BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 4638311 · Received March 27, 2015

    Report

    Report Number
    6000034-2015-00470
    Event Type
    Malfunction
    Date Received
    March 27, 2015
    Date of Event
    March 5, 2015
    Report Date
    April 28, 2015
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    890027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE MODEL NUMBER IS CI22M; AND NOT CI22 AS PREVIOUSLY REPORTED. CORRECTION: THE PMA NUMBER IS 890027; AND NOT 980027 AS PREVIOUSLY REPORTED. THIS REPORT FILED MAY 15, 2015.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCY WITH DEVICE USE. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED ON (B)(6) 2015, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205479 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