BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 6694449 · Received July 7, 2017

    Report

    Report Number
    3007566237-2017-02720
    Event Type
    Injury
    Date Received
    July 7, 2017
    Date of Event
    May 2, 2017
    Report Date
    July 7, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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 THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. INFORMATION REFERENCES THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3389, PRODUCT TYPE LEAD. PRODUCT ID NEU_UNKNOWN_EXT, PRODUCT TYPE EXTENSION.

    Description of Event or Problem · 1

    RASOULI, J., RAMDHANI, R., PANOV, FE., DIMOV, A., ZHANG, Y., CHO, C., WANG, Y., KOPELL, BH. UTILIZATION OF QUANTITATIVE SUSCEPTIBILITY MAPPING FOR DIRECT TARGETING OF THE SUBTHALAMIC NUCLEUS DURING DEEP BRAIN STIMULATION SURGERY. OPER NEUROSURG ((B)(6)). 2017. DOI: 10.1093/ONS/OPX131 SUMMARY: DEEP BRAIN STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN) HAS DEMONSTRATED EFFICACY IN IMPROVING MOTOR DISABILITY IN PARKINSON'S DISEASE. THE RECENTLY DEVELOPED QUANTITATIVE SUSCEPTIBILITY MAPPING (QSM) TECHNIQUE, WHICH CAN ACCURATELY MAP IRON DEPOSITS IN DEEP BRAIN NUCLEI, PROMISES PRECISE TARGETING OF THE STN. OBJECTIVE: TO DEMONSTRATE THE USE OF QSM TO TARGET STN EFFECTIVELY BY CORRELATING WITH CLASSICAL PHYSIOLOGICAL-BASED TARGETING MEASURES IN A PROSPECTIVE STUDY. METHODS: THE PRECISION AND ACCURACY OF DIRECT TARGETING WITH QSM WAS EXAMINED IN A TOTAL OF 25 PARKINSON'S DISEASE PATIENTS BETWEEN 2013 AND 2015 AT OUR INSTITUTION. QSM WAS UTILIZED AS THE PRIMARY MAGNETIC RESONANCE IMAGING (MRI) METHOD TO PERFORM DIRECT STN TARGETING ON A STEREOTACTIC PLANNING STATION UTILIZING COMPUTED TOMOGRAPHY/MR FUSION. INTRAOPERATIVE MICROELECTRODE RECORDINGS (MER) WERE OBTAINED TO CONFIRM APPROPRIATE TRAJECTORY THROUGH THE SENSORIMOTOR STN. RESULTS: ESTIMATIONS OF STN THICKNESS BETWEEN THE MER AND QSM METHODS APPEARED TO BE CORRELATED. MEAN STN THICKNESS WAS 5.3 MM. KINESTHETIC RESPONSIVE CELLS WERE FOUND IN > 90% OF ELECTRODE RUNS. THE MEAN RADIAL ERROR (+- SEM) WAS 0.54 +- 0.1 MM. SATISFACTORY CLINICAL RESPONSE AS DETERMINED BY UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS III) WAS SEEN AT 12 MO AFTER SURGERY. CONCLUSION: DIRECT TARGETING OF THE SENSORIMOTOR STN USING QSM DEMONSTRATES MER CORRELATION AND CAN BE SAFELY USED FOR DEEP BRAIN STIMULATION LEAD PLACEMENT WITH SATISFACTORY CLINICAL RESPONSE. THESE RESULTS IMPLY THAT TARGETING BASED ON QSM SIGNALING ALONE IS SUFFICIENT TO OBTAIN RELIABLE AND REPRODUCIBLE OUTCOMES IN THE ABSENCE OF PHYSIOLOGICAL RECORDINGS. REPORTED EVENTS: 1. A PATIENT WITH BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD) DEVELOPED A SYMPTOMATIC DELAYED UNILATERAL CHRONIC SUBDURAL HEMATOMA THAT WAS TREATED CONSERVATIVELY WITH A 6-WEEK ORAL DEXAMETHASONE TAPER AND SERIAL I MAGING. AS OF A 6-MONTH FOLLOW-UP CT SCAN THE HEMATOMA HAD RESOLVED. 2. 2 PATIENTS WITH BILATERAL STN-DBS FOR PD EXPERIENCED MILD ERYTHEMA AND TENDERNESS OF THE PARIETAL CONNECTOR INCISIONS. THIS WAS A PRESUMED MILD SUPERFICIAL INFECTION AND WAS TREATED WITH A 1-WEEK COURSE OF DOXYCYCLINE AND TOPICAL SILVER SULFADIAZINE. THE SYMPTOMS REPORTEDLY RESOLVED WITHOUT INCIDENT. THE AUTHORS REPORTED THAT ALL PATIENTS WERE IMPLANTED WITH ACTIVA SC DEVICES, HOWEVER THE PARTICULAR MODEL NUMBER WAS NOT PROVIDED, AND IT WAS NOT POSSIBLE TO ASCERTAIN ANY ADDITIONAL 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
    472905 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention