BEUDAMED
    FDA Adverse Event Other Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 315784 · Received February 14, 2001

    Report

    Report Number
    315784
    Event Type
    Other
    Date Received
    February 14, 2001
    Date of Event
    January 23, 2001
    Report Date
    February 1, 2001
    Manufacturer
    ST. JUDE MEDICAL INC.
    Product Code
    LWQ
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    VALVE WAS IMPLANTED. UNABLE TO COME OFF BYPASS. MD OPENED ATRIUM & TRIMMED BACK THE SUTURE (THOUGHT TO BE OCCLUDING LEAFLET.) AGAIN UNABLE TO COME OFF BYPASS. THE TEE SHOWED ONLY ONE LEAFLET TO BE MOVING. VALVE EXPLANTED. A CARBONMEDIC VALVE WAS THEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5706 ST. JUDE MEDICAL MECHANIC HEART VALVE LWQ ST. JUDE MEDICAL INC. 29MECJ-502 *

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other