BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1182305 · Received September 30, 2008

    Report

    Report Number
    3006556115-2008-00508
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 9, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT'S DEVICE IS NOT FUNCTIONING. THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR IMPLANT.

    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 10 YR