BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2832298 · Received November 14, 2012

    Report

    Report Number
    6000034-2012-02202
    Event Type
    Injury
    Date Received
    November 14, 2012
    Date of Event
    November 8, 2012
    Report Date
    July 30, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, SURGERY TO CORRECT THE MAGNET POSITION HAS BEEN COMPLETED ON (B)(4), 2012.THIS REPORT IS FILED JULY 31, 2013. IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED MAGNET DISLODGEMENT DURING MRI (1.5 TESLA). THE PATIENT'S HEAD WAS WRAPPED AS AN APPROVED INDICATION IN EUROPE. SURGERY TO REPLACE THE MAGNET IS PLANNED BUT HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT, (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 CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention