BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRIO

    MDR report key: 501501 · Received December 16, 2003

    Report

    Report Number
    2182863-2003-00065
    Event Type
    Injury
    Date Received
    December 16, 2003
    Date of Event
    September 17, 2001
    Report Date
    December 16, 2003
    Manufacturer
    ELA MEDICAL, S.A.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER 11+ MONTHS OF IMPLANTATION, THIS PACEMAKER WAS EXPLANTED BECAUSE OF AN INFECTION. NOTE: ELA MEDICAL, INC. WAS NOT AWARE OF THIS CASE UNTIL 11/17/03.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R