BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2882851 · Received December 21, 2012

    Report

    Report Number
    6000034-2012-02436
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 30, 2012
    Report Date
    June 3, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    840024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: PMA NUMBER IS (B)(4) NOT (B)(4) AS PREVIOUSLY REPORTED. THIS REPORT IS FILED (B)(4) 2013.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PER THE CLINIC, THE EXPERIENCED HEAD TRAUMA RESULTING IN THE MIGRATION OF THE IMPLANT BODY. THE DEVICE WAS EXPLANTED ON (B)(6) 2012, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THE MANUFACTURER BECAME AWARE UPON RECEIPT OF THE EXPLANTED DEVICE ON (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 43 YR Required Intervention