BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3171753 · Received June 17, 2013

    Report

    Report Number
    6000034-2013-01094
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 7, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A MIDDLE EAR INFECTION RESULTING IN THE EXTRUSION OF THE ELECTRODE ARRAY THROUGH THE TYMPANIC MEMBRANE.SURGERY TO RELOCATE THE ARRAY IS PLANNED BUT HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT, (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273906 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention