BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SJM REGENT VALVE

    MDR report key: 1121603 · Received August 8, 2008

    Report

    Report Number
    1121603
    Event Type
    Malfunction
    Date Received
    August 8, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 8, 2008
    Manufacturer
    ST. JUDE CARDIOLOGY
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER PLACEMENT OF THE ST. JUDE AORTIC VALVE, THE DEVICE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM REGENT VALVE VALVE, AORTIC LWQ ST. JUDE CARDIOLOGY 21AGFN-756 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *