BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 14518394 · Received May 26, 2022

    Report

    Report Number
    1723170-2022-00819
    Event Type
    Injury
    Date Received
    May 26, 2022
    Date of Event
    January 17, 2022
    Report Date
    May 26, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY. THIS VALUE REFLECTS THE MEDIAN AGE OF THE PATIENTS WHO UNDERWENT THE DBS PROCEDURE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE MAJORITY GENDER OF THE PATIENTS WHO UNDERWENT THE DBS PROCEDURE AS SPECIFIC PATIENTS COULD NOT BE IDENTI FIED. THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE ACCEPTED DATE. THE ARTICLE CITATION IS INCLUDED. THE NAVIGATION SYSTEM WAS A STEALTH STATION. THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO 510K PROVIDED AS SYSTEM IS UNKNOWN. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ZHENG, ZHE, ET AL. ¿THE ACCURACY OF IMAGING GUIDED TARGETING WITH MICROELECTRODE RECODING IN SUBTHALAMIC NUCLEUS FOR PARKINSON¿S DISEASE: A SINGLE-CENTER EXPERIENCE.¿ JOURNAL OF PARKINSON'S DISEASE, VOL. 12, NO. 3, 2022, PP. 897¿903., HTTPS://DOI.ORG/10.3233/JPD-213095. SUMMARY: BACKGROUND: ACCURATE ELECTRODE TARGETING WAS ESSENTIAL FOR THE EFFICACY OF DEEP BRAIN STIMULATION (DBS). THERE IS ONGOING DEBATE ABOUT THE NECESSARY OF MICROELECTRODE RECORDING (MER) IN SUBTHALAMIC NUCLEUS (STN)-DBS SURGERY FOR ACCURATE TARGETING. OBJECTIVE: THIS STUDY AIMED TO ANALYZE THE ACCURACY OF IMAGING-GUIDED AWAKE DBS WITH MER IN STN FOR PARKINSON¿S DISEASE IN A SINGLE CENTER. METHODS: THE AUTHORS PERFORMED A RETROSPECTIVE ANALYSIS OF 161 PARKINSON¿S DISEASE PATIENTS UNDERGOING STN-DBS AT OUR CENTER FROM MARCH 2013 TO JUNE 2021. THE IMPLANTATION WAS PERFORMED BY PREOPERATIVE MAGNETIC RESONANCE IMAGING (MRI)- BASED DIRECT TARGETING WITH INTRAOPERATIVE MER AND MACROSTIMULATION TESTING. 285 ELECTRODE TRACKS WITH PREOPERATIVE AND POSTOPERATIVE COORDINATES WERE INCLUDED TO CALCULATE THE PLACEMENT ERROR IN STN TARGETING. RESULTS: 85.9% OF ELECTRODES GUIDED BY PREOPERATIVE MRI WERE IMPLANTED WITHOUT INTRAOPERATIVE ADJUSTMENT. 31 (10.2%) AND 12 (3.9%) ELECTRODES UNDERWENT INTRAOPERATIVE ADJUSTMENT DUE TO MER AND INTRAOPERATIVE TESTING, RESPECTIVELY.WE FOUND 86.2% (245/285) OF ELECTRODES WITH TRAJECTORY ERROR=2 MM. THEMERPHYSIOLOGICAL SIGNALS LENGTH <(><<)> 4MMAND=4MMGROUP SHOWED TRAJECTORY ERROR > 2MM IN 38.0% AND 8.8% OF ELECTRODES, RESPECTIVELY. COMPARED TO NON-ADJUSTMENT ELECTRODES, THE FINAL POSITIONING OF MER-ADJUSTED ELECTRODES DEVIATED FROM THE CENTER OF STN. CONCLUSION: THE PREOPERATIVE MRI GUIDED STN TARGETING RESULTS IN APPROXIMATELY 14% CASES THAT REQUIRE ELECTRODE REPOSITIONING. MER P HYSIOLOGICAL SIGNALS LENGTH <(><<)> 4MM AT FIRST PENETRATION IMPLIED DEVIATION OFF PLANNED TARGET. MER COMBINED WITH INTRAOPERATIVE AWAKE TESTING SERVED TO RESCUE SUCH DEVIATION BASED ON MRI ALONE. REPORTED EVENT: ONE HUNDRED AND FIFTY-FIVE PATIENTS HAD A HISTOLOGY OF PARKINSON'S DISEASE UNDERWENT A DBS PROCEDURE. IN THE LEFT HEMISPHERE SIXTEEN ELECTRODES HAD A TRAJECTORY ERROR. NINETEEN ELECTRODES WERE FOUND TO HAVE A TRAJECTORY ERROR IN THE LEFT HEMISPHERE. TWENTY TWO ELECTRODES WERE FOUND TO HAVE A TRAJECTORY ERROR IN THE RIGHT HEMISPHERE. ALL OF THESE DOCUMENTED TRAJECTORY ERRORS WERE GREATER THAN 2MM, BUT LESS THAN 3.5MM. APPROXIMATELY FOURTEEN PERCENT OF ALL ELECTRODES HAD TO BE REPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2785729 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention