BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1021419 · Received March 24, 2008

    Report

    Report Number
    3006556115-2008-00124
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 25, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT HAS REPORTEDLY EXPERIENCED INTERMITTENT SOUND WITH THE DEVICE. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER, THE PROBLEM WAS NOT RESOLVED. SURGERY TO EXPLANT THE DEVICE WILL BE SCHEDULED.

    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