BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3093301 · Received May 6, 2013

    Report

    Report Number
    6000034-2013-00832
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    November 13, 2009
    Report Date
    November 20, 2009
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE RECHARGEABLE BATTERY FOR THE SOUND PROCESSOR WAS FOUND TO HAVE WARMED UP WITHOUT BEING IN USE. THE EQUIPMENT HAS BEEN REMOVED FROM SERVICE. NO REPORTS OF PATIENT INJURY ARE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196427 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD. SP12

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention