BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4907546 · Received July 10, 2015

    Report

    Report Number
    4907546
    Event Type
    Death
    Date Received
    July 10, 2015
    Date of Event
    June 5, 2015
    Report Date
    June 15, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    PATIENT ADMITTED FOR FALL, UPON ADMISSION FOUND TO HAVE ELEVATED LDH. POSITIVE RAMP STUDY ON (B)(6) 2015. LDH CONTINUED TO RISE OVER THE WEEKEND. PATIENT WAS TRANSFERRED TO CVICU WITH ELEVATED LDH, ELEVATED CR AND RESPIRATORY DISTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451244 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death