BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 796932 · Received December 12, 2006

    Report

    Report Number
    6000034-2006-00471
    Event Type
    Malfunction
    Date Received
    December 12, 2006
    Date of Event
    May 17, 2006
    Report Date
    December 12, 2006
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST'S REPORT, THIS PT DEVELOPED AN INCREASING NUMBER OF FAULTY ELECTRODES AND A DECREASE IN PERFORMANCE. INTEGRITY TESTING PERFORMED ON 11/14/2006 CONFIRMED THE ELECTRODE FAULTS. HIS SURGEON EXPLANTED THE DEVICE IN 2006 AND REIMPLANTED A NEW DEVICE THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM COCHLEAR LTD. CI24R(ST) *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention