BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 5874869 · Received August 15, 2016

    Report

    Report Number
    6000034-2016-01579
    Event Type
    Malfunction
    Date Received
    August 15, 2016
    Date of Event
    June 27, 2016
    Report Date
    August 16, 2016
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    P970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON AUGUST 15, 2016, BY COCHLEAR LIMITED ON BEHALF OF COCHLEAR AMERICAS. REGISTRATION NUMBER 3009092818. 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 (DATE NOT REPORTED) AND THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE DURING THE SAME SURGERY. THIS REPORT IS FILED AUGUST 22, 2016. H3 OTHER TEXT : 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. REPROGRAMMING ATTEMPTS WERE MADE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS. EXPLANTATION OF THE DEVICE IS PLANNED; HOWEVER, IT IS UNKNOWN WHETHER THIS HAS YET TO OCCUR AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528080 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CI512 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention