BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 5432278 · Received February 11, 2016

    Report

    Report Number
    6000034-2016-00277
    Event Type
    Malfunction
    Date Received
    February 11, 2016
    Date of Event
    January 15, 2016
    Report Date
    May 9, 2016
    Manufacturer
    COCHLEAR LTD .
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE COMMON DEVICE NAME IS MCM; NOT PGQ AS PREVIOUSLY REPORTED. THIS REPORT IS FILED JULY 01, 2016.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED, (B)(6) 2016. DEVICE IS CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT SUSTAINED A HEAD TRAUMA ON (B)(6) 2016. ON (B)(6) 2016 AN X-RAY WAS PERFORMED AND REVEALED THE IMPLANT MAGNET HAD BECOME DISLODGED. SUBSEQUENTLY ON (B)(6) 2016 THE DEVICE WAS EXPLANTED; DURING THE SAME SURGERY THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT, (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87993 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM, PRODUCT CODE: MCM COCHLEAR LTD . CI422

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention