BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ST JUDE MEDICAL

    MDR report key: 1031745 · Received April 18, 2008

    Report

    Report Number
    1031745
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    February 25, 2008
    Report Date
    April 18, 2008
    Manufacturer
    ST JUDE MEDICAL INC
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    VALVE WAS PLACED IN PT AND WAS OBSERVED TO NOT BE WORKING PROPERLY. REMOVED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL VALVE LWQ ST JUDE MEDICAL INC 23AHPJ-505

    Patients

    Seq Age Sex Outcome Treatment
    1