BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 1072311 · Received July 10, 2008

    Report

    Report Number
    2182208-2008-00217
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    February 20, 2008
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    INVALID DATA

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 6943 IMPLANTABLE TACHY LEAD| 7276 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6940 IMPLANTABLE PACING LEAD