BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 24580926 · Received March 12, 2026

    Report

    Report Number
    2182207-2026-00647
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    March 8, 2026
    Report Date
    March 30, 2026
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID M995402A001, LOT# SERIAL# (B)(6), PRODUCT TYPE PRODUCT ID 97745AC LOT# 231901, PRODUCT TYPE ACCESSORY PRODUCT ID 97745 LOT# SERIAL# (B)(6), IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 97755 LOT# SERIAL# (B)(6) PRODUCT TYPE RECHARGER 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

    G2: THE COUNTRY OF THE EVENT IS JP 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

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE CAUSE OF THE LOSS OF STIMULATION IS UNKNOWN, BUT SINCE THE ORIGINAL SETTING WAS BELOW THE SENSORY THRESHOLD, IT IS PRESUMED THAT CHANGES IN POSTURE RESULTED IN THE PRESENCE OR ABSENCE OF STIMULATION SENSATION. THE CONTROLLER AND RECHARGER WERE REPLACED ON MAR-17. IT WAS NOTED THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER¿S REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE IT WAS REPORTED THAT THE STIMULATOR IS ABOUT TO BE CHARGED, BUT THE DEVICE SCREEN SHOWS UNNECESSARY INFORMATION (REMOTE CONTROL VIBRATES, CONFIRMATION, MRI MODE, TWO OK INDICATIONS, AND A LOCK ICON BEING DISPLAYED) AND DOES NOT SHOW THE USUAL SCREEN OR INDICATE CHARGING. THE CONTROLLER AND STIMULATOR BOTH CHARGE ABOUT 50%. AFTER REMOVING AND REINSERTING THE BATTERY PACK, THE SCREEN DISPLAYED NORMAL, SO PLEASE MONITOR THE SITUATION. THE REMAINING BATTERY LEVEL FOR BOTH THE CONTROLLER AND THE STIMULATOR WAS 50%, SO PLEASE CHARGE THE CONTROLLER AND THE STIMULATOR. IF THE DEVICE CANNOT BE CHARGED NORMALLY, PLEASE CONTACT AGAIN. IT WAS NOTED THE CONTROLLER ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. THE CONTROLLER WAS CHARGED TO 100% FIRST, THEN THE STIMULATOR WAS CHARGED, BUT IT PROGRESSED SLOWLY. THE CONTROLLER WAS 70% AND THE STIMULATOR WAS 60%. APPARENTLY, IN THE PAST FEW MONTHS, IT HAS BEEN TAKING TIME TO CHARGE THE STIMULATOR. APOLOGIES THAT THE ONLY SUGGESTIONS AVAILABLE WERE TO SEARCH FOR A POSITION WHERE THE CONDITION BECOMES VERY GOOD OR TO PLACE IT DIRECTLY AGAINST THE SKIN RATHER THAN OVER THE CURRENT UNDERGARMENT, AND ASKED THEM TO BE PATIENT AND CONTINUE USING IT. THE ATTENDING PHYSICIAN ONLY MUTTERED, ¿I WONDER IF THERE IS ANY GOOD METHOD,¿ AND NO ADVICE WAS PROVIDED EVEN WHEN CONSULTATION WAS SOUGHT DURING REGULAR OUTPATIENT VISIT. NO MENTIONS OF PROBLEM WITH THE DEVICE OR THE STIMULATION SYSTEM. IF THE MEDICAL INSTITUTION CONTACTS THE PERSON IN CHARGE, THE PERSON IN CHARGE MAY BE ABLE TO TAKE ACTION ACCORDING TO THE DETAILS, SO IT WAS INSTRUCTED TO CONSULT WITH THE MEDICAL INSTITUTION AGAIN. ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE STIMULATOR'S CHARGING CAPACITY DID NOT INCREASE THE OTHER DAY AND STIMULATION WAS NOT FELT. THE STIMULATOR WAS CHARGED FOR ABOUT 3 AND A HALF HOURS LAST NIGHT, BUT THE CONTROLLER'S CHARGE AMOUNT DECREASED FROM 100% TO 70%, BUT THE STIMULATOR'S CHARGE AMOUNT DID NOT INCREASE OR DECREASE FROM 80%. THE CHARGING LIGHT AT THE TOP OF THE SCREEN WAS BLINKING. ON MARCH 8, THE CC WAS CONSULTED AND TRIED CHANGING THE STIMULATOR SEVERAL TIMES, BUT IT DID NOT CHANGE. LAST NIGHT, THE BATTERY PACK WAS DETACHED AND ATTACHED. THE EVENT OCCURRED IN THE LAST 4 DAYS, AND THE PATIENT USUALLY FEELS STIMULATION FROM TIME TO TIME, BUT NOW STIMULATION WAS NOT FELT. STIMULATION OFF WAS NOT DISPLAYED. THE AREA IN CHARGE WAS ASKED TO HANDLE THE ISSUE. IT WAS NOTED THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638681 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 97715

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female "SEE H11...."| SEE H11...