BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1191161 · Received September 26, 2008

    Report

    Report Number
    3006556115-2008-00506
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 2, 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 PT HAS REPORTED EXPERIENCING PAIN AND INTERMITTENCIES WITH HER INTERNAL DEVICE, FOLLOWED BY A LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE ATTEMPTED, HOWEVER, THIS DID NOT RESOLVE THE PROBLEM. THE PT'S DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER ADVANCED BIONICS COCHLEAR IMPLANT.

    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 60 YR