BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1153190 · Received September 4, 2008

    Report

    Report Number
    3006556115-2008-00466
    Event Type
    Malfunction
    Date Received
    September 4, 2008
    Date of Event
    May 13, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    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'S INTERNAL DEVICE FAILED. THE PATIENT'S DEVICE WAS EXPLANTED. THE COMPANY IS CURRENTLY IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION. WHEN NEW INFORMATION IS OBTAINED, A SUPPLEMENTAL 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