BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4492279 · Received February 6, 2015

    Report

    Report Number
    4492279
    Event Type
    Death
    Date Received
    February 6, 2015
    Date of Event
    May 11, 2014
    Report Date
    June 5, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6)

    Description of Event or Problem · 1

    PATIENT HAS A HISTORY OF THROMBUS, CONSISTENTLY LOW FLOWS AT THIS ADMISSION ON HM II AND RISING LD. PATIENT WAS NOT A CANDIDATE FOR REPEAT VAD EXCHANGE, TRANSPLANT OR OTHER ADVANCED THERAPIES. PATIENT RENTAL FUNCTION HAD WORSENED, HIS LACTATE WAS HIGH, ACIDOTIC AND MINIMALLY RESPONDING DUE SUBARACHNOID HEMORRHAGE. FAMILY DECIDED TO MAKE THE PATIENT DNR/DNI AND COMFORT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89132 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death