BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 23575121 · Received November 17, 2025

    Report

    Report Number
    2182207-2025-03148
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    October 2, 2023
    Report Date
    December 9, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID 37612. SERIAL# (B)(6). IMPLANTED: (B)(6) 2023: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID B3400060M. SERIAL# (B)(6): EXPLANTED: (B)(6) 2024. PRODUCT TYPE EXTENSION PRODUCT ID B3400060. SERIAL# (B)(6). IMPLANTED: (B)(6) 2024: PRODUCT TYPE EXTENSION PRODUCT ID NEU_UNKNOWN_LEAD. SERIAL# UNKNOWN: PRODUCT TYPE LEAD 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.

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT A PATIENT HAD A SURGICAL WOUND WITH STAPLES IN SITU AND SMALL AREA OF ERYTHEMA WITHOUT DISCHARGE ON (B)(6) 2023, SO THEY WERE GIVEN TMP/SMX 160/800 MG. THE EXTENSION WAS EXPLANTED/REPLACED ON (B)(6) 2024. HOWEVER, THE PATIENT LATER REPORTED ON (B)(6) 2024 OF INFLAMMATION ALONG THE EXTENSION PATH THROUGH THE SCALP. THE SKIN BECAME RED AND HOT. THEY WERE GIVEN THE SAME MEDICATION AGAIN ON (B)(6) 2024. ON (B)(6) 2024, THERE WAS NOW PUS AND SYSTEM EROSION/EXPOSURE WITH RISK OF SUPERINFECTION INCLUDING INTRACRANIAL INFECTION. THE ENTIRE SYSTEM WAS EXPLANTED/REPLACED ON (B)(6) 2025 AND AGAIN ON (B)(6) 2025. THE ETIOLOGY WAS INDICATED AS POSSIBLY RELATED TO IMPLANT PROCEDURE INFECTION. THE EVENT ALSO RESULTED IN HOSPITALIZATION. THE ISSUE RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274950 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention| H