BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 2091122 · Received May 6, 2011

    Report

    Report Number
    3006556115-2011-00201
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    ADVANCED BIONICS, LLC.
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT IS REPORTEDLY EXPERIENCING A DECREASE IN PERFORMANCE. THE PT REMOVES THE EXTERNAL EQUIPMENT AND REPORTS LOUD SOUNDS AND PAIN. TESTING REVEALED THAT THE DEVICE IS FUNCTIONING. THE PT'S FAMILY AND SURGEON ARE PURSUING DEVICE REVISION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR