BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 2830835 · Received November 13, 2012

    Report

    Report Number
    6000034-2012-02168
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    September 28, 2012
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS FOUND TO HAVE BECOME HOT. THERE ARE NO ALLEGATIONS OF PATIENT INJURY ASSOCIATED WITH THIS COMPLAINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN PROVIDED AS OF THE DATE OF THIS REPORT, (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM MCM COCHLEAR LTD. N/A L000020824

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention