BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCARDIA CARDIOWEST

    MDR report key: 3013683 · Received March 20, 2013

    Report

    Report Number
    3013683
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    January 31, 2013
    Report Date
    March 18, 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

    BOTH FREEDOM DRIVERS ALARMED. PATIENT ASYMPTOMATIC. PROVIDED NEW DRIVERS AND DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115275 SYNCARDIA CARDIOWEST TOTAL ARTIFICIAL HEART (TAH) DSQ SYNCARDIA SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1