BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST. JUDE/THORATEC HEARTMATE II LVAD

    MDR report key: 6098565 · Received November 9, 2016

    Report

    Report Number
    MW5065960
    Event Type
    Death
    Date Received
    November 9, 2016
    Date of Event
    November 2, 2016
    Report Date
    November 9, 2016
    Manufacturer
    ST. JUDE/THORATEC
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE (B)(6) FOR DESTINATION THERAPY. LVAD REPLACED IN (B)(6) RELATED TO AORTIC INSUFFICIENCY. SHE HAD BEEN WELL. SHE WENT TO BATHROOM AT 4 AM. ON WALK BACK TO BED COLLAPSED. HUSBAND STATED NOT BREATHING, UNAROUSABLE, 911 CALLED. PRONOUNCED DEAD AT EMERGENCY ROOM. ON ARRIVAL TO EMERGENCY ROOM ON EXAM PUPILS FIXED AND DILATED. NO END TIDAL CO2 DETECTED, VAD HUM PRESENT. PATIENT PRONOUNCED EXPIRED AND VAD TURNED OFF WITH FAMILY PRESENT. PTS HUSBAND CALLED TO REPORT YELLOW WRENCH ALARM ON PBU. PT WAS INSTRUCTED TO REMOVE THE BATTERY FROM THE PBU. HE DOES HAVE A BACK UP BATTERY. HUSBAND WILL CALL WHEN HE IS ABLE TO SUCCESSFULLY REPLACE THE BATTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742471 ST. JUDE/THORATEC HEARTMATE II LVAD HEARTMATE II LVAD DSQ ST. JUDE/THORATEC 29257 83150

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death ACIDOPHILLIS| ACYLOVIR (ZOVIRAX) 800 MG TABLET.| ASA| CARVEDILOL| COLACE| COUMADIN| DOXYCYCLINE| LOSARTAN| NEURONTIN| OXYCODONE| PRILOSEC