BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3121607 · Received May 16, 2013

    Report

    Report Number
    2916596-2013-00590
    Event Type
    Death
    Date Received
    May 16, 2013
    Date of Event
    March 20, 2013
    Report Date
    April 17, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WILL NOT BE RETURNED TO THE MFR FOR EVAL. NO FURTHER INFORMATION 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). APPROX 2 DAYS POST IMPLANT, THE VAD COORDINATOR REPORTED THAT VAD SUPPORT WAS WITHDRAWN FOR THIS PT DUE TO MULTIPLE ORGAN DYSFUNCTION SYNDROME (MODS). THE PT WAS IN POOR CONDITION PRIOR TO IMPLANT AND REQUIRED TEMPORARY VAD SUPPORT, EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT AND THEN AN RVAD WITH THEIR LVAD IMPLANT. NO AUTOPSY WAS PERFORMED AND THE PUMP WILL NOT BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216611 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 123820

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Death