BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1213273 · Received October 27, 2008

    Report

    Report Number
    3006556115-2008-00568
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    October 3, 2008
    Report Date
    October 3, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE CO WAS INFORMED THAT THE PT DEVELOPED AN INFECTION AT THE IMPLANT SITE. THE PT CONTINUES TO BE MONITORED BY THE CLINIC. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADDITIONAL INFO AND WILL SUBMIT A SUPPLEMENTAL REPORT ONCE NEW INFO IS OBTAINED.

    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