BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3833761 · Received May 27, 2014

    Report

    Report Number
    6000034-2014-00748
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 12, 2014
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED (B)(6) 2014 DUE TO LACK OF BENEFIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310125 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD . CI512

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention