BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 2614493 · Received June 13, 2012

    Report

    Report Number
    3007566237-2012-01334
    Event Type
    Injury
    Date Received
    June 13, 2012
    Date of Event
    December 8, 2011
    Report Date
    May 16, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389, LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYP LEAD. (B)(4). THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: TOLEIKIS, J.R., METMAN, L.V., PILITSIS, J.G., BARBORICA, A., TOLEIKIS, S.C., BAKAY, R.A.. EFFECT OF INTRAOPERATIVE SUBTHALAMIC NUCLEUS DBS ON HUMAN SINGLE-UNIT ACTIVITY IN THE IPSILATERAL AND CONTRALATERAL SUBTHALAMIC NUCLEUS. J NEUROSURG. 2012;116(5):1134-1143. SUMMARY: THE PURPOSE OF THIS STUDY WAS TO DETERMINE THE EFFECTS OF DBS STIMULATION ON SINGLE UNIT ACTIVITY ACQUIRED FROM PATIENTS UNDERGOING NEW OR REVISED DBS PLACEMENTS. SUBTHALAMIC NUCLEUS SINGLE UNIT ACTIVITY WAS ACQUIRED FROM AWAKE PATIENTS DURING ACTIVATION OF A PREVIOUSLY IMPLANTED STN DBS ELECTRODE. STIMULATION WAS CONTRALATERAL TO THE RECORDING SITE IN 4 CASES AND IPSILATERAL IN 3. DATA WERE ACQUIRED AT STIMULATION FREQUENCIES OF 30, 60, AND 130 HZ AND WITH OTHER STIMULATION PARAMETERS AT CLINICALLY EFFECTIVE SETTINGS. CELLS WERE INCLUDED IF THEY SHOWED KINESTHETIC ACTIVITY BEFORE AND AFTER THE STIMULATION PARADIGM AND IF THEIR ACTION POTENTIAL MORPHOLOGY WAS MAINTAINED THROUGHOUT THE EXPERIMENT. ANALYSIS OF SINGLE-UNIT ACTIVITY ACQUIRED BEFORE, DURING, AND AFTER STIMULATION WAS PERFORMED EMPLOYING A TIME-DOMAIN ALGORITHM TO OVERCOME THE STIMULUS ARTIFACT. BOTH IPSILATERAL AND CONTRALATERAL ACUTE STIMULATION RESULTED IN REVERSIBLE STN FIRING RATE SUPPRESSION. THE DEGREE OF SUPPRESSION BECAME GREATER AS STIMULUS FREQUENCY INCREASED AND WAS SIGNIFICANT AT 60 HZ (T-TEST, P - 0.05) AND 130 HZ (P -0.01). SUPPRESSION WITH IPSILATERAL 130-HZ STIMULATION RANGED BETWEEN 52.8% AND 99.8%, WHEREAS WITH SIMILAR CONTRALATERAL STN STIMULATION, THE RANGE WAS LOWER (1.9%-50.3%). RETURN TO BASELINE ACTIVITY LEVELS TYPICALLY OCCURRED WITHIN SECONDS AFTER STIMULATION ENDED. STIMULATION OF THE STN AT CLINICALLY EFFECTIVE FREQUENCIES HAS AN ACUTE SUPPRESSIVE RATHER THAN AN EXCITATORY EFFECT ON STN SINGLE-UNIT ACTIVITY. THE EFFECT IS BILATERAL, EVEN THOUGH THE DEGREE OF SUPPRESSION IS GREATER ON THE IPSILATERAL THAN THE CONTRALATERAL STN. THE AUTHORS' ALGORITHM HELPS REVEAL THIS EFFECT IN HUMAN PATIENTS. REPORTED EVENT: PATIENT 2, (B)(6) MALE, UNDERWENT A LEFT LEAD REVISION. THE LEAD HAD BEEN PROPERLY LOCATED IN THE STN, BUT WAS REPOSITIONED IN ORDER TO REDUCE SIDE EFFECTS THAT LIMITED THE ABILITY TO INCREASE STIMULATION INTENSITY OVER TIME. 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
    1 NEU_INS_STIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention