BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS BIOPROSTHESIS

    MDR report key: 1083255 · Received July 24, 2008

    Report

    Report Number
    6000002-2008-08195
    Event Type
    Death
    Date Received
    July 24, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 16, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P870056
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS EXPIRED. THE DATE OF PTS' DEATH AND IMPLANT DURATION ARE UNK, THEREFORE THE AWARE DATE IS BEING USED AS THE OCCURENCE DATE. IT IS UNK IF THE DEATH WAS DEVICE RELATED. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS BIOPROSTHESIS REPLACEMENT HEART VALVE LWR EDWARDS LIFESCIENCES 2625 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death