BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 2082657 · Received May 2, 2011

    Report

    Report Number
    3006556115-2011-00196
    Event Type
    Malfunction
    Date Received
    May 2, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 11, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED PAIN, VERTIGO, AND FACIAL NERVE STIMULATION WHILE USING THE DEVICE. THE PATIENT WAS PRESCRIBED MEDICATION TO TREAT THE VERTIGO. THE PATIENT LATER EXPERIENCED SOUND QUALITY ISSUES. THE PATIENT CONTINUES TO BE MONITORED.

    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 67 YR