BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1021831 · Received March 27, 2008

    Report

    Report Number
    6000034-2008-00139
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Date of Event
    February 27, 2008
    Report Date
    March 27, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, AN INTEGRITY TEST WAS REQUESTED DUE TO SIGNIFICANT CHANGES NOTED IN THE PATIENT'S ELECTRODE IMPEDANCES. REPORTEDLY, PRIOR TO THE INTEGRITY TEST, THE PATIENT HAD FALLEN REQUIRING HOSPITALIZATION. RESULTS OF INTEGRITY TESTS DONE IN 2007 AND 2008 WERE CONSISTENT WITH NORMAL RECEIVER/STIMULATOR FUNCTION WITH MULTIPLE ANOMALOUS ELECTRODES. THE CLINIC REPORTEDLY PLANS TO OFFER EXPLANT/REIMPLANT SURGERY DUE TO DECREASED PATIENT PERFORMANCE. EXPLANT/REIMPLANT INFORMATION HAD NOT BEEN PROVIDED AT THE TIME OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention