BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SURGERY

    MDR report key: 1070912 · Received July 3, 2008

    Report

    Report Number
    6000034-2008-00367
    Event Type
    Injury
    Date Received
    July 3, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 5, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FILED ON JULY 03, 2008.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PT DID NOT RESPOND TO STIMULATION ON MULTIPLE ELECTRODES DURING INITIAL ACTIVATION OF THE COCHLEAR IMPLANT SYSTEM. AN X-RAY CONFIRMED THAT THE ELECTRODE ARRAY WAS NOT SUCCESSFULLY PLACED INTO THE COCHLEA DURING THE INITIAL SURGERY. THE PT WAS SCHEDULED FOR EXPLANATION/REIMPLANTATION SURGERY IN 2008.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention