BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELOX 45 BP

    MDR report key: 761587 · Received September 1, 2006

    Report

    Report Number
    1028232-2004-00116
    Event Type
    Injury
    Date Received
    September 1, 2006
    Report Date
    September 14, 2004
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DTB
    PMA / PMN Number
    k994240
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LEAD REMOVED DUE TO INFECTION. PREVIOUSLY REPORTED THROUGH THE IDE SYSTEM. INTERNAL REVIEW REVEALED THAT NO MDR WAS TRANSMITTED. THE OTHER LEAD ASSOCIATED WITH THIS SYSTEM IS A KENTROX RV 65, MDR 1028232-05-0013 AND THE IDE DEVICE, TUPOS LV/ATX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELOX 45 BP PACER LEAD DTB BIOTRONIK GMBH AND CO 342305 *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR