BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENE

    MDR report key: 630775 · Received January 9, 2004

    Report

    Report Number
    2182208-2003-00390
    Event Type
    Injury
    Date Received
    January 9, 2004
    Date of Event
    November 19, 2003
    Manufacturer
    MEDTRONIC INC., CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    Removal / Correction Number
    NI
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    NOISE ON V LEAD, INAPPROPRIATE SHOCKS. SUSPECT INSULATION FAILURE

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other