BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 1930773 · Received December 16, 2010

    Report

    Report Number
    6000034-2010-00789
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE HAD MIGRATED. REVISION SURGERY TO REPOSITION THE DEVICE OCCURRED ON (B)(6), 2010. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM MCM COCHLEAR LTD CI512 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention