BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2923407 · Received January 22, 2013

    Report

    Report Number
    2923407
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 20, 2012
    Report Date
    January 18, 2013
    Manufacturer
    THORATEC CORPORATION
    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

    EXTERNAL FRACTURE OF WIRES. QUESTIONABLE INTERNAL WIRE FRACTURE VS. STRESS ON WIRES. DIAGNOSED BY CXR. THORATEC ENGINEERS CAME ON SITE AND COULD NOT REPAIR EXTERNAL WIRES D/T PROXIMITY FROM DL EXIT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30777 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1