BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEVICE #1 TALENT

    MDR report key: 500202 · Received December 11, 2003

    Report

    Report Number
    2182863-2003-00061
    Event Type
    Injury
    Date Received
    December 11, 2003
    Date of Event
    August 17, 2001
    Report Date
    December 11, 2003
    Manufacturer
    ELA MEDICAL, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER 5 MONTHS OF IMPLANTATION, THIS PACEMAKER WAS EXPLANTED BECAUSE OF INFECTION AND EROSION. ELA MEDICAL WAS NOT AWARE OF THIS INCIDENT UNTIL NOVEMBER 13, 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE #1 TALENT CARDIAC PACEMAKER DXY ELA MEDICAL, INC. 213 S010112

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R