BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)

    MDR report key: 5665212 · Received May 18, 2016

    Report

    Report Number
    3007566237-2016-02044
    Event Type
    Injury
    Date Received
    May 18, 2016
    Date of Event
    July 1, 2004
    Report Date
    May 18, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NOTE THAT THIS REGULATORY REPORT INVOLVES TWO DIFFERENT PUBLICATIONS OF THE SAME LITERATURE ARTICLE, ONE WHICH WAS PUBLISHED TWO YEARS AFTER (2006) THE INITIAL 2004 PUBLICATION, AND WHICH HAD ADDITIONAL FOLLOW-UP INFORMATION, BUT INVOLVED THE SAME PATIENT COHORT, CONTAINED ALL THE ADVERSE EVENTS WHICH HAD OCCURRED AT THE TIME OF THE INITIAL 2004 PUBLICATION, AND WAS IN ALL OTHER WAYS THE SAME. MAIN COMPONENT OF THE SYSTEM INVOLVED IN THE REPORTED EVENT; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    STARR, P.A., TURNER, R.S., RAU, G., LINDSEY, N., HEATH, S., VOLZ, M., OSTREM, J.L., MARKS, W.J. MICROELECTRODE-GUIDED IMPLANTATION OF DEEP BRAIN STIMULATORS INTO THE GLOBUS PALLIDUS INTERNUS FOR DYSTONIA: TECHNIQUES, ELECTRODE LOCATIONS, AND OUTCOMES. NEUROSURG FOCUS. 2004. 17 (1):E4. SUMMARY: DEEP BRAIN STIMULATION (DBS) OF THE GLOBUS PALLIDUS INTERNUS (GPI) IS A PROMISING NEW PROCEDURE FOR THE TREATMENT OF DYSTONIA. THE AUTHORS PRESENT THEIR TECHNICAL APPROACH FOR PLACEMENT OF ELECTRODES INTO THE GPI IN AWAKE PATIENTS WITH DYSTONIA, INCLUDING THE METHODOLOGY USED FOR ELECTROPHYSIOLOGICAL MAPPING OF THE GPI IN THE DYSTONIC STATE, CLINICAL OUTCOMES AND COMPLICATIONS, AND THE LOCATION OF ELECTRODES ASSOCIATED WITH OPTIMAL BENEFIT. REPORTED EVENTS: CASE (B)(6): A (B)(6) MALE PATIENT WITH BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE GLOBUS PALLIDUS INTERNUS (GPI) FOR TARDIVE DYSTONIA EXPERIENCED A MULTIFOCAL LEFT FRONTAL HEMORRHAGE 2 DAYS POST-SURGERY, WITH THE APPEARANCE ON MRI IMAGING OF A VENOUS INFARCT RESULTING IN APHASIA AND CONTRALATERAL HEMIPARESIS. IT WAS NOTED THAT THE PATIENT RECOVERED FULLY BY 3 MONTHS POSTOPERATIVELY, BUT THEY DID NOT BENEFIT FROM THE DBS TREATMENT. THE PATIENT'S BURKE-FAHN-MARSDEN DYSTONIA RATING SCALE (BFMDRS) SCORE WAS 57 PRE-IMPLANT, COMPARED TO 53.5 AS OF 17 MONTHS POST-IMPLANT, AN IMPROVEMENT OF ONLY 6%. THE AUTHORS ADDED THAT DAMAGE TO THE DOMINANT SUPPLEMENTARY MOTOR AREA CAUSED BY VENOUS INFARCTION MAY HAVE BEEN A FACTOR THAT LIMITED EFFICACY. PATIENTS WITH LESS THAN 50% IMPROVEMENT WERE INCLUDED IN THE GROUP WITH ¿THE WORST CLINICAL OUTCOME¿ AND IT NOTED THAT IN THIS GROUP, WITH RESPECT TO MEASURES OF LEAD LOCATION WITH RESPECT TO THE BORDERS OF THE GPI IN THE PLANE OF THE COMMISSURES THE VARIANCE OF THE DISTRIBUTION OF LEAD LOCATIONS WAS SIGNIFICANTLY LARGER THAN IN THE GROUP WITH THE BEST CLINICAL OUTCOMES (>70% IMPROVEMENT). THE AUTHORS SUGGESTED THAT GREATER VARIABILITY IN ELECTRODE LOCATIONS MAY HAVE CONTRIBUTED TO A WORSENED CLINICAL OUTCOME IN SOME PATIENTS. ALL PATIENTS WERE IMPLANTED WITH MODEL 3387 LEADS AND EITHER MODEL 7426 OR 7428 NEUROSTIMULATORS. IT WAS NOT POSSIBLE TO ASCERTAIN ANY ADDITIONAL SPECIFIC DEVICE INFORMATION FROM THE ARTICLE, SUCH AS SERIAL NUMBERS, OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318449 IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other