BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

    MDR report key: 23073949 · Received September 17, 2025

    Report

    Report Number
    3004209178-2025-15732
    Event Type
    Malfunction
    Date Received
    September 17, 2025
    Date of Event
    September 10, 2025
    Report Date
    September 25, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H2: CORRECT TO P840001. 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID TM91SCS2, SERIAL# (B)(4). 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 THEY SUDDENLY GOT SHOCKING SENSATIONS DOWN THEIR LEG (B)(4), SO THEY WANTED TO TURN STIMULATION DOWN BUT THEIR COMMUNICATOR WAS NOT WORKING OR POWERING ON OR ALLOW THEM TO CONNECT TO THE MYSTIM APP. PATIENT'S SPOUSE WAS ALSO ASSISTING WITH TROUBLESHOOTING. CALLER SAID THE GREEN LIGHT WAS FLASHING SLOWLY ON THE COMMUNICATOR AND THEY KEPT GETTING PROMPTING TO SCAN/ENTER THE COMMUNICATOR SERIAL NUMBER. AGENT HAD CALLER ATTEMPT TO ENTER THE SERIAL NUMBER MANUALLY, BUT THEN THEY KEPT GETTING 'NOT FOUND: COMMUNICATOR' MESSAGE. AGENT ASKED, CALLERS CONFIRMED THE PATIENT HAD BEEN WITHIN CLOSE PROXIMITY TO THE EQUIPMENT WHILE ATTEMPTING CONNECTION. CALLER TRIED RESETTING COMMUNICATOR BY HOLDING DOWN POWER BUTTON, BUT THE LIGHT KEPT SLOWLY PULSING GREEN. CALLER PLUGGED COMMUNICATOR INTO AC POWER SUPPLY, AND THE LIGHT ON COMMUNICATOR STARTED TO FLASH GREEN FASTER, SHOWING IT WAS RESPONSIVE AND CHARGING. AFTER UNPLUGGING FROM AC POWER, THE LIGHT STAYED SOLID GREEN. AGENT HAD THE CALLER TRY TO RESET THE COMMUNICATOR AGAIN, BUT THE COMMUNICATOR DID NOT START FLASHING DIFFERENT COLORS WHILE THE BUTTON WAS PRESSED DOWN, AND THEY COULD STILL NOT CONNECT. THE ISSUE WAS NOT RESOLVED. A REQUEST WAS SENT TO THE REPAIR DEPARTMENT TO REPLACE THE COMMUNICATOR. INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT REPORTED THAT THEY SUDDENLY GOT SHOCKING SENSATIONS DOWN THEIR LEG, SO THEY WANTED TO TURN STIMULATION DOWN BUT THEIR COMMUNICATOR WAS NOT WORKING OR POWERING ON OR ALLOW THEM TO CONNECT TO THE MYSTIM APP. AFTER TROUBLESHOOTING, PATIENT WAS STILL UNABLE TO CONNECT TO THE MYSTIM APPLICATION AND ADJUST STIM. CALLER SAID THEY FELT DISCOMFORT BUT THEY WEREN'T NECESSARILY IN A LOT OF PAIN. AGENT REDIRECTED THE PATIENT TO CONTACT THEIR HEALTHCARE PROVIDER (HCP) AND SEE IF A MANUFACTURING REPRESENTATIVE MIGHT BE ABLE TO MEET WITH THEM TO TURN THE STIMULATION DOWN/OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531168 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 977118

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male