BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMINANT LOCALIZER

    MDR report key: 2770166 · Received October 1, 2012

    Report

    Report Number
    1222895-2012-00030
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    August 9, 2012
    Report Date
    October 1, 2012
    Manufacturer
    INTEGRA BURLINGTON, MA, INC
    Product Code
    HAW
    PMA / PMN Number
    K946252
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    "THE PLATE ON THE RIGHT SIDE IS OFF OF THE LUMINANT LOCALIZER. THE STAFF HAD TO REMOVE THE SKULL PIN FROM PT'S HEAD TO CHANGE INTO (B)(4) PRODUCT. MEANWHILE IT MAKES THE TWICE INJURIES ON PTS. THIS PROBLEM IS VERY SERIOUS AND WILL MAKE AN ADVERSE INFLUENCE FOR COMING ACTIVITIES." THE PT RECEIVED A LOCAL ANESTHESIA FOR LESIONING BY USING A RADIOFREQUENCY ELECTRODE FOR A MENTAL DISORDER. THERE WAS NO DELAY IN THE PROCEDURE AS THEY HAD THE LEKSELL AS A BACK UP. THE PT DID NOT INCUR AN INJURY, HOWEVER, HE HAD TO HAVE A DOUBLE HEADRING INSTALLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMINANT LOCALIZER NA HAW INTEGRA BURLINGTON, MA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR