BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 916873 · Received September 21, 2007

    Report

    Report Number
    2029203-2007-00941
    Event Type
    Injury
    Date Received
    September 21, 2007
    Date of Event
    September 5, 2007
    Report Date
    September 5, 2007
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY DEVELOPED OTITIS MEDIA AND WAS PRESCRIBED ANTIBIOTICS (TYPE UNK). TESTING SHOWED POOR NRI RESULTS. AN XRAY SHOWED FULL INSERTION OF THE ELECTRODE ARRAY. THE PATIENT IS BEING EVALUATED FOR POSSIBLE PE TUBE PLACEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention