BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7422374 · Received April 11, 2018

    Report

    Report Number
    3007566237-2018-01056
    Event Type
    Malfunction
    Date Received
    April 11, 2018
    Date of Event
    January 13, 2018
    Report Date
    April 11, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED AGE REFLECTS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE LITERATURE ARTICLE. THE REPORTED SEX REFLECTS THAT OF THE MAJORITY OF THE PATIENTS REPORTED IN THE LITERATURE ARTICLE. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF ACCEPTANCE OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION; IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AKRAM, H., DAYAL, V., MAHLKNECHT, P., GEORGIEV, D., HYAM, J., FOLTYNIE, T., . . . ZRINZO, L. (2018). CONNECTIVITY DERIVED THALAMIC SEGMENTATION IN DEEP BRAIN STIMULATION FOR TREMOR. NEUROIMAGE: CLINICAL, 18, 130-142. DOI:10.1016/J.NICL.2018.01.008 SUMMARY: THE VENTRAL INTERMEDIATE NUCLEUS (VIM) OF THE THALAMUS IS AN ESTABLISHED SURGICAL TARGET FOR STEREOTACTIC ABLATION AND DEEP BRAIN STIMULATION (DBS) IN THE TREATMENT OF TREMOR IN PARKINSON'S DISEASE (PD) AND ESSENTIAL TREMOR (ET). IT IS CENTRALLY PLACED ON A CEREBELLO-THALAMO CORTICAL NETWORK CONNECTING THE PRIMARY MOTOR CORTEX, TO THE DENTATE NUCLEUS OF THE CONTRALATERAL CEREBELLUM THROUGH THE DENTATO-RUBRO-THALAMIC TRACT (DRT). THE VIM IS NOT READILY VISIBLE ON CONVENTIONAL MR IMAGING, SO IDENTIFYING THE SURGICAL TARGET TRADITIONALLY INVOLVED INDIRECT TARGETING THAT RELIES ON ATLAS-DEFINED COORDINATES. UNFORTUNATELY, THIS APPROACH DOES NOT FULLY ACCOUNT FOR INDIVIDUAL VARIABILITY AND REQUIRES SURGERY TO BE PERFORMED WITH THE PATIENT AWAKE TO ALLOW FOR INTRAOPERATIVE TARGETING CONFIRMATION. THE AIM OF THIS STUDY IS TO IDENTIFY THE VIM AND THE DRT USING PROBABILISTIC TRACTOGRAPHY IN PATIENTS THAT WILL UNDERGO THALAMIC DBS FOR TREMOR. FOUR MALE PATIENTS WITH TREMOR DOMINANT PD AND FIVE PATIENTS (THREE FEMALE) WITH ET UNDERWENT HIGH ANGULAR RESOLUTION DIFFUSION IMAGING (HARDI) (128 DIFFUSION DIRECTIONS, 1.5MM ISOTROPIC VOXELS AND B VALUE=1500) PREOPERATIVELY. PATIENTS RECEIVED VIM-DBS USING AN MR IMAGE GUIDED AND MR IMAGE VERIFIED APPROACH WITH INDIRECT TARGETING. POSTOPERATIVELY, USING PARALLEL GRAPHICAL PROCESSING UNIT (GPU) PROCESSING, THALAMIC AREAS WITH THE HIGHEST DIFFUSION CONNECTIVITY TO THE PRIMARY MOTOR AREA (M1), SUPPLEMENTARY MOTOR AREA (SMA), PRIMARY SENSORY AREA (S1) AND CONTRALATERAL DENTATE NUCLEUS WERE IDENTIFIED. ADDITIONALLY, VOLUME OF TISSUE ACTIVATION (VTA) CORRESPONDING TO ACTIVE DBS CONTACTS WERE MODELLED. RESPONSE TO TREATMENT WAS DEFINED AS 40% REDUCTION IN THE TOTAL FAHN-TOLOSA-MARTIN TREMOR RATING SCORE (FTMTRS) WITH DBS-ON, ONE YEAR FROM SURGERY. THREE OUT OF NINE PATIENTS HAD A SUBOPTIMAL, LONG-TERM RESPONSE TO TREATMENT. THE SEGMENTED THALAMIC AREAS CORRESPONDED WELL TO ANATOMICALLY KNOWN COUNTERPARTS IN THE VENTROLATERAL (VL) AND VENTROPOSTERIOR (VP) THALAMUS. THE DENTATE-THALAMIC AREA, LAY WITHIN THE M1-THALAMIC AREA IN A VENTRAL AND LATERAL LOCATION. STREAMLINES CORRESPONDING TO THE DRT CONNECTED M1 TO THE CONTRALATERAL DENTATE NUCLEUS VIA THE DENTATE-THALAMIC AREA, CLEARLY CROSSING THE MIDLINE IN THE MESENCEPHALON. GOOD RESPONSE WAS SEEN WHEN THE ACTIVE CONTACT VTA WAS IN THE THALAMIC AREA WITH HIGHEST CONNECTIVITY TO THE CONTRALATERAL DENTATE NUCLEUS. NON-RESPONDERS HAD ACTIVE CONTACT VTAS OUTSIDE THE DENTATE-THALAMIC AREA. WE CONCLUDE THAT PROBABILISTIC TRACTOGRAPHY TECHNIQUES CAN BE USED TO SEGMENT THE VL AND VP THALAMUS BASED ON CORTICAL AND CEREBELLAR CONNECTIVITY. THE THALAMIC AREA, BEST REPRESENTING THE VIM, IS CONNECTED TO THE CONTRALATERAL DENTATE CEREBELLAR NUCLEUS. CONNECTIVITY BASED SEGMENTATION OF THE VIM CAN BE ACHIEVED IN INDIVIDUAL PATIENTS IN A CLINICALLY FEASIBLE TIMESCALE, USING HARDI AND HIGH PERFORMANCE COMPUTING WITH PARALLEL GPU PROCESSING. THIS SAME TECHNIQUE CAN MAP OUT THE DRT TRACT WITH CLEAR MESENCEPHALIC CROSSING. REPORTED EVENTS: AN UNKNOWN AMOUNT OF PATIENTS HAD A POOR RESPONSE OR UNACCEPTABLE SIDE-EFFECTS DURING IMPLANT. IN THIS CASE, THE LEAD WAS REMOVED AND THE PROCESS WAS REPEATED FOLLOWING APPROPRIATE TARGETING ADJUSTMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263610 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 3389 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR