BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 2231626 · Received August 15, 2011

    Report

    Report Number
    3006556115-2011-00395
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 25, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED INTERMITTENCY AND SOUND QUALITY ISSUES BETWEEN THE EXTERNAL EQUIPMENT AND THE COCHLEAR IMPLANT. IT WAS REPORTED THAT THE POWER REQUIREMENTS SEEM TO BE INCREASING. EXTERNAL EQUIPMENT WAS EXCHANGED. PROGRAMMING ADJUSTMENTS WERE MADE. DEVICE TESTING REVEALED THAT THE DEVICE IS FUNCTIONING. THE REPORTED PROBLEM WAS NOT RESOLVED. THE PATIENT HAS DISCONTINUED USE OF HIS EXTERNAL EQUIPMENT. THE PATIENT IS BEING MONITORED BY THE CENTER.

    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 14 YR