BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1203458 · Received October 17, 2008

    Report

    Report Number
    3006556115-2008-00575
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    August 6, 2008
    Report Date
    September 27, 2008
    Manufacturer
    ADVANCED BIONICS LLC.
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT EXPERIENCED INTERMITTENCY. THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT WAS RE-IMPLANTED 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-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR