BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 2091169 · Received May 10, 2011

    Report

    Report Number
    3006556115-2011-00218
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED SOUND QUALITY ISSUES AND DECREASED PERFORMANCE WITH USE OF THE COCHLEAR IMPLANT. EXTENSIVE PROGRAMMING CHANGES WERE MADE, AND EXTERNAL EQUIPMENT HAS BEEN EXCHANGED. HOWEVER, THIS ISSUE HAS NOT BEEN RESOLVED. DEVICE REVISION SURGERY HAS BEEN SCHEDULED.

    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