BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE INC. LVAD

    MDR report key: 5675353 · Received May 19, 2016

    Report

    Report Number
    MW5062452
    Event Type
    Death
    Date Received
    May 19, 2016
    Date of Event
    May 15, 2016
    Report Date
    May 18, 2016
    Manufacturer
    HEARTWARE INC
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT DIED WHILE ON LEFT VENTRICULAR ASSIST DEVICE (HEARTWARE LVAD) SUPPORT OF AN INTRACRANIAL HEMORRHAGE. PT UNDERWENT HEARTWARE LVAD PLACEMENT FOR STAGE D, CLASS IV ISCHEMIC CARDIOMYOPATHY ON (B)(6) 2016. HE HAD A COMPLICATED POST OPERATIVE COURSE THAT REQUIRED CESSATION OF HIS ANTICOAGULATION. ON (B)(6) 2016 HE BECAME UNRESPONSIVE. NEUROLOGY WAS CONSULTED AND HEAD CT DEMONSTRATED LARGE INTRAPARENCHYMAL HEMATOMAS ASSOCIATED WITH RIGHTWARD SHIFT AND HERNIATION, BRAINSTEM COMPRESSION. NEUROLOGY TESTED HIM AND FOUND HIM TO BE BRAIN DEAD. HE WAS TAKEN OFF LIFE SUPPORT AND VAD WAS STOPPED ON (B)(6) 2016 AFTER DISCUSSION WITH HIS FAMILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323262 HEARTWARE INC. LVAD HEARTWARE LVAD DSQ HEARTWARE INC

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death