BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNUPLASTY RING

    MDR report key: 1001888 · Received February 18, 2008

    Report

    Report Number
    6000002-2008-06072
    Event Type
    Death
    Date Received
    February 18, 2008
    Date of Event
    September 24, 2007
    Report Date
    January 16, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, PT EXPIRED APPROX AFTER AN IMPLANT DURATION OF 0.2 MOS (IN 2007, AFTER AN IMPLANT DATE OF SIX DAYS 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-MCCARTHY-ADAMS IMR ETLOGIX ANNUPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4100 7E1119

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death