BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST JUDE MEDICAL

    MDR report key: 2581408 · Received May 15, 2012

    Report

    Report Number
    MW5025437
    Event Type
    Malfunction
    Date Received
    May 15, 2012
    Date of Event
    May 14, 2012
    Report Date
    May 15, 2012
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    R WAVE MEASUREMENT OF THIS CHRONIC LEAD WENT FROM 6.6MV ON (B)(6) 2012 TO 2.1 MV ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL DURATA STS OPTIMA LWS ST JUDE MEDICAL 7121 BJX11657

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR