BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 2914724 · Received January 14, 2013

    Report

    Report Number
    6000034-2013-00088
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    November 8, 2012
    Report Date
    January 8, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED LOSS OF AUDITORY BENEFIT WITH DEVICE USE, RESULTING IN THE DECISION TO EXPLANT THE DEVICE ON (B)(6) 2012. DURING THE SAME SURGERY, THE PATIENT WAS REIMPLANTED WITH AN AUDITORY BRAINSTEM IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20130 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD. CI512

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention