BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 4542871 · Received February 24, 2015

    Report

    Report Number
    6000034-2015-00197
    Event Type
    Malfunction
    Date Received
    February 24, 2015
    Date of Event
    December 9, 2014
    Report Date
    March 1, 2016
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    890027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT AVAILABLE FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT PMA/510(K) NUMBER IS 890027; NOT 980024 AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A DECREASE IN PERFORMANCE WITH DEVICE USE. THE DEVICE WAS EXPLANTED ON (B)(6) 2014, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128618 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD . CI22M

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention