BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3920988 · Received July 9, 2014

    Report

    Report Number
    6000034-2014-00910
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 23, 2014
    Report Date
    June 13, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2014 DUE TO OTITIS COMPLICATED BY LABYRINTHITIS RESULTING IN DEVICE NON-USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401354 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention