BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3141063 · Received June 3, 2013

    Report

    Report Number
    3141063
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 20, 2013
    Report Date
    May 24, 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

    PATIENT HAD TO HAVE THREE CONTROLLERS REPLACED WITHIN A FOUR MONTH TIME SPAN. BROUGHT PATIENT IN TO INVESTIGATE AND PERFORMED CONTINUITY TEST WHICH REVEALED A FRACTURED WIRE WITHIN DRIVELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245198 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1