BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3041614 · Received April 8, 2013

    Report

    Report Number
    6000034-2013-00649
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    May 21, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2013; THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AT A LATER DATE (DATE NOT REPORTED). THIS REPORT IS FILED (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON JULY 5, 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT INTERNAL ELECTRODE LEAD WAS FOUND TO HAVE EXTRUDED INTO THE EXTERNAL AUDITORY CANAL (DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS. THERE ARE PLANS TO EXPLANT THE DEVICE; HOWEVER, IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT, (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143828 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24R (CS)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention