BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 715934 · Received November 18, 2005

    Report

    Report Number
    2029203-2005-00482
    Event Type
    Malfunction
    Date Received
    November 18, 2005
    Date of Event
    October 21, 2005
    Report Date
    November 18, 2005
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    WHILE WEARING THE EXTERNAL EQUIPMENT, THE PT REPORTEDLY HAD NO SOUND PERCEPTION. ON OCTOBER 21, 2005, THE PT WAS SEEN BY A COMPANY REPRESENTATIVE FOR DEVICE EVALUATION. TESTING PERFORMED CONFIRMED THAT THE DEVICE WAS NOT FULLY FUNCTIONAL. SURGERY TO EXPLANT THE PT'S DEVICE IS TO BE 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 89 YR