BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 2160341 · Received July 13, 2011

    Report

    Report Number
    6000034-2011-00464
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    April 19, 2011
    Report Date
    May 24, 2011
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2011 TO DRAIN THE IMPLANT SITE OF AN AIR POCKET. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM MCM COCHLEAR LTD CI512 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention