BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 4841337 · Received June 12, 2015

    Report

    Report Number
    6000034-2015-00912
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    May 14, 2015
    Report Date
    August 27, 2015
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED OCTOBER 21, 2015.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED NO SOUND FROM THE DEVICE AT INITIAL ACTIVATION. A CT SCAN PERFORMED (DATE NOT REPORTED) REVEALED THE ARRAY TO BE EXTRA COCHLEA. SUBSEQUENTLY THE DEVICE WAS EXPLANTED ON (B)(6) 2015; DURING THE SAME PROCEDURE, THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384440 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM COCHLEAR LTD . CI512

    Patients

    Seq Age Sex Outcome Treatment
    1 34 MO Required Intervention