BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2781688 · Received October 11, 2012

    Report

    Report Number
    6000034-2012-01961
    Event Type
    Injury
    Date Received
    October 11, 2012
    Date of Event
    August 20, 2012
    Report Date
    February 5, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    840024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT RETURNED TO MANUFACTURER DATE IS (B)(6) 2012; NOT (B)(6) 2012 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED (B)(4) 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED MIGRATION OF THE IMPLANT BODY RESULTING IN DISCOMFORT AND PAIN AROUND THE IMPLANT SIDE. THE DEVICE WAS EXPLANTED ON (B)(6) 2012. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, (B)(4) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI22M

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention