BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4477005 · Received February 2, 2015

    Report

    Report Number
    4477005
    Event Type
    Death
    Date Received
    February 2, 2015
    Date of Event
    June 3, 2014
    Report Date
    July 11, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6)

    Description of Event or Problem · 1

    PT. ADMITTED FROM CLINIC DUE TO FATIGUE/WEAKNESS. PATIENT WAS THOUGHT TO HAVE A POSSIBLE PUMP THROMBUS AFTER RHC. PATIENT LISTED STATUS 1A FOR OHT. PT HAD AROTIC VALVE CLOSURE PROCEDURE. PT. EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75743 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death