BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST JUDE MEDICAL

    MDR report key: 282104 · Received June 13, 2000

    Report

    Report Number
    282104
    Event Type
    Death
    Date Received
    June 13, 2000
    Date of Event
    May 22, 2000
    Report Date
    June 12, 2000
    Manufacturer
    ST JUDE MEDICAL INC
    Product Code
    LWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS TAKEN TO O/R FOR REPAIR OF MALFUNCTIONING PROSTHETIC AORTIC VALVE. THE VALVE WAS REPOSITIONED, BUT IT WAS STILL MALFUNCTIONING AT COMPLETION OF THE PROCEDURE. PT WAS REOPENED AND THE VALVE WAS REMOVED AND REPLACED. THE NEW VALVE FUNCTIONED BETTER, BUT THE PT CONTINUED TO DO POORLY. AN IABP WAS INSERTED, BUT THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL AORTIC VALVE LWQ ST JUDE MEDICAL INC ANPJ-505 *

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death