BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 2930618 · Received January 28, 2013

    Report

    Report Number
    6000034-2013-00154
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    890027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IMPLANTED DEVICE REMAINS..

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA ON (B)(6) 2012, IN ORDER TO FACILITATE INTEGRITY TESTING AND CT SCAN. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37065 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD CI22M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention