BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1201748 · Received October 14, 2008

    Report

    Report Number
    6000002-2008-08924
    Event Type
    Injury
    Date Received
    October 14, 2008
    Report Date
    September 22, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE MAY BE EXPLANTED AFTER AN IMPLANT DURATION OF APPROXIMATELY 2 MONTHS DUE TO CENTRAL JET REGURGITATION. REPORTEDLY, THE CARDIOLOGIST IS SENDING AN ECHO FOR REVIEW. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN HEART VALVE REPLACEMENT LWR EDWARDS LIFESCIENCES UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention