BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 5852647 · Received August 7, 2016

    Report

    Report Number
    6000034-2016-01601
    Event Type
    Malfunction
    Date Received
    August 7, 2016
    Date of Event
    July 28, 2016
    Report Date
    September 14, 2016
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P840024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED BY COCHLEAR LIMITED (MANUFACTURER) ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. THIS REPORT IS FILED OCTOBER 6, 2016. (B)(4).

    Additional Manufacturer Narrative · 0

    REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. THIS REPORT IS SUBMITTED BY COCHLEAR LIMITED (MANUFACTURER) ON BEHALF OF COCHLEAR AMERICAS. THIS REPORT IS FILED IS FILED ON AUGUST 08, 2016. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT LEADING TO DEVICE NON USE; SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6) 2016. THERE ARE NO PLANS TO RE-IMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504729 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI22M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention