BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3924941 · Received June 18, 2014

    Report

    Report Number
    2916596-2014-01012
    Event Type
    Death
    Date Received
    June 18, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 19, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS ADMITTED ON (B)(6) 2014 WITH HEMATURIA X 1.5 DAY AND LDH OF 2457. THE PT REPORTED EXPERIENCING SHORTNESS OF BREATH, WEIGHT GAIN, ACTIVITY INTOLERANCE, AND FLUID OVERLOAD. THE PT WAS STARTED ON HEPARIN GTT. THE PT FAILED MEDICAL MANAGEMENT. HE WAS MADE DNR. SUPPORT WAS WITHDRAWN AND PT EXPIRED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356760 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 113700

    Patients

    Seq Age Sex Outcome Treatment
    1 Death