BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 2931541 · Received January 28, 2013

    Report

    Report Number
    6000034-2013-00160
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 22, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT REPORTED "VIBRATIONS" AT THE IMPLANT SITE. REPROGRAMMING ATTEMPTS WERE MADE; WITHOUT SUCCESS. THE PATIENT UNDERWENT SURGERY TO REMOVE STAPES IN THE IMPLANTED EAR IN AN ATTEMPT TO ALLEVIATE THE SYMPTOMS. THE ISSUES REMAIN UNRESOLVED AND UNDER CLINICAL MANAGEMENT. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37064 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention