BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1021066 · Received March 28, 2008

    Report

    Report Number
    6000002-2008-06378
    Event Type
    Other
    Date Received
    March 28, 2008
    Date of Event
    February 11, 2008
    Report Date
    March 4, 2008
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    REPORTEDLY, THE DEVICE WAS EXPLANTED IN 2008 AFTER AN IMPLANT DURATION OF 7 MONTHS DUE TO AN UNK REASON. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE NONE LWR EDWARDS LIFESCIENCES 6900P25MM 7D0757

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention