BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2527862 · Received April 11, 2012

    Report

    Report Number
    3007566237-2012-00729
    Event Type
    Malfunction
    Date Received
    April 11, 2012
    Report Date
    April 5, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: CHANG, W.S., KIM, H.Y., KIM, J.P., PARK, Y.S., CHUNG, S.S., CHANG, J.W., BILATERAL SUBTHALAMIC DEEP BRAIN STIMULATION USING SINGLE TRACK MICROELECTRODE RECORDING, ACTA NEUROCHIRURGICA, VOLUME 153 (2011). DOI 10.1007/S00701-011-0953-1. SUMMARY: MICROELECTRODE RECORDING (MER) IS WIDELY USED DURING DEEP BRAIN STIMULATION (DBS) PROCEDURES BECAUSE MER CAN IDENTIFY STRUCTURAL BORDERS AND ELOQUENT STRUCTURES, LOCALIZE SOMATOTOPIC ARRANGEMENTS, AND PROVIDE AN OUTLINE OF THE THREE-DIMENSIONAL SHAPES OF TARGET NUCLEI. HOWEVER, MER MAY CAUSE INTRACRANIAL HEMORRHAGE. WE PREFORMED SINGLE TRACK MER DURING DBS PROCEDURES, ANALYZED THE ACCURACY OF ELECTRODE POSITIONING WITH MRI, AND COMPARED THE AMOUNT OF AIR AND THE POTENTIAL RISK OF INTRACRANIAL HEMORRHAGE. A TOTAL OF 46 ELECTRODES WERE PLACED IN 23 PATIENTS WHO SUFFERED FROM ADVANCED PARKINSON'S DISEASE AND WHO UNDERWENT BILATERAL SUBTHALAMIC NUCLEUS DBS USING SINGLE TRACK MER. THE ACCURACY OF ELECTRODE POSITIONING APPEARS TO BE ACCEPTABLE UNDER SINGLE TRACK MER DURING STN DBS WITH CAREFUL ELECTROPHYSIOLOGICAL AND NEUROLOGICAL MONITORING. THE RISK OF INTRACRANIAL HEMORRHAGE APPEARS TO BE MINIMAL, ESPECIALLY IN ELDERLY PATIENTS WITH ATROPHIC BRAINS. REPORTED EVENTS: POSTOPERATIVE MRI OF A (B)(6) FEMALE PATIENT IN OUR SERIES REVEALED A LARGE AMOUNT OF AIR IN THE LEFT FRONTAL AREA, AND THE ACTUAL ERROR IN THE PLACEMENT OF THE LEFT ELECTRODE IN THIS PATIENT WAS 35 MM, A VERY SERIOUS ERROR THAT COULD CAUSE ELECTRODE MALFUNCTION. REPOSITIONING RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 3387

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR