BEUDAMED
    FDA Adverse Event Other Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 748873 · Received August 16, 2005

    Report

    Report Number
    MW1036345
    Event Type
    Other
    Date Received
    August 16, 2005
    Date of Event
    August 12, 2005
    Report Date
    August 15, 2005
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AORTIC VALVE ST. JUDE 17MM WAS COMPLETELY SEWN IN PLACE WHEN THE LEAFLET BROKE OFF. VALVE WAS REMOVED, I REPLACED WITH NEW VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL AORTIC VALVE LWQ ST. JUDE MEDICAL 17 AHP - 105 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other