BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 512986 · Received February 12, 2004

    Report

    Report Number
    MW1031176
    Event Type
    Malfunction
    Date Received
    February 12, 2004
    Date of Event
    January 7, 2004
    Report Date
    February 12, 2004
    Manufacturer
    *
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH SIGNIFICANT MR/METALLIC VALVE X MANY YRS. SURGEON BEGAN TO PUT IN SUTURES IN PREPARATION FOR ST. JUDE VALVE AND THEN CHANGED HIS MIND-REQUESTED A MEDTRONIC MOSAIC VALVE. PACKAGING FOR BOTH PRODUCTS VERY SIMILAR IE: COLOR. MEDTRONIC PRINT VERY SMALL AND HARD TO READ. STAFF REPORTED IT IS EASY TO MISTAKE THE TWO PRODUCTS BECAUSE OF THE COLOR CODING. VALVE INDENTIFIER ON PACKAGING VERY SMALL-"M" OR "A" IS PRINTED ON BOX AND IS NOT EASILY SEEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MOSAIC PORCINE HEART VALVE LWR * 305 29 MM 29M6598361

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR