BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2849394 · Received November 28, 2012

    Report

    Report Number
    3007566237-2012-02852
    Event Type
    Injury
    Date Received
    November 28, 2012
    Date of Event
    October 5, 2012
    Report Date
    November 4, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389, SERIAL# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 3389, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. PATIENTS WERE IMPLANTED WITH EITHER KINETRA, ACTIVA PC, OR ACTIVA RC IMPLANTABLE NEUROSTIMULATORS. IT WAS UNKNOWN WHICH MODEL THIS PATIENT WAS IMPLANTED WITH. (B)(4).

    Description of Event or Problem · 1

    LITERATURE: RECK, C., MAAROUF, M., WOJTECKI, L., JUN GROISS, S., FLORIN, E., STURM, V., FINK, G. R., SCHNITZLER, A., TIMMERMANN, L. CLINICAL OUTCOME OF SUBTHALAMIC STIMULATION IN PARKINSON'S DISEASE IS IMPROVED BY INTRAOPERATIVE MULTIPLE TRAJECTORIES MICROELECTRODE RECORDING. JOURNAL OF NEUROLOGICAL SURGERY. PART A, CENTRAL EUROPEAN NEUROSURGERY. 2012;73(6):377-386. DOI: 10.1055/S-0032-1326957. SUMMARY: THE USE OF MULTIPLE TRAJECTORIES MICROELECTRODE RECORDING (MER) DURING IMPLANTATION OF DEEP BRAIN STIMULATION (DBS) ELECTRODES INTO THE SUBTHALAMIC NUCLEUS (STN) IN PATIENTS WITH PARKINSON'S DISEASE (PD) IS DISCUSSED CONTROVERSIALLY BECAUSE OF POSSIBLE RISKS AND UNCLEAR BENEFITS. THE AIM OF THE STUDY IS TO INVESTIGATE WHETHER MER COMBINED WITH INTRAOPERATIVE EVALUATION OF STIMULATION EFFECTS IMPROVE CLINICAL OUTCOME IN PD PATIENTS UNDERGOING STN DBS SURGERY. PRIOR TO FINAL DBS ELECTRODE IMPLANTATION, WE PERFORMED MULTIPLE TRAJECTORIES MER AND INTRAOPERATIVE TEST STIMULATIONS AFTER MAGNETIC RESONANCE IMAGING (MRI)-GUIDED PLANNING IN 32 PD PATIENTS. IN FURTHER 10 PATIENTS NO MER (ONLY INTRAOPERATIVE TEST STIMULATION) WAS USED. WE FOUND A SIGNIFICANTLY BETTER CLINICAL OUTCOME (UNIFIED PARKINSON'S DISEASE RATING SCALE [UPDRS] III) IN PATIENTS UNDERGOING MER COMPARED WITH NON-MER PATIENTS. IN MER PATIENTS, DBS ELECTRODE PLACEMENT WAS PERFORMED USING THE CENTRAL TRAJECTORY IN 73%. ANOTHER THAN THE CENTRAL TRAJECTORY WAS TAKEN IN 27% OF THE PATIENTS. NO DIFFERENCE IN CLINICAL OUTCOME BETWEEN DBS ELECTRODES IMPLANTED ON THE CENTRAL OR A DECENTRAL TRAJECTORY WAS OBSERVED. DBS SURGERY BASED ON INTRAOPERATIVE MULTIPLE TRAJECTORIES MER AND TEST STIMULATION IMPROVES CLINICAL OUTCOME IF COMPARED WITH INTRAOPERATIVE TEST STIMULATION ALONE. THE DATA SUGGEST THAT DBS SURGERY SOLELY BASED ON MRI AND INTRAOPERATIVE TEST STIMULATION WITHOUT MER MAY LEAD TO NON-OPTIMAL PLACEMENT OF DBS ELECTRODES AND CONSEQUENTLY POORER CLINICAL OUTCOME. REPORTED EVENT: CONCERNING COMPLICATIONS, WE OBSERVED A WOUND INFECTION AT THE GENERATOR POCKET THAT WAS SUCCESSFULLY TREATED BY ANTIBIOTICS IN PATIENT 37.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention