BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 5832226 · Received July 28, 2016

    Report

    Report Number
    6000034-2016-01578
    Event Type
    Malfunction
    Date Received
    July 28, 2016
    Date of Event
    July 20, 2016
    Report Date
    August 10, 2016
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. THIS REPORT IS FILED AUGUST 16, 2016. (B)(4).

    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 ON JULY 29, 2016. H3 OTHER TEXT: DEVICE NOT RETURNED TO 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 DEVICE WAS EXPLANTED ON (B)(6) 2016 AND THE PATIENT WAS IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481761 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI512 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention