BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2843254 · Received November 21, 2012

    Report

    Report Number
    6000034-2012-02233
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    March 28, 2012
    Report Date
    August 22, 2012
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    840024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FILED ON (B)(4), 2012.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6), 2012, FOR UNSPECIFIC MEDICAL REASONS. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    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 19 YR Required Intervention