BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1131950 · Received August 22, 2008

    Report

    Report Number
    6000034-2008-00476
    Event Type
    Injury
    Date Received
    August 22, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    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 SURGEON, THE PT HAS COCHLEAR ANATOMICAL ABNORMALTIES. A CSF GUSHER OCCURRED DURING SURGERY AND THE SURGEON WAS UNABLE TO GET OPTIMAL ELECTRODE ARRAY PLACEMENT. REPORTEDLY, THE WEEKEND AFTER THE SURGERY, THE PT CONTINUED TO HAVE PROBLEMS WITH A CSF LEAK. THE PT WAS READMITTED TO THE OR AND A LUMBAR DRAIN WAS PLACED. A REVISION SURGERY WAS DONE IN 2008 TO REPOSITION THE DEVICE TO IMPROVE ELECTRODE ARRAY PLACEMENT. RESULTS OF THE REVISION SURGERY HAD NOT BEEN REPORTED AT THE TIME OF THIS REPORT.

    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