BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1902472 · Received November 10, 2010

    Report

    Report Number
    3006556115-2010-00550
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    January 1, 2008
    Report Date
    October 20, 2010
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT UNDERWENT SURGERY TO REPOSITION THE PATIENT'S INTERNAL DEVICE. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADDITIONAL INFORMATION AND WILL SUBMIT A SUPPLEMENTAL REPORT ONCE NEW INFORMATION IS OBTAINED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention