BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1021441 · Received March 24, 2008

    Report

    Report Number
    3006556115-2008-00138
    Event Type
    Malfunction
    Date Received
    March 24, 2008
    Date of Event
    February 28, 2008
    Report Date
    February 28, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE PT IS REPORTEDLY EXPERIENCING INTERMITTENCIES WITH THE DEVICE. THE EXTERNAL EQUIPMENT WAS REPLACED AND PROGRAMMING ADJUSTMENTS WERE MADE, HOWEVER THE PROBLEM WAS NOT RESOLVED. TESTING PERFORMED BY THE CENTER CONFIRMED THAT THE DEVICE WAS NOT FUNCTIONING. SURGERY TO EXPLANT THE PT'S 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