BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 5743779 · Received June 22, 2016

    Report

    Report Number
    6000034-2016-01237
    Event Type
    Injury
    Date Received
    June 22, 2016
    Date of Event
    June 17, 2016
    Report Date
    June 21, 2016
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED BY COCHLEAR LIMITED (MANUFACTURER) ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. CORRECTION: THE REVISION SURGERY PERFORMED ON (B)(6) 2016 WAS TO REMOVE THE MAGNET; NOT REPOSITION THE MAGNET AS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED BY COCHLEAR LIMITED ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818. EXEMPTION NUMBER E2016011. H3 OTHER TEXT : IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED A MAGNET DISLODGEMENT DURING AN MRI (TESLA STRENGTH AND DATE NOT REPORTED). THE PATIENT'S HEAD WAS NOT WRAPPED PER THE MANUFACTUER'S INSTRUCTIONS FOR USE OF MRI. SURGERY TO REPOSITION THE MAGNET WAS COMPLETED ON JUNE 17, 2016. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396622 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI512 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention