BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE HVAD

    MDR report key: 6107050 · Received November 7, 2016

    Report

    Report Number
    6107050
    Event Type
    Death
    Date Received
    November 7, 2016
    Date of Event
    October 22, 2016
    Report Date
    November 4, 2016
    Manufacturer
    MEDTRONIC/HEARTWARE
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2016 AT 1453, PT'S SON-IN-LAW CALLED MCS COORDINATOR ON CALL STATING THE PT WAS FOUND DEAD, EMS AND CORONER ON SCENE TO PRONOUNCE PT. PT'S SON-IN-LAW WAS CALLING MCS COORDINATOR TO ASK WHAT TO DO ABOUT THE PUMP BECAUSE THE PT WAS LAYING ON THE PUMP AND IT WAS NOT ALARMING. MCS COORDINATOR SPOKE WITH LOCAL PA WHO WAS ALSO ON SCENE WITH PT AND FAMILY. INSTRUCTED PT'S SON ON HOW TO DISCONNECT CONTROLLER FROM PT'S DRIVELINE SO THAT IT CAN BE SENT TO (B)(6) TO BE INTERROGATED. CONTROLLER REMOVED FROM PT BY SON WITHOUT DIFFICULTY AND GIVEN TO SHERIFF'S OFFICE UNTIL INVESTIGATION IS COMPLETED. PA STATED SHE WOULD GET ALL THE DETAILS OF INCIDENT AND CONTACT MCS COORDINATOR WHEN COMPLETING HER REPORT. ON (B)(6) 2016 AT 1556, PA CALLED MCS COORDINATOR AND DESCRIBED TIMELINE OF EVENTS: (B)(6) - PT C/O BUG BITE THAT HAD BEEN BOTHERING HIM TO FAMILY; (B)(6) 1400: PT NOT FEELING GREAT, GOES TO TAKE A NAP, HE LIVES LONE BUT HIS SISTER AND HER HUSBAND ARE STAYING ON HIS PROPERTY IN MOTOR HOME. PT ASKS SISTER TO WAKE HIM UP AT 1500, THEY HAVE PLANS THIS AFTERNOON; (B)(6) 1445: PT'S SISTER GOES INTO HOUSE, PT IS STILL IN BED; (B)(6) 1500: PT'S BROTHER-IN-LAW GOES INTO HOUSE AND FINDS PT DEAD IN HALLWAY, FACE DOWN WITH "BLOOD EVERYWHERE." NOTHING ON HVAD LVAD IS ALARMING. PA STATES THAT PT'S FAMILY STATED IT LOOKED TO THEM LIKE HE WAS HEADING TOWARD BATTERY CHARGER WHERE HE WOULD NORMALLY GO IF HE WAS CHANGING HIS HVAD BATTERY. PT WAS FOUND WITH NO POWER TO HVAD LVAD AND NO ALARM SOUNDING, WITH ONE BATTERY WITH ONE YELLOW BAR AND UNDER HIM AND ONE BATTERY FULLY CHARGED NEAR BY. LOCAL PA WAS GIVEN PT'S PRIMARY CONTROLLER AND THIS WILL BE SENT TO (B)(6) FOR INTERROGATION, RELEASED BY SHERIFFS DEPT INTO HER POSSESSION AS THERE WAS DETERMINED TO BE NO FOUL PLAY AROUND SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734949 HEARTWARE HVAD HVAD DSQ MEDTRONIC/HEARTWARE 1403US

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death