BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2863084 · Received December 10, 2012

    Report

    Report Number
    2863084
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    September 17, 2012
    Report Date
    December 6, 2012
    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 ADMITTED AND NOTED TO HAVE HIGH POWERS. ON (B)(6) 2012, HIS PUMP STOPPED WORKING AND THE PT WENT INTO CARDIOGENIC SHOCK-TAKEN TO OPERATING ROOM FOR EXCHANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1