BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3200177 · Received July 1, 2013

    Report

    Report Number
    6000034-2013-01187
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    July 8, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED OCTOBER 16, 2013.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED (DATE NOT REPORTED) FOR REASONS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(4). IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300457 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention