BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1842309 · Received August 27, 2010

    Report

    Report Number
    3006556115-2010-00408
    Event Type
    Malfunction
    Date Received
    August 27, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS REPORTEDLY EXPERIENCING SOUND QUALITY ISSUES. PROGRAMMING ADJUSTMENTS WERE ATTEMPTED, HOWEVER THIS DID NOT RESOLVE THE ISSUE. THE PATIENT REPORTEDLY HAS EXPERIENCED A DEVICE FAILURE. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION.

    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 4 YR