BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1083117 · Received July 24, 2008

    Report

    Report Number
    3006556115-2008-00389
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS REPORTEDLY EXPERIENCING SOUND QUALITY ISSUES WITH HIS INTERNAL DEVICE. EXTERNAL EQUIPMENT HAS BEEN EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE ATTEMPTED; HOWEVER, THIS DID NOT RESOLVE THE PROBLEM. TESTING OF THE DEVICE SHOWED THAT THE DEVICE IS FUNCTIONAL. THE OPTION OF A REVISION SURGERY IS BEING DISCUSSED.

    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