BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1455959 · Received August 28, 2009

    Report

    Report Number
    6000034-2009-00586
    Event Type
    Injury
    Date Received
    August 28, 2009
    Date of Event
    July 21, 2009
    Report Date
    July 28, 2009
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PER THE PHYSICIAN, THE PATIENT WAS EXPLANTED IN 2009 DUE TO EXTRUSION OF THE DEVICE. MORE INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME THIS REPORT WAS FILED AUGUST 21, 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24RE (CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention