BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS BIOPROSTHESIS

    MDR report key: 1013156 · Received March 14, 2008

    Report

    Report Number
    6000002-2008-06222
    Event Type
    Death
    Date Received
    March 14, 2008
    Date of Event
    November 1, 2007
    Report Date
    February 26, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED IN 2007. IT IS UNKNOWN IF THE PT'S DEMISE WAS ATTRIBUTED TO THE DEVICE. REPORTEDLY, THE DEVICE WAS IMPLANTED ON THE SAME DAY. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS BIOPROSTHESIS REPLACEMENT VALVE LWR EDWARDS LIFESCIENCES 262521MM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| R