BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3970835 · Received July 31, 2014

    Report

    Report Number
    6000034-2014-01058
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 10, 2014
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT NEVER EXPERIENCED AUDITORY PERCEPTIONS FROM THE INTERNAL DEVICE AND THE DEVICE WAS EXPLANTED (DATE NOT REPORTED). THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447086 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD . CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention