BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2900541 · Received January 7, 2013

    Report

    Report Number
    6000034-2013-00018
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 20, 2012
    Report Date
    August 8, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT AVAILABLE FOR ANALYSIS. (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED FACIAL NERVE STIMULATION WITH DEVICE USE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. IMAGING (DATE AND TYPE NOT REPORTED), INDICATED MIGRATION OF THE INTERNAL ELECTRODE ARRAY. THE DEVICE WAS EXPLANTED ON (B)(6) 2012. IT IS UNKNOWN IF THE PATIENT HAS BEEN REIMPLANTED WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT, (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7774 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD. CI22M

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention