BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1070629 · Received July 1, 2008

    Report

    Report Number
    6000034-2008-00355
    Event Type
    Malfunction
    Date Received
    July 1, 2008
    Report Date
    April 23, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FILED ON JULY 01,2008.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PATIENT'S PARENTS WERE NOT SATISFIED WITH THE PATIENT'S PERFORMANCE WITH THE COCHLEAR IMPLANT SYSTEM. RESULTS OF AN INTEGRITY TEST DONE IN 2008 WERE CONSISTENT WITH NORMAL RECEIVER/STIMULATOR FUNCTION WITH ELECTRODE ANOMALIES. MORE TESTING WAS REQUESTED WHILE CHANGING THE PATIENT'S SOUND PROCESSING PROGRAM. A REPEAT INTEGRITY TEST DONE TWO MONTHS LATER, WERE CONSISTENT WITH THE FIRST TEST. REIMPLANTATION WAS RECOMMENDED AFTER EXPERT REVIEW OF THE TEST RESULTS. THE PATIENT'S DEVICE WAS EXPLANTED TWO MONTHS LATER, AND A NEW DEVICE WAS REIMPLANTED DURING THE SAME SURGERY.

    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