BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOCUS

    MDR report key: 469293 · Received July 1, 2003

    Report

    Report Number
    2182863-2003-00036
    Event Type
    Injury
    Date Received
    July 1, 2003
    Date of Event
    April 1, 2003
    Report Date
    July 1, 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 7 YEARS OF IMPLANTATION, THIS LEAD WAS EXPLANTED BECAUSE OF A POCKET INFECTION. NOTE THAT THIS LEAD WAS IMPLANTED 7 YEARS PRIOR TO THE OCCURRENCE OF THE INFECTION. THE PACEMAKER THAT WAS ATTACHED TO THIS WAS IMPLANTED IN 2002. THE PACEMAKER WAS ALSO REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOCUS VENTRICULAR LEAD DTB ELA MEDICAL, INC. T44F S960109

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Hospitalization| R