BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24

    MDR report key: 6371047 · Received March 1, 2017

    Report

    Report Number
    6000034-2017-00460
    Event Type
    Injury
    Date Received
    March 1, 2017
    Report Date
    February 23, 2017
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MARCH 02, 2017. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT'S DEVICE HAS REPORTEDLY BEEN EXPLANTED (DATE NOT REPORTED) DUE TO AN EXTRUSION. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150388 NUCLEUS 24 NUCLEUS 24 COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD CI24M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention