BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 499883 · Received November 26, 2003

    Report

    Report Number
    2029203-2003-00234
    Event Type
    Malfunction
    Date Received
    November 26, 2003
    Date of Event
    November 6, 2003
    Report Date
    November 26, 2003
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2003, THE PATIENT'S DEVICE REPORTEDLY STOPPED WORKING. THE PATIENT WAS SEEN BY A COMPANY REPRESENTATIVE FOR DEVICE EVALUATION. EXTERNAL EQUIPMENT WAS EXCHANGED. TESTING WAS NOT CONCLUSIVE. THE PATIENT WAS ABLE TO HEAR DURING TESTING BUT NOT IN LIVE SPEECH/STAND-ALONE. FOUR DAYS LATER, THE PATIENT WAS SEEN AGAIN; PROGRAMMING ADJUSTMENTS WERE MADE. THE PATIENT WAS ABLE TO HEAR IN LIVE SPEECH/STAND-ALONE. THREE WEEKS LATER, THE PATIENT'S DEVICE REPORTEDLY FUNCTIONED INTERMITTENTLY. THE NEXT DAY, THE DETERMINATION WAS MADE THAT THIS DEVICE WAS NOT FUNCTIONING, SURGERY TO EXPLANT THE PATIENT'S DEVICE HAS BEEN SCHEDULED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR