BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOSAIC

    MDR report key: 1823555 · Received August 24, 2010

    Report

    Report Number
    1823555
    Event Type
    Malfunction
    Date Received
    August 24, 2010
    Date of Event
    July 13, 2010
    Report Date
    August 24, 2010
    Manufacturer
    MEDTRONIC
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    AORTIC HEART VALVE IMPLANTED 3 YEARS AGO. IN 2010 PATIENT DEMONSTRATED SYMPTOMS OF SEVERE AORTIC VALVE INSUFFICIENCY FOR UNKNOWN PERIOD OF TIME. ECHOCARDIOGRAM SHOWED EVIDENCE OF MODERATELY SEVERE PERIVALVULAR AORTIC INSUFFICIENCY. PATIENT UNDERWENT SURGERY FOR RE-REPLACEMENT OF AORTIC VALVE. WHEN VALVE WAS EXPLANTED IT WAS FOUND TO HAVE A 0.6 CM LINEAR DEFECT ON ONE OF THE VALVE CUSPS. PATIENT RECEIVED IMPLANT OF NEW VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOSAIC AORTIC HEART VALVE/PORCINE HEART VALVE 23MM LWR MEDTRONIC 305 *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR