BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1202703 · Received October 16, 2008

    Report

    Report Number
    6000034-2008-00587
    Event Type
    Injury
    Date Received
    October 16, 2008
    Date of Event
    August 27, 2008
    Report Date
    September 23, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PT'S RECEIVER/STIMULATOR MIGRATED AND THE SKIN COVERING THE DEVICE WAS "EXTREMELY" THIN. A CT SCAN WAS RECOMMENDED BY THE SURGEON. IN 2008, THE PT UNDERWENT A REVISION SURGERY TO REPOSITION AND STABILIZE THE RECEIVER/STIMULATOR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention