BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2972935 · Received February 21, 2013

    Report

    Report Number
    6000034-2013-00279
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Report Date
    February 23, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED JULY 10, 2013. DEVICE NOT AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE RECHARGEABLE BATTERY OF THE SOUND PROCESSOR WAS FOUND TO HAVE LEAKED (DATE NOT REPORTED). IT WAS ALSO REPORTED THAT THE PATIENT WAS BURNED BY BATTERY FLUID. THE NATURE OF THE BURN AND ANY POSSIBLE MEDICAL INTERVENTIONS PERFORMED WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT, (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76251 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention