BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSGROVE-EDWARDS ANNULOPLASTY SYSTEM

    MDR report key: 1060469 · Received June 13, 2008

    Report

    Report Number
    6000002-2008-07568
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    April 23, 2008
    Report Date
    May 19, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K923367
    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

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED IN 2008 AFTER AN IMPLANT DURATION OF 112 MONTHS DUE TO UNK REASON. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSGROVE-EDWARDS ANNULOPLASTY SYSTEM ANNULOPLASTY SYSTEM KRH EDWARDS LIFESCIENCES 4600 8L1498

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention