BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 508812 · Received January 19, 2004

    Report

    Report Number
    MW1030905
    Event Type
    Injury
    Date Received
    January 19, 2004
    Date of Event
    January 12, 2004
    Report Date
    January 19, 2004
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE CARDIOVASCULAR SURGEON WAS INSERTING THE VALVE IT BROKE. ALL PIECES WERE RECOVERED. PT HAD TO REMAIN ON THE BYPASS MACHINE WHILE THE STAFF OBTAINED ANOTHER VALVE FORM A DIFFERENT HOSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL AORTIC SJM REGENT VALVE - ROTATABLE LWQ ST. JUDE MEDICAL 19AGFN-756 *

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R