BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING

    MDR report key: 1050211 · Received May 23, 2008

    Report

    Report Number
    6000002-2008-07303
    Event Type
    Death
    Date Received
    May 23, 2008
    Report Date
    April 22, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K032250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED DUE TO UNK REASONS. DATE OF PT'S DEATH AND IMPLANT DURATION ARE UNK. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING ANNULOPLASTY RING KRH EDWARDS LIFESCIENCES 4100 R-07M2470

    Patients

    Seq Age Sex Outcome Treatment
    1 Death