BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 780539 · Received September 5, 2006

    Report

    Report Number
    2029203-2006-00613
    Event Type
    Malfunction
    Date Received
    September 5, 2006
    Date of Event
    August 14, 2006
    Report Date
    September 5, 2006
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    WHILE WEARING THE EXTERNAL EQUIPMENT, THE PT REPORTEDLY EXPERIENCED INTERMITTENCIES. ON AUGUST 14, 2006, THE PT WAS SEEN BY A COMPANY REP FOR DEVICE EVALUATION. TESTING PERFORMED CONFIRMED THE DEVICE WAS NOT FUNCTIONING. 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 38 YR