BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 18615476 · Received January 31, 2024

    Report

    Report Number
    2182207-2024-00356
    Event Type
    Injury
    Date Received
    January 31, 2024
    Date of Event
    December 22, 2023
    Report Date
    January 31, 2024
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: 3387. PRODUCT TYPE: LEAD PRODUCT ID: 3387. PRODUCT TYPE: LEAD SECTION D: INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387; PRODUCT ID: 3387. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    HOLD FOR RW 1.31 (B)(6). REVIEW OF THE TARGETING ACCURACY OF FRAMELESS AND FRAME BASED ROBOT ASSISTED DEEP BRAIN STIMULATION ELECTRODE IMPLANTATION IN PEDIATRIC PATIENTS USING THE NEUROLOCATE MODULE. JOURNAL OF NEUROSURGERY. DOI: (B)(6) 2023. OBJECTIVE: THE NEUROLOCATE MODULE IS A 3D: FRAMELESS PATIENT REGISTRATION MODULE THAT IS DESIGNED FOR USE WITH THE NEUROMATE STEREOTACTIC ROBOT. LONGTERM ELECTRICAL STIMULATION OF THE GLOBUS PALLIDUS INTERNUS (GPI) AND SUBTHALAMIC NUCLEUS (STN) VIA DEEP BRAIN ELECTRODE IMPLANTATION IS PARTICULARLY SUCCESSFUL IN A SELECT GROUP OF MOVEMENT DISORDERS IN PEDIATRIC PATIENTS. THIS STUDY AIMED TO REVIEW THE TARGETING ACCURACY OF DEEP BRAIN STIMULATION (DBS) ELECTRODE IMPLANTATION IN A SINGLE CENTER, COMPARING STANDARD FRAME-BASED TECHNIQUES TO THE FRAMELESS NEUROLOCATE MODULE. METHODS TWENTY-FOUR PEDIATRIC PATIENTS UNDERWENT IMPLANTATION OF BILATERAL DBS ELECTRODES UNDER GENERAL ANESTHESIA DURING THE PERIOD OF AUGUST 2018 ¿ AUGUST 2022. ALL PATIENTS UNDERWENT ROBOT ASSISTED STEREOTACTIC IMPLANTATION OF DBS ELECTRODES USING AN INTRAOPERATIVE O-ARM 3D SCANNER TO CONFIRM THE FINAL ELECTRODE POSITION. THESE COORDINATES WERE COMPARED WITH THE PLANNED ENTRY AND TARGET, WITH ATTENTION TO DEPTH, RADIAL, DIRECTIONAL, AND ABSOLUTE ERRORS, IN ADDITION TO EUCLIDEAN DISTANCE (ED). THE PRIMARY OUTCOME EVALUATED THE ACCURACY AND SAFETY OF THE NEUROLOCATE FRAMELESS TECHNOLOGY COMPARED WITH STANDARD FRAME-BASED TECHNIQUES. RESULTS OF THE 24 BILATERAL DBS ELECTRODE IMPLANTATIONS PERFORMED, 62.5% USED NEUROLOCATE TECHNOLOGY: 8 7.5% WERE DELIVERED TO THE GPI AND THE REMAINING 12.5% TO THE STN. THE MEAN PATIENT AGE WAS 11.0 (RANGE 4¿18) YEARS AND 70.8% WERE MALE. THE MEDIAN ABSOLUTE ERRORS IN X-, Y-, AND Z-AXES WERE 0.35, 0.75, AND 0.9 MM, RESPECTIVELY, USING THE NEUROLOCATE MODULE COMPARED WITH 0.30, 0.95, AND 1.1 MM USING THE STANDARD FRAME-BASED TECHNIQUE. THE MEDIAN ED FROM THE PLANNED TARGET TO THE ACTUAL ELECTRODE POSITION WITH THE NEUROLOCATE MODULE WAS 1.28 MM VERSUS 1.69 MM USING STANDARD FRAME BASED TECHNIQUES. NO MAJOR PERIOPERATIVE COMPLICATIONS OCCURRED. CONCLUSIONS STEREOTACTIC ROBOT ASSISTED DBS IMPLANTATION WITH THE FRAMELESS NEUROLOCATE MODULE IS SAFE FOR USE IN THE PEDIATRIC POPULATION, SHOWING GOOD SURGICAL ACCURACY AND NO INFERIORITY TO STANDARD FRAME-BASED TECHNIQUES. THE NEUROLOCATE MODULE FOR ROBOTIC DBS SURGERY HAS THE POTENTIAL TO IMPROVE SURGICAL TARGETING ACCURACY, SURGICAL TIME, PATIENT COMFORT, AND SAFETY REPORTED EVENTS: 1. IT WAS REPORTED THAT ONE OF THE PATIENTS SUSTAINED A WOUND INFECTION REQUIRING TEMPORARY BILATERAL DBS ELECTRODE EXPLANTATION. 2. IT WAS REPORTED THAT TWO PATIENTS UNDERWENT ADJUSTMENT OF THE ELECTRODE DEPTH AT THE TIME OF THE POST-IMPLANTATION INTRAOPERATIVE O-ARM SCAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491002 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention "SEE H10"