BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STELA

    MDR report key: 501308 · Received December 16, 2003

    Report

    Report Number
    2182863-2003-00066
    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
    DTB
    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 LEAD WAS EXPLANTED BECAUSE OF AN INFECTION. ELA MEDICAL, INC. WAS NOT AWARE OF THIS CASE UNTIL 11/17/03. NOTE: THE PACEMAKER THAT WAS ATTACHED TO THIS LEAD WAS ALSO REMOVED AND REPORTED ON AN MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STELA VENTRICULAR LEAD DTB ELA MEDICAL, S.A. BT46 H000512

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R