BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2413079 · Received January 10, 2012

    Report

    Report Number
    2916596-2012-00031
    Event Type
    Death
    Date Received
    January 10, 2012
    Date of Event
    December 15, 2011
    Report Date
    December 15, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'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 OUT TO DINNER WITH FAMILY AND WALKED AHEAD TO GET TO THE CAR. WHEN THE FAMILY ARRIVED AT THE CAR, THEY FOUND HIM PASSED OUT IN BACK SEAT OF THE CAR, WITH A "RED HEART" ALARM, AND THE WHITE POWER LEAD DISCONNECTED. EMERGENCY SERVICES WAS CALLED AND ARRIVED ON SCENE QUICKLY. THE PT WAS FOUND IN VENTRICULAR FIBRILLATION (VF), CPR WAS PERFORMED AND THE PT WAS TAKEN TO THE ER WHERE HE WAS SEDATED AND INTUBATED WITH CEREBRAL COOLING. AT THAT TIME, PUPILS WERE EQUAL AND REACTING, COMPUTED TOPOGRAPHY (CT) HAD NO ABNORMALITIES DETECTED AND ELECTROENCEPHALOGRAM (EEG) SHOWED DECREASED ACTIVITY. IT WAS NOTED THAT THE PT WAS ON THE ORIGINAL SYSTEM CONTROLLER WHICH SEEMED TO BE FUNCTIONING FINE WITH BOTH POWER LEADS CONNECTED AND WORKING. IT WAS THOUGH THAT PERHAPS THE PT HAD VF ARREST, PANICKED AND TRIED TO CHANGE BOTH BATTERIES AND ACCIDENTALLY DISCONNECTED BOTH. THE PT CONTINUED TO BE MONITORED, HOWEVER IT WAS REPORTED THAT 7 DAYS LATER SUPPORT WAS WITHDRAWN DUE TO NO NEUROLOGICAL FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 92459

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death| R