BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2882871 · Received December 21, 2012

    Report

    Report Number
    6000034-2012-02360
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    December 5, 2012
    Report Date
    September 10, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED DECEMBER 12, 2013.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED DISCOMFORT DUE TO WARM SENSATION WITH EXTERNAL DEVICE USE.ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE 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 SP12

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention