BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1840055 · Received September 21, 2010

    Report

    Report Number
    6000034-2010-00619
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    September 17, 2010
    Report Date
    May 18, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED (B)(6), 2010, THE PATIENT WAS NOT REIMPLANTED. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED (B)(6), 2011.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT HAD NO AUDITORY RESPONSE TO STIMULATION RESULTING IN THE DECISION TO DISCONTINUE USE OF THE DEVICE. REPROGRAMMING ATTEMPTS WERE MADE, HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS. EXPLANT AND REIMPLANTATION IS PLANNED, BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE PT RECEIVED A SMALL BURN ON THEIR BACK. A PENCIL WAS IN USE AND HAD BEEN USED AT SOME TIME BEFORE DURING THE PROCEDURE AND THEN LAID ON THE DRAPES OVER THE PT'S BACK. THE DRAPES COVERING THE PT WERE MELTED AND THE PT'S BACK BENEATH WAS BURNED. NO ONE HAD ACTIVATED THE PENCIL AFTER ITS USE. THE SITE IS CONCERNED IF A SELF ACTIVATION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24R (CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention