BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1020954 · Received March 28, 2008

    Report

    Report Number
    6000034-2008-00148
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 27, 2008
    Report Date
    October 16, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PATIENT REPORTED POOR PERFORMANCE AND LACK OF BENEFIT FROM THE AUDITORY BRAINSTEM IMPLANT SYSTEM. THE PATIENT'S DEVICE WAS EXPLANTED 2008 AND A NEW DEVICE WAS REIMPLANTED DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM COCHLEAR LTD. ABI24M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male Required Intervention