BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1404269 · Received June 21, 2009

    Report

    Report Number
    6000034-2009-00419
    Event Type
    Malfunction
    Date Received
    June 21, 2009
    Date of Event
    March 17, 2009
    Report Date
    May 27, 2009
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PATIENT EXPERIENCED A DECREASE IN PERFORMANCE. THE RESULTS OF AN INTEGRITY TEST 2009, INDICATE MULTIPLE ELECTRODE ANOMALIES. EXPLANT AND REIMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT JUNE 19, 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24R (CS) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention