BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2800826 · Received October 17, 2012

    Report

    Report Number
    3006556115-2012-00456
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 26, 2012
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCES FACIAL NERVE STIMULATION (FNS) IN THE FORM OF EYE TWITCHING DURING USE OF HER COCHLEAR IMPLANT DEVICE ON THE IPSILATERAL EAR. EXTENSIVE PROGRAMMING ADJUSTMENTS WERE MADE. THE PROBLEM WAS NOT RESOLVED. THE PT RECEIVED BOTOX INJECTION TO BE FOLLOWED BY ADD¿L DEVICE PROGRAMMING. ONCE MORE INFO BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention