BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 25142889 · Received May 11, 2026

    Report

    Report Number
    2182207-2026-01243
    Event Type
    Injury
    Date Received
    May 11, 2026
    Report Date
    May 11, 2026
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). ON A REDDIT POST THE PATIENT REPORTED THAT THEY WERE TALKED INTO AN OCCIPITAL NERVE STIMULATOR, AND IT WAS "CRIMINAL" HOW THEIR PHYSICIAN WOULDN¿T TAKE IT OUT. WHEN THE PATIENT TURNED IT ON "IT FELT LIKE A DENTIST DRILL WAS DRILLING IN THE BACK OF MY NECK" AND THE PATIENT'S PHYSICIAN "KEPT INCREASING TO SHUT ME UP." THE PATIENT WENT TO OTHER SURGEONS TO TAKE IT OUT AND NO ONE WOULD. THE PATIENT ALLEGED THAT BY THE TIME THE PHYSICIAN RECEIVED THEIR KICKBACK FROM THE MANUFACTURER, THE PATIENT WAS UP TO FENTANYL 75 PATCHES EVERY TWO DAYS, 180 OXYCOTON 30 MG A MONTH, AND 180 DILAUDID 4 MG A MONTH. THE PHYSICIAN ALSO PRESCRIBED GABAPENTIN, TIZANIDINE, AND CLONAZEPAM. THEY TOOK THE MEDICATION EXACTLY AS PRESCRIBED. THE PATIENT ATTACHED A PICTURE OF THE "SCAR FROM OCCIPITAL STIMULATOR IMPLANTED AND THEN AGAIN TO TAKE IT OUT." THE PATIENT NOTED THAT THE PAIN IN THEIR NECK WAS EXCRUCIATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386374 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention