BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2930322 · Received January 24, 2013

    Report

    Report Number
    2916596-2013-00091
    Event Type
    Death
    Date Received
    January 24, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS 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 WENT INTO A LOCAL HOSPITAL EMERGENCY ROOM. THE PT WAS IN CARDIOGENIC SHOCK AND WAS INTUBATED. THE PT DID NOT WAKE UP FROM SEDATION AFTER STABILIZING HIS CARDIOGENIC SHOCK. A CAT SCAN (CT) WAS PERFORMED AND A MAJOR HEAD BLEED WAS FOUND. IT WAS NOTED THAT THE PT HAD BEEN NON COMPLIANT. THE PT WAS PLACED ON DOBUTAMINE, PRIMACOR, LEVOPHED AND INTUBATED. DUE TO THE HEAD BLEED, THE PUMP WAS STOPPED AND PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34167 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 100443

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death