BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 698433 · Received April 10, 2006

    Report

    Report Number
    2029203-2006-00178
    Event Type
    Injury
    Date Received
    April 10, 2006
    Date of Event
    March 15, 2006
    Report Date
    April 10, 2006
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    ON MARCH 15, 2006, THE COMPANMY WAS NOTIFIED THAT THE PATIENT'S DEVICE WAS EXPLANTED DUE TO AN INFECTION (ETIOLOGY UNKNOWN).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention