BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 18914294 · Received March 15, 2024

    Report

    Report Number
    2182207-2024-01850
    Event Type
    Injury
    Date Received
    March 15, 2024
    Date of Event
    February 9, 2024
    Report Date
    March 15, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN. RAGUZ, M., MARCINKOVIC, P., CHUDY, H., ORESKOVIC, D., LAKIC, M., DLAKA, D., KATAVIC, N., RACKI, V., VULETIC, V., CHUDY, D. DECREASED BRAIN VOLUME MAY BE ASSOCIATED WITH THE OCCURRENCE OF PERI-LEAD EDEMA IN PARKINSON¿S DISEASE PATIENTS WITH DEEP BRAIN STIMULATION. PARKINSONISM AND RELATED DISORDERS 121 (2024). DOI: 10.1016/J.PARKRELDIS.2024.106030. A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. B.5. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. 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

    RAGUZ, M., MARCINKOVIC, P., CHUDY, H., ORESKOVIC, D., LAKIC, M., DLAKA, D., KATAVIC, N., RACKI, V., VULETIC, V., CHUDY, D. DECREASED BRAIN VOLUME MAY BE ASSOCIATED WITH THE OCCURRENCE OF PERI-LEAD EDEMA IN PARKINSON¿S DISEASE PATIENTS WITH DEEP BRAIN STIMULATION. PARKINSONISM AND RELATED DISORDERS 121 (2024). DOI: 10.1016/J.PARKRELDIS.2024.106030. SUMMARY: BACKGROUND: PERI-LEAD EDEMA (PLE)IS A POORLY UNDERSTOOD COMPLICATION OF DEEP BRAIN STIMULATION (DBS), WHICH HAS BEEN DESCRIBED IN PATIENTS PRESENTING OCCASIONALLY WITH PROFOUND AND OFTEN DELAYED SYMPTOMS WITH AN INCIDENCE RANGING FROM 0.4% UP TO EVEN 100%. THEREFORE, OUR STUDY AIMS TO INVESTIGATE THE ASSOCIATION OF BRAIN AND BRAIN COMPARTMENT VOLUMES ON MAGNETIC RESONANCE IMAGING (MRI) WITH THE OCCURRENCE OF PLE IN PARKINSON¿S DISEASE (PD) PATIENTS AFTER DBS IMPLANTATION IN SUBTHALAMIC NUCLEI (STN). METHODS: THIS RETROSPECTIVE STUDY INCLUDED 125 CONSECUTIVE PD PATIENTS WHO UNDERWENT STN DBS AT THE DEPARTMENT OF NEUROSURGERY, DUBRAVA UNIVERSITY HOSPITAL FROM 2010 TO 2022. QUALITATIVE ANALYSIS WAS DONE ON POSTOPERATIVE MRI T2-WEIGHTED SEQUENCE BY TWO INDEPENDENT OBSERVERS, MARKING PLE ON MIDBRAIN, THALAMUS, AND SUBCORTICAL LEVELS AS MILD, MODERATE, OR SEVERE. QUANTITATIVE VOLUMETRIC ANALYSIS OF BRAIN AND BRAIN COMPARTMENT VOLUMES WAS CONDUCTED USING AN AUTOMATED CIVET PROCESSING PIPELINE ON PREOPERATIVE MRI T1 MPRAGE SEQUENCES. IN ADDITION, OBSERVED PLE ON INDIVIDUAL HEMISPHERES WAS DELINEATED MANUALLY AND MEASURED USING ANALYZE 14.0 SOFTWARE. RESULTS: IN OUR COHORT, PLE WAS OBSERVED IN 32.17%, MOSTLY BILATERALLY. MILD PLE WAS OBSERVED IN THE MAJORITY OF PATIENTS, REGARDLESS OF THE LEVEL OBSERVED. AGE, SEX, DIABETES, HYPERTENSION, VASCULAR DISEASE, AND THE USE OF ANTICOAGULANT/ANTIPLATELET THERAPY SHOWED NO SIGNIFICANT ASSOCIATION WITH THE OCCURRENCE OF PLE. TOTAL GREY MATTER VOLUME SHOWED A SIGNIFICANT ASSOCIATION WITH THE PLE OCCURRENCE (R = - 0.22, P = 0.04), AS WELL AS CORTEX VOLUME (R = - 0.32, P = 0.0005). CORTICAL VOLUMES OF HEMISPHERES, OVERALL HEMISPHERE VOLUMES, AS WELL AS HEMISPHERE/TOTAL INTRACRANIAL VOLUME RATIO SHOWED SIGNIFICANT ASSOCIATION WITH THE PLE OCCURRENCE. FURTHERMORE, THE VOLUME OF THE CORTEX AND TOTAL GREY VOLUME REPRESENT MODERATE INDICATORS, WHILE HEMISPHERE VOLUMES, CORTICAL VOLUMES OF HEMISPHERES, AND HEMISPHERE/TOTAL INTRACRANIAL VOLUME RATIO REPRESENT MILD TO MODERATE INDICATORS OF POSSIBLE PLE OCCURRENCE. CONCLUSION: THE RESULTS OF OUR STUDY SUGGEST THAT THE MORPHOMETRIC MRI MEASUREMENTS, AS A USEFUL TOOL, CAN PROVIDE RELEVANT INFORMATION ABOUT THE STRUCTURAL STATUS OF THE BRAIN IN PATIENTS WITH PD AND REPRESENT MODERATE INDICATORS OF POSSIBLE PLE OCCURRENCE. IDENTIFYING PATIENTS WITH GREATER BRAIN ATROPHY, ESPECIALLY REGARDING GREY MATTER BEFORE DBS IMPLANTATION, WILL ALLOW US TO ESTIMATE THE POSSIBLE POSTOPERATIVE SYMPTOMS AND INTERVENE IN A TIMELY MANNER. FURTHER STUDIES ARE NEEDED TO CONFIRM OUR FINDINGS AND TO INVESTIGATE OTHER POTENTIAL PREDICTORS AND RISK FACTORS OF PLE OCCURRENCE. REPORTED EVENTS: 1. ONE PATIENT IMPLANTED WITH DBS EXPERIENCED SEVERE PLE, AT ALL LEVELS IN ONE HEMISPHERE. THIS PATIENT PRESENTED WITH HEMIPARESIS. THE PATIENT UNDERWENT CORTICOSTEROID THERAPY UNSUCCESSFULLY, RESULTING IN DBS SYSTEM EXTRACTION THREE MONTHS AFTER THE SURGERY. SPECIFIC DEVICE INFORMATION PROVIDED IN THE ARTICLE INCLUDE THE 3387 AND 3389 LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1266095 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Unknown Required Intervention SEE H11