BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4222470 · Received October 31, 2014

    Report

    Report Number
    2916596-2014-01951
    Event Type
    Death
    Date Received
    October 31, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INFO PROVIDED, THE LVAD PUMP WILL NOT BE RETURNING FOR EVALUATION. 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 PRESENTED TO THE EMERGENCY DEPT CONFUSED AND AGITATED. THE INTERNATIONAL NORMALIZED RATIO (INR) LEVEL WAS 7.2 AT THE TIME OF ADMISSION. A CAT SCAN (CT) WAS PERFORMED REVEALING A MASSIVE INTRACRANIAL HEMORRHAGE WITH SHIFT. A CRANIOTOMY WAS PERFORMED AND THE PT IS NOT EXPECTED TO SURVIVE THIS EVENT. NO ALARMS WERE REPORTED. PT WILL BE PLACED ON COMFORT CARE. INFO WAS RECEIVED APPROXIMATELY 27 DAYS LATER INDICATING THAT THE PT EXPIRED ON (B)(6) 2014. THE PUMP WILL NOT BE EXPLANTED AND AN AUTOPSY WILL NOT BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698113 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 142206

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death