BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEOGORM ANNULOPLASTY RING MITRAL

    MDR report key: 1131905 · Received August 20, 2008

    Report

    Report Number
    6000002-2008-08472
    Event Type
    Injury
    Date Received
    August 20, 2008
    Date of Event
    June 27, 2008
    Report Date
    August 11, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    KRH
    PMA / PMN Number
    K032250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 APPROX AFTER IMPLANT DURATION OF 2 MONTHS, DUE TO UNKNOWN REASONS. NO FURTHER DETAILS WERE PROVIDED. INFO LEARNED FROM IMPLANT PT REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GEOGORM ANNULOPLASTY RING MITRAL ANNULOPASTY RING KRH EDWARDS LIFESCIENCES 4200 R-07H1715

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention