BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3202924 · Received July 2, 2013

    Report

    Report Number
    3202924
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    April 13, 2013
    Report Date
    July 2, 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

    PT SHOWED SIGNS OF END-ORGAN FAILURE(LIVER AND KIDNEY), ALSO, VAD HAD BEEN SHOWING POWER RISE. THE SURGEON ALSO NOTED THAT HE HAD A LONGER OUTFLOW GRAFT WHICH LOOKED LIKE KINKING JUST ABOVE THE RIGHT ATRIAL APPENDAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300835 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1