OBSERVED IN THE TAH-T. AN AUTOPSY WAS PERFORMED, AND RESULTS OF THE AUTOPSY ARE PENDING. SYNCARDIA WAS REQUESTED THAT THE TAH-T AND FREEDOM DRIVERS BE RETURNED FOR INVESTIGATION. AT THIS TIME, THERE IS NO EVIDENCE THAT THE PT'S DEATH WAS CAUSED BY A MALFUNCTION OF THE TAH-T OR FREEDOM DRIVERS. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A PT WAS IMPLANTED WITH THE SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) AT (B)(6) IN (B)(6), SUPPORTED BY CSS CONSOLE S/N (B)(4). ON (B)(6) 2011, HE WAS SWITCHED FROM THE CSS CONSOLE TO THE CE-APPROVED PORTABLE FREEDOM DRIVE S/N (B)(4). ON OR ABOUT (B)(6) 2011, HE WAS DISCHARGED TO HOME. CUSTOMER AT (B)(6) REPORTED THAT ON (B)(6) 2011, THE PT'S WIFE REPORTED THAT WHILE THE PT WAS HAVING A BOWEL MOVEMENT, FREEDOM DRIVER (B)(4) EXHIBITED A FAULT ALARM. THE PT REPORTEDLY LOST CONSCIOUSNESS. THE PT'S SON EXCHANGED FREEDOM DRIVER (B)(4) TO THE BACKUP FREEDOM DRIVER (B)(4). THE PT WAS TAKEN TO THE LOCAL CLINIC BY EMERGENCY SERVICES, WHERE HE SUBSEQUENTLY EXPIRED.

    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 072627

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death