BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2932548 · Received January 29, 2013

    Report

    Report Number
    6000034-2013-00175
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 30, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT REVISION SURGERY TO REPLACE THE MAGNET HAS BEEN COMPLETED ON (B)(6), 2013. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF CONNECTION TO THE INTERNAL DEVICE SUBSEQUENT TO SUSTAINING A HEAD TRAUMA RESULTING IN THE DISLODGMENT OF THE EXTERNAL MAGNET. REVISION SURGERY TO EXCHANGE THE MAGNET IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT, (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39174 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention