BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 3020263 · Received March 25, 2013

    Report

    Report Number
    6000034-2013-00574
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 7, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT WITH DEVICE USE. THE PROCESSOR WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS, AND REPLACEMENT EQUIPMENT WAS PROVIDED. NO REPORTS OF PATIENT INJURY ARE ASSOCIATED WITH EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121505 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM MCM COCHLEAR LTD. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR