BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1823036 · Received September 1, 2010

    Report

    Report Number
    6000034-2010-00584
    Event Type
    Injury
    Date Received
    September 1, 2010
    Date of Event
    July 22, 2010
    Report Date
    December 12, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PATIENT EXPERIENCED NO AUDITORY PERCEPTS AT INITIAL ACTIVATION. PROGRAMMING ADJUSTMENTS WERE MADE BUT WERE UNSUCCESSFUL AT RESOLVING THE PROBLEM. THE DEVICE WAS EXPLANTED ON (B)(6), 2010 AND THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE DURING THE SAME SURGERY. AT INITIAL ACTIVATION ON (B)(6), 2010, THE PATIENT EXPERIENCED AN AUDITORY RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI512 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention