BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3081917 · Received April 29, 2013

    Report

    Report Number
    6000034-2013-00735
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Report Date
    November 19, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED DECEMBER 16, 2013.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE RECHARGEABLE BATTERY OF THE EXTERNAL SOUND PROCESSOR WAS FOUND TO HAVE BECOME HOT (DATE NOT REPORTED). THE EQUIPMENT WAS REMOVED FROM SERVICE AND A REPLACEMENT WAS SENT. NO REPORTS OF PATIENT INJURY ARE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183669 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention