BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 1040253 · Received May 7, 2008

    Report

    Report Number
    6000002-2008-07074
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    September 24, 2007
    Report Date
    October 10, 2007
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    REPORTEDLY, PT EXPIRED AFTER AN IMPLANT DURATION OF 0 DAYS (IN 2007, AFTER AN IMPLANT DATE OF 2007), DUE TO CARDIAC FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4600 R06M0882

    Patients

    Seq Age Sex Outcome Treatment
    1 Death