BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2231937 · Received September 1, 2011

    Report

    Report Number
    6000034-2011-00647
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    August 10, 2011
    Report Date
    March 5, 2012
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED (B)(4), 2012.

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6), 2011; DURING THE SAME SURGERY THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE. THIS REPORT IS FILED (B)(4), 2011.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT DATE OF EXPLANT/REIMPLANTATION SURGERY WAS (B)(6) 2011; NOT (B)(6) 2011 AS PREVIOUSLY REPORTED.THIS REPORT IS FILED (B)(6) 2011.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED POOR PERFORMANCE WITH THE DEVICE AND FACIAL NERVE STIMULATION RESULTING IN DEVICE NON-USE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE BUT THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT, (B)(6) 2011.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention