BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1150473 · Received September 5, 2008

    Report

    Report Number
    6000034-2008-00496
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    September 1, 2007
    Report Date
    August 7, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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'S REPORT IN 2008, THE PT DEVELOPED A SKIN FLAP INFECTION IN 2007. MEDICATION DID NOT SOLVE THE PROBLEM. DURING A REVISION SURGERY TO REMOVE THE GRANULATED INFECTED TISSUE, THE ELECTRODE ARRAY WAS PULLED PARTIALLY OUT OF THE COCHLEA. THE SURGEON WAS UNABLE TO REINSERT THE ARRAY DUE TO "A LOT" OF FIBROTIC TISSUE AROUND THE ARRAY. DUE TO THE RISK OF FURTHER INFECTION, THE PT'S OLD DEVICE WAS LEFT IN PLACE AND HE WAS IMPLANTED WITH A NEW DEVICE IN THE CONTRALATERAL EAR ON ORIGINAL DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD. CI24R(ST) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention