BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 24768113 · Received April 2, 2026

    Report

    Report Number
    2182207-2026-00884
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    January 16, 2026
    Report Date
    April 2, 2026
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MBX
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN: PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN: PETERS, P. A., ZHOU, R., SINGH, R., GREGG, N. M., WORRELL, G. A., LUNDSTROM, B. N., MILLER, K. J., <(>&<)> VAN GOMPEL, J. J. (2026). FOUR-LEAD DEEP BRAIN STIMULATION FOR MULTIFOCAL DRUG-RESISTANT EPILEPSY: SURGICAL SAFETY PROFILE AND PRELIMINARY EFFECTIVENESS. JOURNAL OF NEUROSURGERY, 1¿12. HTTPS://DOI.ORG/10.3171/2025.8.JNS251288 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 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 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 ¿FOUR-LEAD DEEP BRAIN STIMULATION FOR MULTIFOCAL DRUG-RESISTANT EPILEPSY: SURGICAL SAFETY PROFILE AND PRELIMINARY EFFECTIVENESS.¿ MULTIPLE MANUFACTURERS¿ DEVICES WERE IMPLANTED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: ACTIVA PC, ACTIVA PC+S, INTELLIS, PRIME ADVANCED, AND SUMMIT RC+S NEUROSTIMULATORS. AMONG ALL PATIENTS, ADVERSE EVENTS / DEVICE PRODUCT PERFORMANCE ISSUES INCLUDED: TWO PATIENTS REQUIRED INTRAOPERATIVE LEAD REPOSITIONING. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827255 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED MBX MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Female SEE H11...