BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1233906 · Received November 13, 2008

    Report

    Report Number
    6000034-2008-00653
    Event Type
    Injury
    Date Received
    November 13, 2008
    Date of Event
    August 1, 2008
    Report Date
    January 12, 2009
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, IN 2008 (ESTIMATED DATE) THE PATIENT FELL CAUSING SWELLING OF THE IMPLANT SITE FOR THREE TO FOUR DAYS. THE INTERNAL MAGNET WAS DISLODGED FROM THE MAGNET POCKET. CURRENTLY, THE PATIENT IS HAVING DIFFICULTY KEEPING THE INTERNAL COIL COMFORTABLY IN PLACE. RETAINER DISKS WERE RECOMMENDED. REVISION SURGERY IS SCHEDULED AT ABOUT THREE MONTHS LATER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Female Required Intervention