BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2800827 · Received October 17, 2012

    Report

    Report Number
    3006556115-2012-00461
    Event Type
    Injury
    Date Received
    October 17, 2012
    Report Date
    September 27, 2012
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS MADE AWARE THAT THE PT'S ELECTRODE ARRAY HAD MIGRATED OUT OF THE COCHLEA. REPOSITIONING SURGERY IS UNDER CONSIDERATION. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO AND WILL SUBMIT A SUPPLEMENTAL REPORT ONCE MORE 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