BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2771303 · Received October 4, 2012

    Report

    Report Number
    6000034-2012-01913
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    July 30, 2012
    Report Date
    August 7, 2012
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED MAGNET DISLODGEMENT. SURGERY TO REPLACE THE MAGNET HAS BEEN COMPLETED ON (B)(6), 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24M

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention