BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1081708 · Received July 25, 2008

    Report

    Report Number
    6000034-2008-00410
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    May 27, 2008
    Report Date
    June 24, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    THE DEVICE WAS RECEIVED WITH PAPERWORK INDICATING "NO AUDITORY REACTION". NO INFO HAD BEEN RECEIVED PRIOR TO THE PT'S EXPLANTATION IN 2008. NO REIMPLANTATION PLANS WERE REPORTED AT THE TIME OF THIS REPORT WAS FILED, 07/24/08.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention