BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II

    MDR report key: 3874090 · Received June 11, 2014

    Report

    Report Number
    3874090
    Event Type
    Death
    Date Received
    June 11, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 30, 2014
    Manufacturer
    THORATEC
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS OUT WITH FRIENDS WHEN HE HAD A DEVICE ALARM. NUMBER 911 WAS CALLED AND HIS FRIENDS ATTEMPTED TO CHANGE OUT THE BATTERIES AND CONTROLLER. HE LOST CONSCIOUSNESS AND WAS APNEIC WHEN EMS ARRIVED. HE ARRIVED TO THE ED IN CARDIAC ARREST AND WAS RESUSCITATED WITH RETURN OF SPONTANEOUS CIRCULATION, BUT WAS IN DEEP COMA. EEG MONITORING CONFIRMED SEVERE ANOXIC INJURY WITH WORSENING NEUROLOGIC STATUS. BASED ON HIS PREVIOUSLY EXPRESSED WISHES HE WAS MADE COMFORT MEASURES ONLY AND CTB. INTUBATED IN THE FIELD BY EMS AND SUPPORTED WITH BAG VENTILATION TO ET TUBE. REFERENCE MFR # 2916596-2014-00708.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344249 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC VAD 10035 EPC 8938C

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death BIVENTRICULAR PACEMAKER