BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST JUDE MEDICAL

    MDR report key: 2771606 · Received September 26, 2012

    Report

    Report Number
    MW5027107
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 19, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    GZB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EXTERNALIZED CONDUCTOR NOTED ON FLUORO PERFORMED FOR RECALL RIATA LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL RIATA GZB ST JUDE MEDICAL 1581

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR