BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 5855443 · Received August 8, 2016

    Report

    Report Number
    6000034-2016-01527
    Event Type
    Injury
    Date Received
    August 8, 2016
    Report Date
    August 24, 2016
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON AUGUST 9, 2016, BY COCHLEAR LIMITED ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818. EXEMPTION NUMBER E2016011. H3 OTHER TEXT : DEVICE NOT RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED BY COCHLEAR LIMITED (MANUFACTURER) ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. THIS REPORT IS FILED AUGUST 30, 2016. (B)(4).

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED A BREAKDOWN OF THE SKINFLAP, RESULTING IN INFECTED FLAP TISSUE AND EXTRUSION OF THE RECEIVER STIMULATOR. ADDITIONALLY, THE ELECTRODE ARRAY MIGRATED INTO THE MASTOID CAVITY. SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2016. IT IS UNKNOWN WHETHER THE PATIENT WAS REIMPLANTED WITH ANOTHER DEVICE, AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506071 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI512 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention