BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1021238 · Received March 24, 2008

    Report

    Report Number
    3006556115-2008-00145
    Event Type
    Injury
    Date Received
    March 24, 2008
    Date of Event
    February 26, 2008
    Report Date
    February 26, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE PATIENT IS REPORTEDLY EXPERIENCING POST-OPERATIVE TINNITUS. THE COMPANY WAS INFORMED THAT THE PATIENT'S TINNITUS IS ALWAYS PRESENT, HOWEVER, IT IS LOWER WHEN THE PATIENT'S EXTERNAL EQUIPMENT IS SWITCHED ON. THE DECISION TO TREAT THE PATIENT'S TINNITUS WITH TRANSCRANIAL DIRECT CURRENT STIMULATION IS BEING EVALUATED. ADVANCED BIONICS IS CURRENTLY IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. WHEN MORE INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention