BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 3935004 · Received July 15, 2014

    Report

    Report Number
    6000034-2014-01010
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    July 24, 2014
    Report Date
    October 21, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED FEBRUARY 9TH, 2015.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2014; DURING THE SAME SURGERY, THE PATIENT WAS RE IMPLANTED WITH A NEW DEVICE. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT, (B)(6) 2014. THIS REPORT IS FILED (B)(4) 2014. DEVICE IS CURRENTLY UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES, REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412196 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM MCM COCHLEAR LTD. CI512 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention