BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT II

    MDR report key: 505677 · Received January 9, 2004

    Report

    Report Number
    2182863-2004-00005
    Event Type
    Injury
    Date Received
    January 9, 2004
    Date of Event
    February 26, 2003
    Report Date
    January 9, 2004
    Manufacturer
    ELA MEDICAL, S.A.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER 2-MONTHS OF IMPLANTATION, THIS PACEMAKER WAS EXPLANTED BECAUSE OF AN INFECTION. ELA MEDICAL, INC. WAS NOT AWARE OF THIS CASE UNTIL DECEMBER 12, 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT II CARDIAC PACEMAKER DXY ELA MEDICAL, S.A. 133 S020703

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R