BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 4203119 · Received October 27, 2014

    Report

    Report Number
    6000034-2014-01512
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 13, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2014 TO REPOSITION A DISLODGED MAGNET. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682767 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM: PRODUCT CODE MCM COCHLEAR LTD. CI422

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Required Intervention