BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7318600 · Received March 6, 2018

    Report

    Report Number
    3007566237-2018-00667
    Event Type
    Malfunction
    Date Received
    March 6, 2018
    Date of Event
    July 14, 2017
    Report Date
    March 6, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_STIMLOC_ACC, PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. KLOC, M., KOSUTZKA, Z., STENO, J., VALKOVIC, P. PREVALENT PLACEMENT ERROR OF DEEP BRAIN STIMULATION ELECTRODE IN MOVEMENT DISORDERS (TECHNICAL CONSIDERATIONS). BRATISL LEK LISTY. 2017;118(11):647-653. DOI: 10.4149/BLL_2017_123 . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: BACKGROUND: DEEP BRAIN STIMULATION IS AN EFFECTIVE AND SAFE TECHNIQUE. DISPLACEMENT OF THE ELECTRODE RELATIVE TO THE OPTIMAL STIMULATION SITE CAN LEAD TO INSUFFICIENT EFFECT AND SOMETIMES TO THE NEED OF OPERATIVE ELECTRODE RE-POSITION. OBJECTIVE: THIS STUDY WAS AIMED TO ANALYSE TARGETING ACCURACY OF DEEP BRAIN STIMULATION ELECTRODE IMPLANTATION TO SUBTHALAMIC NUCLEUS (STN) AND GLOBUS PALLIDUS INTERNUS (GPI). IT DETECTED POSSIBLE CAUSES OF INACCURACY AND PREVALENT SHIFT TO CERTAIN DIRECTION. METHODS: TARGETING ACCURACY WAS ANALYSED IN 47 PATIENTS WITH PARKINSON´S DISEASE (PD) AND 11 PATIENTS WITH DYSTONIA WITH BILATERAL IMPLANTATION OF DEEP BRAIN STIMULATION ELECTRODES BETWEEN YEARS 2009 AND 2016. RESULTS: A SHIFT OF ELECTRODE TO PREVALENT DIRECTION WAS OBSERVED ON THE LEFT SIDE TO MEDIAL AND POSTERIOR AND ON THE RIGHT SIDE TO LATERAL DIRECTION. GREATER SHIFT WAS OBSERVED ON THE LEFT SIDE AND IN A HIGHER ANGULATION OF TRAJECTORY LATERALLY. MOVEMENT OF THE ELECTRODE, BECAUSE OF ITS TRACTION IN ANCHORING DEVICE, WAS IDENTIFIED AS A POSSIBLE FACTOR FOR PREVALENT ELECTRODE SHIFT. CALIBRATION OF STEREOTACTIC COORDINATES TO CORRECT PREVALENT SHIFT WAS USED. CONCLUSION: TARGETING INACCURACY IS THE RESULT OF ACCUMULATION OF ERRORS IN INDIVIDUAL STEPS OF ELECTRODE IMPLANTATION. DIRECTION OF THE SHIFT CAN BE RANDOM OR IT CAN BE TOWARD A PREVALENT DIRECTION. A CORRECTION OF PREVALENT ERROR CAN PREVENT A SUBOPTIMAL ELECTRODE PLACEMENT. REPORTED EVENTS: 1. 8 PATIENTS WITH EITHER STN-DBS FOR PD EXPERIENCED A LEFT SHIFT OF THEIR ELECTRODE IN THE PLANE OF THE STIMLOC IN A MEDIAL DIRECTION TOWARDS THE CENTER OF THE BURR HOLE. THE AVERAGE ERROR FROM THE INTENDED TARGET IN THE X-AXIS WAS 1.875 MM, AND AN UNKNOWN ERROR IN THE Y-DIRECTION. THE MAXIMUM OBSERVED ERROR IN THE X-AXIS IN THIS GROUP WAS 2.4 MM AND 5 PATIENTS HAD =2 MM. ALL OF THESE PATIENTS ALSO REPORTEDLY HAD BETWEEN 0.4 AND 1.5 MM OF ELECTRODE BENDING AND A SHIFT OF THE LEAD IN THE STIMLOC DEVICE. NOTABLY, THE AUTHORS ONLY DESCRIBED ERRORS OF GREATER THAN 2 MM AS ¿POTENTIALLY IMPORTANT,¿ AND ADDED THAT THERE WERE SEVERAL PATIENTS WITH ERRORS CLOSE 2 MM WITH PNEUMOCEPHALUS ON POSTOPERATIVE CT. 2. 6 PATIENTS WITH EITHER STN-DBS FOR PD EXPERIENCED A LEFT ELECTRODE SHIFT OF LESS THAN A 0.9 MM IN THE X-AXIS IN THE PLANE OF THE STIMLOC. THE AVERAGE ERROR FROM THE INTENDED TARGET IN THE X-AXIS WAS 0.45 MM AND AN UNKNOWN ERROR IN THE Y-DIRECTION. ALL OF THESE PATIENTS ALSO REPORTEDLY HAD BETWEEN 0.5 AND 1.3 MM OF ELECTRODE BENDING. NOTABLY, THE AUTHORS ONLY DESCRIBED ERRORS OF GREATER THAN 2 MM AS ¿POTENTIALLY IMPORTANT.¿ THE 3. 3 PATIENTS WITH EITHER STN-DBS FOR PD EXPERIENCED A LEFT ELECTRODE SHIFT OF BETWEEN 0.1-1.4 MM IN THE X-AXIS AND AN UNKNOWN SHIFT IN THE Y-AXIS, WITH THE DEFINITIVE ELECTRODE CLOSE TO THE MARGINS OF THE BURR HOLE. THE AUTHORS REPORTED AN AVERAGE VECTOR ERROR IN THE Y-AXIS OF THE LEFT LEAD OF 0.24 MM. NOTABLY, THE AUTHORS ONLY DESCRIBED ERRORS OF GREATER THAN 2 MM AS ¿POTENTIALLY IMPORTANT.¿ 4. AN UNCLEAR NUMBER OF PATIENTS WITH EITHER STN-DBS FOR PD EXPERIENCED A SHIFT OF THE RIGHT ELECTRODE LATERAL TO THE PLANNED TRAJECTORY AND BENDING OF THE ELECTRODE WITH ¿MEDIAL CONVEXITY.¿ THE AUTHORS REPORTED AN AVERAGE VECTOR ERROR IN THE X-AXIS OF 0.55 MM AND 0.24 MM IN THE Y-DIRECTION. NOTABLY, THE AUTHORS ONLY DESCRIBED ERRORS OF GREATER THAN 2 MM AS ¿POTENTIALLY IMPORTANT.¿ IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159734 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1