BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 2900540 · Received January 7, 2013

    Report

    Report Number
    6000034-2013-00047
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    November 27, 2012
    Report Date
    December 12, 2012
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED DIZZINESS AND A LACK OF AUDITORY BENEFIT WITH STIMULATION, AND THE ISSUE COULD NOT BE RESOLVED. A CT SCAN (DATE NOT REPORTED) INDICATED EXTRACOCHLEAR ELECTRODE ARRAY PLACEMENT. THE DEVICE WAS EXPLANTED (B)(6) 2012, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7396 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention