BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 4532264 · Received February 20, 2015

    Report

    Report Number
    6000034-2015-00164
    Event Type
    Malfunction
    Date Received
    February 20, 2015
    Date of Event
    January 22, 2015
    Report Date
    May 5, 2015
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    890027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS CURRENTLY UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT PMA NUMBER IS 890027; NOT 840024 AS PREVIOUSLY REPORTED. THIS REPORT FILED JULY 31, 2015.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED DISCOMFORT WITH DEVICE USE. SUBSEQUENTLY THE DEVICE WAS EXPLANTED (B)(6) 2015, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT, JANUARY 20, 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121494 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD . CI22M

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention