BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA CARDIOWEST

    MDR report key: 3058695 · Received April 15, 2013

    Report

    Report Number
    3058695
    Event Type
    Injury
    Date Received
    April 15, 2013
    Date of Event
    January 4, 2008
    Report Date
    April 1, 2013
    Manufacturer
    SYNCARDIA SYSTEMS, INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS INTERMITTENTLY HEMODYNAMICALLY UNSTABLE. A TEE REVEALED THAT THE CENTRAL LINE WAS INTERFERING WITH THE FUNCTION OF THE INFLOW VALVE OF THE TAH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161073 SYNCARDIA CARDIOWEST TOTAL ARTIFICIAL HEART (TAH) DSQ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1