BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    64 CONTACT PLATINUM CONFORMAL 4 SEP LEADS

    MDR report key: 1202190 · Received October 16, 2008

    Report

    Report Number
    9612007-2008-00029
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 22, 2008
    Report Date
    October 15, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES IMPLANTS S.A.
    Product Code
    GZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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 UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT FIVE DAYS AFTER THE GRID WAS PLACED, SOME ELECTRODES CEASED TO FUNCTION, GRADUALLY PROGRESSING SO THAT ALL ELECTRODES ON THE LAST TAIL OF THE DEVICE CEASED TO FUNCTION. THE SURGEON WAS UNABLE TO PERFORM GRID STIMULATION ON THIS AREA. AT THE USER FACILITY, ALL CABLES WERE CHECKED AND SOME CABLES WERE REPLACED, HOWEVER, THERE WAS STILL NO DATA OBTAINED FROM THESE CONTACTS. IN RESPONSE TO AN EMAIL REQUESTING MORE INFO, THE REPORTER STATED THAT THERE WAS NO ADVERSE EVENT RELATED TO THE MALFUNCTION. THE LOSS OF ELECTRODES OCCURRED AFTER THE CAPTURE OF SEIZURE ACTIVITY, AND THE SEIZURE FOCUS WAS NOT IN THE ELECTRODES THAT WERE LOST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 64 CONTACT PLATINUM CONFORMAL 4 SEP LEADS EPILEPSY GRID ELECTRODES GZL INTEGRA NEUROSCIENCES IMPLANTS S.A. 0149234

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR