BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELA LEAD

    MDR report key: 500205 · Received December 11, 2003

    Report

    Report Number
    2182863-2003-00062
    Event Type
    Injury
    Date Received
    December 11, 2003
    Date of Event
    August 17, 2003
    Report Date
    December 11, 2003
    Manufacturer
    ELA MEDICAL, INC.
    Product Code
    DTB
    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 LEAD WAS EXPLANTED BECAUSE OF AN INFECTION AND EROSION. NOTE: THE PACEMAKER THAT WAS ATTACHED TO THIS LEAD WAS ALSO REMOVED AND REPORTED ON AN MDR. ELA MEDICAL WAS NOT AWARE OF THIS INCIDENT UNTIL NOVEMBER 13, 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELA LEAD VENTRICULAR LEAD DTB ELA MEDICAL, INC. BT45 H000816

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R