BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT II

    MDR report key: 540993 · Received August 29, 2004

    Report

    Report Number
    2182863-2004-00051
    Event Type
    Injury
    Date Received
    August 29, 2004
    Date of Event
    September 18, 2003
    Report Date
    August 29, 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 1+ MONTHS OF IMPLANTATION, THIS PACEMAKER WAS REMOVED BECAUSE OF AN INFECTION. ELA MEDICAL, INC. WAS NOT NOTIFIED OF THIS CASE UNTIL AUGUST, 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT II CARDIAC PACEMAKER DXY ELA MEDICAL, S.A. 233 S021112

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R