BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 712363 · Received May 9, 2006

    Report

    Report Number
    2029203-2006-00247
    Event Type
    Malfunction
    Date Received
    May 9, 2006
    Date of Event
    April 12, 2006
    Report Date
    May 9, 2006
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED NO LOCK BETWEN THE EXTERNAL EQUIPMENT AND THE COCHLEAR IMPLANT. ON APRIL 14, 2006, THE PATIENT WAS SEEN BY A COMPANY REPRESENTATIVE FOR DEVICE EVALUATION. TESTING PERFORMED CONFIRMED THAT THE DEVICE WAS NO LONGER FUNCTIONING. SURGERY TO EXPLANT THE PATIENT'S DVEICE IS TO BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS CORPORATION CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 MO