BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1241513 · Received November 20, 2008

    Report

    Report Number
    6000034-2008-00668
    Event Type
    Injury
    Date Received
    November 20, 2008
    Date of Event
    September 2, 2008
    Report Date
    September 2, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    840024
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, IN 2002, IT WAS NOTED THAT THE RECEIVER/STIMULATOR COULD BE MOVED UNDER THE SKIN. IN 2003, THE PT WAS EVALUATED FOR SURGERY AND A CT SCAN WAS ORDERED. IN 2008, THE PT REPORTED "PAIN, TENDERNESS" AND THAT THE "RECEIVER/STIMULATOR WAS STILL SLIPPING". THE PT ALSO EXPERIENCED DECREASED PERFORMANCE WITH THE COCHLEAR IMPLANT SYSTEM. THE PT'S DEVICE WAS EXPLANTED ON APPROX TWO MONTHS LATER, AND A NEW DEVICE WAS REIMPLANTED DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD. CI22N NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention