BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3022288 · Received March 27, 2013

    Report

    Report Number
    6000034-2013-00553
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 11, 2013
    Report Date
    April 27, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013 TO RE-ADJUST THE IMPLANT BODY. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED AN EXTRUSION OF THE IMPLANT BODY.A REVISION SURGERY IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT, (B)(6), 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126481 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention