BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3946073 · Received July 21, 2014

    Report

    Report Number
    6000034-2014-00992
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 28, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED JULY 30, 2014.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE ELECTRODE ARRAY WAS FOUND TO BE PARTIALLY INSERTED. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2014, TO FULLY INSERT THE ELECTRODE ARRAY INTO THE COCHLEA; HOWEVER, THE ATTEMPT WAS NOT SUCCESSFUL RESULTING IN EXPLANTATION OF THE DEVICE. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424624 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention