BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC HEART VALVE

    MDR report key: 841912 · Received April 20, 2007

    Report

    Report Number
    MW1042666
    Event Type
    Other
    Date Received
    April 20, 2007
    Date of Event
    April 5, 2007
    Report Date
    April 20, 2007
    Manufacturer
    MEDTRONIC HEART VALVES
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NOTIFIED OF THIS EVENT ON 04/13/07. IN 2007, SURGEON REMOVED AND REPLACED THE PROSTHETIC AORTIC VALVE THAT HAD BEEN IMPLANTED IN 2005. THE PRE-OP DIAGNOSIS WAS AORTIC REGURGITATION AND PROSTHETIC VALVE AND ROOT ENDOCARDITIS. POST-OP DIAGNOSIS THE SAME. THE SURGEON WHO REMOVED THIS VALVE STATED "THE VALVE WAS BADLY DESTROYED AND THE PORCINE AORTIC WALL HAD DETERIORATED UNDER THE INVOLVED AREA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC HEART VALVE FREESTYLE AORTIC ROOT HEART VALVE LWR MEDTRONIC HEART VALVES * 8037290

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other