BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1083119 · Received July 24, 2008

    Report

    Report Number
    3006556115-2008-00373
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 1, 2008
    Report Date
    June 30, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S DEVICE IS REPORTEDLY SHOWING THAT ALL ELECTRODES ARE SHORTED. THE PATIENT REPORTEDLY EXPERIENCED OVERLY LOUD STIMULATION. TESTING OF THE DEVICE SHOWED THAT IT IS NOT FUNCTIONING. THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.

    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