BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 2091157 · Received May 10, 2011

    Report

    Report Number
    3006556115-2011-00222
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT IS REPORTEDLY EXPERIENCING SOUND QUALITY ISSUES AND INTERMITTENCIES. TESTING OF THE DEVICE SHOWED OPEN IMPEDANCES ON ALL ELECTRODES. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO.

    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 49 YR