BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3033603 · Received April 3, 2013

    Report

    Report Number
    6000034-2013-00616
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 21, 2013
    Report Date
    December 3, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2013; DURING THE SAME SURGERY THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: THE 'TYPE OF REPORTABLE EVENT' IS SERIOUS INJURY; NOT MALFUNCTION AS PREVIOUSLY REPORTED. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. THIS REPORT IS FILED APRIL 2, 2014.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED FACIAL NERVE STIMULATION. REPROGRAMMING ATTEMPTS WERE MADE WHICH INITIALLY ALLEVIATED THE PROBLEM; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE PATIENT HAS STOPPED USING THE DEVICE. EXPLANT AND REIMPLANTATION IS PLANNED BUT HAS NOT TAKEN PLACE AT THE TIME OF THIS REPORT (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136198 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI512 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention