BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3945095 · Received July 18, 2014

    Report

    Report Number
    3945095
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    April 2, 2014
    Report Date
    July 15, 2014
    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

    INTERROGATED VAD-MULTI PUMP STOPS; WAVEFORMS SENT & ENGINEER THORATEC NOTIFIED;C-ARM VIEWED DL; YELLOW WIRE COMPROMISED-BREAK INTERNAL;ATTEMPTED TO CHANGE DL PUMP WON'T RESTART; BACK ON OLD DL; PERC LEAD REPAIR DONE; PUMP RESTARTED, BUT CONTINUES TO STOP. PRIMARY COD: DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421284 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death