BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3031693 · Received April 2, 2013

    Report

    Report Number
    6000034-2013-00589
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 21, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2013, TO REPOSITION THE MAGNET. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA. THIS REPORT IS FILED (B)(4) 2013. IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT AN MRI SCAN IN (B)(6) 2013, WITHOUT PREVIOUSLY REMOVING THE INTERNAL MAGNET OF THE RECEIVER/STIMULATOR. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AROUND THE IMPLANT SITE. THE IMPLANTED DEVICE REMAINS. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013, TO REPOSITION THE INTERNAL MAGNET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135322 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI512

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention