BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1151408 · Received September 4, 2008

    Report

    Report Number
    3006556115-2008-00468
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    May 8, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT HAD MASTOIDITIS. THE PATIENT'S DEVICE WAS EXPLANTED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION, AND WILL SUBMIT A FOLLOW-UP REPORT.

    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