BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRIO

    MDR report key: 514404 · Received March 5, 2004

    Report

    Report Number
    2182863-2004-00014
    Event Type
    Death
    Date Received
    March 5, 2004
    Date of Event
    July 26, 2003
    Report Date
    March 5, 2004
    Manufacturer
    ELA MEDICAL, S.A.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ELA MEDICAL INC. RECEIVED INFO IN FEBRUARY 2004 THAT THIS PT PASSED AWAY IN 2003. IT WAS REPORTED THAT ALLEGEDLY THIS PACEMAKER CAUSED OR CONTRIBUTED TO THE PT'S DEATH. IT WAS ALSO REPORTED THAT THE PT ALLEGEDLY HAD BEEN HAVING PROBLEM WITH THE PACEMAKER AND THE CORONER HAD WRITTEN THE CAUSE OF DEATH AS "PACEMAKER FAILAURE, FROM HISTORY." IN ADDITION, THE EMT NOTED THAT THIS DEVICE WAS NOT CAPTURING THE PT'S HEART, HOWEVER, THE EMT DID NOT ARRIVE UNTIL AFTER THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIO CARDIAC PACEMAKER DXY ELA MEDICAL, S.A. 112 S020418

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R