BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 13113120 · Received December 29, 2021

    Report

    Report Number
    1723170-2021-02984
    Event Type
    Malfunction
    Date Received
    December 29, 2021
    Date of Event
    October 14, 2021
    Report Date
    December 29, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AGE OR DATE OF BIRTH: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    RAJESH ALUGOLU, SWAPNIL KOLPAKWAR, VIJAYASARADHI MUDUMBA, ABHISHEK ARORA, RUKMINI KANDADAI, RUPAM BORGOHAIN. PROSPECTIVE ANALYSIS OF GROSS AND FINE MOTOR MANIFESTATIONS FOLLOWING STN- DBS AND THEIR CORRELATION WITH ELECTRODE POSITION. DOI: 10.23736/S0390-5616.21.05461-8. ABSTRACT BACKGROUND: DEEP BRAIN STIMULATION (DBS) HAS BEEN PROVEN TO BE A SAFE, REVERSIBLE, COST EFFECTIVE PROCEDURE FOR TREATMENT OF PARKINSON'S DISEASE. FINAL ELECTRODE POSITION REMAINS A SIGNIFICANT FACTOR DETERMINING THE OUTCOMES OF SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN-DBS). THIS STUDY AIMS TO ANALYZE THE FINAL LEAD POSITION IN THREE-DIMENSIONAL PLANE AND ITS EFFECT ON GROSS AND FINE MOTOR OUTCOMES IN CASES OF ADVANCED PARKINSON'S DISEASE OPERATED FOR STN-DBS. METHODS: PATIENTS WHO UNDERWENT BILATERAL STN DBS WERE PROSPECTIVELY FOLLOWED FOR IMPROVEMENT IN GROSS MOTOR OUTCOMES AT 6 MONTHS. IMPROVEMENT IN DYSGRAPHIA WAS ANALYZED BY FAHN-TOLOSA-MARIN TREMOR RATING SCALE PART B SCORE. POSTOPERATIVE OUTCOMES WERE CORRELATED WITH FINAL ELECTRODE POSITION. RESULTS: A TOTAL OF 64 PATIENTS (128 LEADS) WERE ANALYZED. PATIENTS WHO WERE LESS THAN 65 YEARS OF AGE AT TIME OF SURGERY HAD MORE SIGNIFICANT REDUCTION IN UPDRS III(P = 0.02). CASES WITH DEVIATION OF LEFT X LESS THAN 3 MM HAD SIGNIFICANT REDUCTION IN UPDRS III (P = 0.05) AND SPEECH SUB-SCORES (P = 0.05). DEVIATION LESS THAN 2 MM IN LEFT X WAS ASSOCIATED WITH REDUCTION IN GAIT SUB-SCORES (P = 0.04). OPTIMAL PLACEMENT OF RIGHT Y ELECTRODE WAS ASSOCIATED WITH REDUCTION IN UPDRS III (P = 0.02). SIGNIFICANT REDUCTION IN FAHN-TOLOSA-MARIN TREMOR RATING SCALE PART B SCORE WAS NOTED AFTER DBS(P =0.001).CONCLUSIONS: SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION THUS RESULTS IN SIGNIFICANTLY IMPROVED FUNCTIONAL OUTCOME PARTICULARLY IN PATIENTS WITH AGE LESS THAN 65 YEARS. ACCURATE FINAL ELECTRODE POSITION IS ASSOCIATED WITH MAXIMUM CLINICAL BENEFIT AND IMPROVEMENT IN DYSGRAPHIA. REPORTED EVENTS: IT WAS REPORTED THAT 7 PATIENTS HAD DEVIATIONS OF MORE THAN 3MM OF THE ELECTRODES. IT WAS REPORTED THAT THERE WERE AT LEAST 2 PATIENTS WITH MORE THAN 4 MM OF DEVIATION IN THEIR ELECTRODE. IT WAS REPORTED THAT THERE WERE 15 PATIENTS WITH MORE THAN 2MM OF DEVIATION IN THEIR ELECTRODE. IT WAS NOT POSSIBLE TO ASCERTAIN 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
    2009165 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male