BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3230278 · Received July 16, 2013

    Report

    Report Number
    6000034-2013-01300
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    July 10, 2013
    Report Date
    July 12, 2013
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT'S DEVICE HAS MIGRATED SINCE IMPLANTATION. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013 TO HAVE THE DEVICE REPOSITIONED. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329856 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD . CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention