BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIO

    MDR report key: 527673 · Received June 2, 2004

    Report

    Report Number
    2182863-2004-00029
    Event Type
    Injury
    Date Received
    June 2, 2004
    Date of Event
    July 28, 2003
    Report Date
    May 2, 2004
    Manufacturer
    ELA MEDICAL, S.A.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER 9+ MONTHS OF IMPLANTATION, THIS PACEMAKER WAS EXPLANTED BECAUSE OF AN INFECTION. NOTE: DURING AN INTERNAL REVIEW PROCESS ELA MEDICAL, INC. DISCOVERED THAT THIS CASE WAS INADVERTENTLY NOT SUBMITTED IN 2003. THEREFORE, THIS MDR IS NOW BEING FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRIO CARDIAC PACEMAKER DXY ELA MEDICAL, S.A. 212 S020318

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R