BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DBS LEAD

    MDR report key: 5344442 · Received January 5, 2016

    Report

    Report Number
    3007566237-2016-00026
    Event Type
    Injury
    Date Received
    January 5, 2016
    Date of Event
    December 10, 2015
    Report Date
    December 12, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ABSTRACT OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE PRESENTER OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. (B)(4).

    Description of Event or Problem · 1

    MANDYBUR, G., BIDDELL, K.M., DUKER, A.P. CAN MICROELECTRODE RECORDING BE USED TO ACCURATELY DIFFERENTIATE THE RED NUCLEUS FROM SUBTHALAMIC NUCLEUS? (10761). NORTH AMERICAN NEUROMODULATION SOCIETY 19TH ANNUAL MEETING. 2015. 48. SUMMARY: MICROELECTRODE RECORDING (MER) IS A MAINSTAY OF MODERN DEEP BRAIN STIMULATION (DBS) SURGERY. HOWEVER, THE NECESSITY OF THIS TECHNIQUE HAS BEEN A SUBJECT OF DEBATE, AND CONTROVERSY EXISTS AS TO WHETHER ITS BENEFITS EXCEED THE POTENTIAL INCREASED COMPLICATION RISK IT MAY ADD TO THE DBS PROCEDURE. ONE ARGUMENT FOR THE USE OF MER IS ITS ABILITY TO DISTINGUISH BETWEEN THE SUBTHALAMIC NUCLEUS (STN) AND OTHER NEARBY STRUCTURES. THE RED NUCLEUS IS ONE SUCH STRUCTURE WHICH IN TWO OTHER PUBLISHED INSTANCES HAS BEEN FOUND TO HAVE SIMILAR MER CHARACTERISTICS TO THE STN. WE PRESENT A CASE REPORT OF THE MISIDENTIFICATION OF THE RED NUCLEUS AS STN BASED ON MER CHARACTERISTICS. EVENTS: ONE (B)(6)-YEAR-OLD FEMALE PATIENT WITH A SIX YEAR HISTORY OF PARKINSON'S DISEASE UNDERWENT SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS). DURING THE PROCEDURE, MICROELECTRODE RECORDING (MER) VISUAL AND AUDITORY ANALYSIS SUGGESTED THAT THE RECORDING ELECTRODE WAS IN THE STN, HOWEVER, MACROSTIMULATION OF THE DBS LEAD CAUSED SIDE EFFECTS OF DIPLOPIA AND OCULAR DYSMOTILITY SUGGESTING MEDIAL DISPLACEMENT OF THE TARGET. NEW MER TRACTS WERE PERFORMED AND PROPER STN RECORDINGS WERE THEN FOUND 4MM LATERAL TO THE INITIAL PLACEMENT. LATER POSTOPERATIVE IMAGING CLEARLY SHOWED A TRACT VOID IN THE RED NUCLEUS. POST-OPERATIVE 6 MONTH FOLLOW-UP SHOWED A 27% IMPROVEMENT IN UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS) MOTOR SCORES. RETROSPECTIVE ROOT MEAN SQUARE (RMS) AND POWER SPECTRAL DENSITY (PSD) ANALYSIS WERE NOT ABLE TO DISTINGUISH THE RED NUCLEUS RECORDINGS FROM THE STN RECORDINGS, THUS ALSO REVEALING THEIR DEFICIENCY. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5269 UNKNOWN DBS LEAD STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention