BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 1072248 · Received July 10, 2008

    Report

    Report Number
    2182208-2008-00178
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    April 9, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    INVALID DATA

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSVENE IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6936 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention 43007 IMPLANTABLE PACING LEAD| HM342R29H TISSUE VALVE| 6933 IMPLANTABLE TACHY LEAD| HA25023HD TISSUE VALVE| 43203 IMPLANTABLE PACING LEAD| KDR701 IMPLANTABLE PULSE GENERATOR| 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB