BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3971474 · Received July 31, 2014

    Report

    Report Number
    6000034-2014-01083
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    September 22, 2014
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THIS REPORT FILED SEPTEMBER 26, 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY LEAKED. THERE WAS NO ALLEGATION OF INJURY ASSOCIATED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447373 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD . CP800 ACCESSORIE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention