BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 2833560 · Received October 29, 2012

    Report

    Report Number
    3006556115-2012-00481
    Event Type
    Malfunction
    Date Received
    October 29, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS REPORTEDLY EXPERIENCING SOUND QUALITY ISSUES. DEVICE TESTING REVEALED ABNORMAL RESULTS. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR