BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 1072322 · Received July 10, 2008

    Report

    Report Number
    2182208-2008-00218
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    April 2, 2007
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENE IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6937A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention 5076 IMPLANTABLE PACING LEAD| 6931 IMPLANTABLE TACHY LEAD| D154AWG IMPLANTABLE PACEMAKER/CARDIO/DEFIB