BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 2152824 · Received June 27, 2011

    Report

    Report Number
    3006556115-2011-00313
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCES SOUND QUALITY ISSUES AND DECREASED SPEECH PERCEPTION WITH USE OF THE COCHLEAR IMPLANT. EXTENSIVE PROGRAMMING CHANGES WERE MADE. TESTING REVEALED THAT THE DEVICE IS FUNCTIONING WITHIN NORMAL LIMITS. THE CENTER WILL PURSUE DEVICE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR