BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1222435 · Received November 4, 2008

    Report

    Report Number
    3006556115-2008-00542
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 15, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE CO WAS INFORMED THAT THE PT'S ELECTRODE ARRAY HAS MIGRATED OUT OF THE COCHLEA. THE PT UNDERWENT SURGERY TO REPOSITION THE ELECTRODE ARRAY IN 2008. THE PT CONTINUES TO BE MONITORED BY THE CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention