BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

    MDR report key: 1000166 · Received February 18, 2008

    Report

    Report Number
    6000002-2008-06074
    Event Type
    Death
    Date Received
    February 18, 2008
    Date of Event
    December 13, 2007
    Report Date
    January 16, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, PT EXPIRED APPROX AFTER AN IMPLANT DURATION OF 2.13 MONTHS (IN 2007, AFTER AN IMPLANT DATE OF APPROX TWO MONTHS EARLIER), DUE TO UNK REASONS. UNK IF PT DEATH IS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4500 07D096

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death