BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1083719 · Received July 28, 2008

    Report

    Report Number
    3006556115-2008-00405
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 1, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT IS REPORTEDLY EXPERIENCING OVERLY LOUD STIMULATION. TESTING OF THE DEVICE SHOWED THAT IT IS FUNCTIONING. SURGERY TO EXPLANT THE PATIENT'S DEVICE HAS BEEN DISCUSSED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION, ONCE MORE INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1