BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1161671 · Received September 15, 2008

    Report

    Report Number
    6000034-2008-00527
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 11, 2008
    Report Date
    September 1, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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 THE PATIENT REPORTED "FEELING" AT THE IMPLANT SITE RATHER THAN HEARING WHEN THE IMPLANT WAS STIMULATED. RESULTS OF INTEGRITY TESTS DONE IN 2008 AND ABOUT 21 DAYS LATER, SHOWED NORMAL RECEIVER/STIMULATOR FUNCTION AND OUTPUT ON ALL ELECTRODES. RECOMMENDATIONS WERE MADE FOR REPROGRAMMING THE SOUND PROCESSOR. HOWEVER THE PROBLEM WAS NOT RESOLVED. THE PATIENT'S DEVICE WAS EXPLANTED AT ABOUT APPROX 96 DAYS LATER, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD. CI24RE(CA) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention