BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4682195 · Received April 10, 2015

    Report

    Report Number
    4682195
    Event Type
    Death
    Date Received
    April 10, 2015
    Date of Event
    February 12, 2015
    Report Date
    March 31, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    READMITTED IN (B)(6) WITH HIGH LDH, HEMOLYSIS AND VOLUME OVERLOAD. VAD INTERROGATION REVEALED HIGH FLOWS. HAD A RAMP STUDY THAT CAME BACK POSITIVE. DECISION WAS MADE TO UPGRADE PATIENT TO UNOS STATUS 1AB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238462 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death