BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1832865 · Received September 13, 2010

    Report

    Report Number
    6000034-2010-00610
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    September 10, 2010
    Report Date
    February 14, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED OTITIS MEDIA AND A CHOLESTEATOMA IN THE IMPLANTED EAR. THE DEVICE WAS EXPLANTED ON (B)(6), 2010 AND THE PATIENT WAS IMPLANTED WITH A NEW DEVICE ON THE IPSILATERAL SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24R (CS) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention