BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 5767767 · Received July 3, 2016

    Report

    Report Number
    6000034-2016-01394
    Event Type
    Injury
    Date Received
    July 3, 2016
    Date of Event
    August 2, 2016
    Report Date
    August 5, 2016
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED BY COCHLEAR LIMITED (MANUFACTURER) ON BEHALF OF COCHLEAR AMERICAS. THIS REPORT IS FILED ON JULY 04, 2016. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. H3 OTHER TEXT: IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED BY COCHLEAR LIMITED (MANUFACTURER) ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2016, AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY. DEVICE NOT YET RECEIVED BY MANUFACTURER.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED INTERMITTENCIES AND SUBSEQUENT LOSS OF CONNECTION TO THE INTERNAL DEVICE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS. IT IS UNKNOWN IF THERE ARE PLANS TO EXPLANT THE DEVICE AND REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, JULY 04, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421766 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI512 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention