BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1140553 · Received August 28, 2008

    Report

    Report Number
    3006556115-2008-00427
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 2008
    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 REPORTEDLY EXPERIENCED A DECREASE IN SOUND PERFORMANCE. TESTING OF THE DEVICE SHOWED THAT IT IS FUNCTIONING. THE PATIENT'S DEVICE WAS EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1