BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST JUDE MEDICAL

    MDR report key: 1010235 · Received February 28, 2008

    Report

    Report Number
    MW5005829
    Event Type
    Injury
    Date Received
    February 28, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 19, 2008
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SENSING MALFUNCTION ON RIGHT VENTRICULAR ICD LEAD CAUSED PT TO GET ICD THERAPY. ON ADVICE FROM REP REGARDING FUTURE POTENTIAL FAILURE, LEAD WAS CAPPED AND NEW LEAD IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL RT VENTRICULAR ICD LEAD LWS 1580

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention