BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 22363142 · Received June 30, 2025

    Report

    Report Number
    2182207-2025-01676
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    May 1, 2025
    Report Date
    June 30, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 3889, SERIAL/LOT #: UNKNOWN, PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3889, SERIAL/LOT #: UNKNOWN. 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. B.3. PLEASE NOTE THAT 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. WANG, Y. ET AL. EFFECTS OF PNEUMOCEPHALUS ON ELECTRODE LOCATION AFTER DEEP BRAIN STIMULATION OF THE SUBTHALAMIC NUCLEUS IN PARKINSON DISEASE. WORLD NEUROSURG. 197, 123958 (2025). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING EFFECTS OF PNEUMOCEPHALUS ON ELECTRODE LOCATION AFTER DEEP BRAIN STIMULATION OF THE SUBTHALAMIC NUCLEUS IN PARKINSON DISEASE. THE FOLLOWING MEDTRONIC DEVICES WERE USED: KINETRA AND 3889 ELECTRODE. AMONG ALL PATIENTS ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: AMONG 111 PARKINSON'S DISEASE PATIENTS THE COORDINATES OF 2 DISTAL CONTACTS SHOWED STATISTICAL DIFFERENCES IN THE Y DIRECTION. SIGNIFICANT DIFFERENCES WERE OBSERVED IN THE COORDINATES OF ALL CONTACTS IN THE Z DIRECTION AS WELL SUGGESTING THAT AFTER PNEUMOCEPHALUS ABSORPTION, THE DISTAL ELECTRODE TENDS TO SHIFT FORWARD AND UPWARD. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2398926 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION 7428 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown