BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 12461049 · Received September 13, 2021

    Report

    Report Number
    2182207-2021-01561
    Event Type
    Injury
    Date Received
    September 13, 2021
    Date of Event
    May 31, 2021
    Report Date
    September 13, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ROH H, KIM JH, KOH SB, KIM JH. CORRELATING BETA OSCILLATIONS FROM INTRAOPERATIVE MICROELECTRODE AND POSTOPERATIVE IMPLANTED ELECTRODE IN PATIENTS UNDERGOING SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION FOR PARKINSON DISEASE; A FEASIBILITY STUDY. WORLD NEUROSURG. 2021; 152. 10.1016/J.WNEU.2021.05.136. PT AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. GENDER: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389, SERIAL/LOT #: UNKNOWN, UDI#: (B)(4).

    Description of Event or Problem · 1

    SUMMARY: THE AUTHORS SOUGHT TO INVESTIGATE THE FEASIBILITY OF INTRAOPERATIVE LOCAL FIELD POTENTIAL (LFP) RECORDING FROM THE MICRO ELECTRODE DURING DEEP BRAIN STIMULATION SURGERY FOR PATIENTS WITH PARKINSON DISEASE. SIXTEEN SUBTHALAMIC NUCLEUS RECORDINGS FROM 10 PARKINSON DISEASE PATIENTS WHO UNDERWENT DEEP BRAIN STIMULATION SURGERY WERE INCLUDED IN THIS STUDY. SIGNALS FROM MICROELECTRODES WERE AMPLIFIED AND DIFFERENTLY FILTERED TO DISPLAY REAL-TIME SINGLE-UNIT NEURONAL ACTIVITY AND LFP SIMULTANEOUSLY DURING SURGERY. LFP RECORDINGS WERE ALSO RECORDED POSTOPERATIVELY FROM THE IMPLANTED MACROELECTRODES AND, POWER SPECTRAL DENSITY AND PEAK FREQUENCY OF BETA OSCILLATION OF LFP (BETA LFP) BETWEEN 2 CONDITIONS WERE COMPARED. STABLE INTRAOPERATIVE BETA LFP WERE OBSERVED IN 68.75% (11 OF 16) CASES. THERE WAS NO SIGNIFICANT DIFFERENCE OF PEAK FREQUENCY BETWEEN INTRAOPERATIVE AND POSTOPERATIVE BETA-LFP BUT SIGNIFICANT DIFFERENCE OF MEAN PERCENTAGE OF BETA LFP WAS NOTED BETWEEN 2 CONDITIONS. DESPITE LOW SIGNAL-TO-NOISE RATIO AND SUSCEPTIBILITY TO NOISES FROM EXTERNAL SOURCES, THIS STUDY SHOWS THAT INTRAOPERATIVE RECORDING OF BETA LFP USING MICROELECTRODE IS FEASIBLE. AND, GIVEN THAT NO SIGNIFICANT DIFFERENCE IN PEAK FREQUENCY OF BETA LFP BETWEEN INTRAOPERATIVE AND POSTOPERATIVE LFP WAS FOUND, WE SUGGEST THAT NOT ONLY INTRAOPERATIVE BETA LFP CAN BE USED AS A RELIABLE SURROGATE FOR POSTOPERATIVE BETA LFP, BUT IT CAN ALSO PROVIDE US AN INFORMATION FOR ESTIMATING THE LOCATION WITH MAXIMAL POWER OF BETA OSCILLATION WITHIN THE SUBTHALAMIC NUCLEUS. REPORTED EVENT: A PATIENT IMPLANTED WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSONS DISEASE (PD) UNDERWENT REVISION DUE TO MISPLACED LEAD. LEAD MISPLACEMENT WAS IDENTIFIED VIA POSTOPERATIVE IMAGING. THE PATIENT EXPERIENCED SIGNIFICANT SIDE EFFECTS AS A RESULT OF MISPLACEMENT. THE MISPLACEMENT WAS DUE TO A BENT GUIDANCE TUBE. THE FOLLOWING DEVICE INFORMATION WAS IDENTIFIED FROM THE ARTICLE: LEAD MODEL 3389.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359470 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention