BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 4654015 · Received April 2, 2015

    Report

    Report Number
    3007566237-2015-00855
    Event Type
    Injury
    Date Received
    April 2, 2015
    Date of Event
    March 3, 2015
    Report Date
    March 5, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT: PRODUCT ID 7428, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID 3387, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    BRUGGEMANN, N., KUHN, A., SCHNEIDER, S. A., KAMM, C., WOLTERS, A., KRAUSE, P., MORO, E., STEIGERWALD, F., WITTSTOCK, M., TRONNIER, V., LOZANO, A. M., HAMANI, C., POON, Y. Y., ZITTEL, S., WÄCHTER, T., DEUSCHL, G., KRÜGER, R., KUPSCH, A., MÜNCHAU, A., LOHMANN, K., VOLKMANN, J., KLEIN, C. SHORT- AND LONG-TERM OUTCOME OF CHRONIC PALLIDAL NEUROSTIMULATION IN MONOGENIC ISOLATED DYSTONIA. NEUROLOGY. 2015:PII 10. SUMMARY: DEEP BRAIN STIMULATION OF THE INTERNAL PALLIDUM (GPI-DBS) IS AN ESTABLISHED THERAPEUTIC OPTION IN TREATMENT-REFRACTORY DYSTONIA, AND THE IDENTIFICATION OF FACTORS PREDICTING SURGICAL OUTCOME IS NEEDED TO OPTIMIZE PATIENT SELECTION. IN THIS RETROSPECTIVE MULTICENTER STUDY, GPI-DBS OUTCOME OF 8 PATIENTS WITH DYT6, 9 WITH DYT1, AND 38 WITH ISOLATED DYSTONIA WITHOUT KNOWN MONOGENIC CAUSE (NON-DYT) WAS ASSESSED AT EARLY (1¿16 MONTHS) AND LATE (22¿92 MONTHS) FOLLOW-UP USING BURKE-FAHN-MARSDEN DYSTONIA RATING SCALE (BFMDRS) SCORES. AT EARLY FOLLOW-UP, MEAN REDUCTION OF DYSTONIA SEVERITY WAS GREATER IN PATIENTS WITH DYT1 (BFMDRS SCORE: 260%) AND NON-DYT DYSTONIA (252%) THAN IN PATIENTS WITH DYT6 DYSTONIA (232%; P 5 0.046). ACCORDINGLY, THE RATE OF RESPONDERS WAS CONSIDERABLY LOWER IN THE LATTER GROUP (57% VS .90%; P 5 0.017). AT LATE FOLLOW-UP, HOWEVER, GPI-DBS RESULTED IN COMPARABLE IMPROVEMENT IN ALL 3 GROUPS (DYT6, 242%; DYT1, 244; NON-DYT, 261%). ADDITIONAL DBS OF THE SAME OR ANOTHER BRAIN TARGET WAS PERFORMED IN 3 OF 8 PATIENTS WITH DYT6 DYSTONIA WITH VARYING RESULTS. REGARDLESS OF THE GENOTYPE, PATIENTS WITH A SHORTER DURATION FROM ONSET OF DYSTONIA TO SURGERY HAD BETTER CONTROL OF DYSTONIA POSTOPERATIVELY. LONG-TERM GPI-DBS IS EFFECTIVE IN PATIENTS WITH DYT6, DYT1, AND NON-DYT DYSTONIA. HOWEVER, THE EFFECT OF DBS APPEARS TO BE LESS PREDICTABLE IN PATIENTS WITH DYT6, SUGGESTING THAT PRE-DBS GENETIC TESTING AND COUNSELING FOR KNOWN DYSTONIA GENE MUTATIONS MAY BE INDICATED. GPI-DBS SHOULD PROBABLY BE CONSIDERED EARLIER IN THE DISEASE COURSE. THIS STUDY PROVIDES CLASS IV EVIDENCE THAT LONG-TERMGPI-DBS IMPROVES DYSTONIA IN PATIENTS WITH DYT1, DYT6, AND NON-DYT DYSTONIA. REPORTED EVENT: ONE (B)(6) FEMALE PATIENT UNDERWENT BILATERAL GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) IMPLANT FOR DYSTONIA. BECAUSE THERE WAS NO IMPROVEMENT IN CERVICAL AND TRUNCAL DYSTONIA, A SECOND PAIR OF DBS ELECTRODES WAS IMPLANTED INTO THE POSTERIOR PORTIONS OF EACH GPI ONE YEAR LATER, BUT AGAIN WITHOUT BENEFIT ON THE AXIAL DYSTONIA. FOUR YEARS LATER, SHE ADDITIONALLY RECEIVED BILATERAL SUBTHALAMIC NUCLEUS (STN) DBS BECAUSE OF A PERSISTENT DBS FAILURE. SHORTLY THEREAFTER, ALL GPI AND STN DBS HARDWARE WERE REMOVED BECAUSE OF INFECTION. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: KINETRA INS MODEL 7428 AND LEAD MODEL 3387 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
    217054 KINETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION 7428 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention