BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

    MDR report key: 22669470 · Received July 30, 2025

    Report

    Report Number
    3004209178-2025-12942
    Event Type
    Malfunction
    Date Received
    July 30, 2025
    Date of Event
    May 2, 2025
    Report Date
    August 18, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000558826
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    G2: CORRECTION: MISSING PMA NUMBER. PMA NUMBER ADDED. (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. 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

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING AN IMPLANTABLE NEUROSTIMULATOR. THE REASON FOR CALL WAS PATIENT REPORTED THEIR UPPER THIGHS HURT WHEN THEY WALK, THEIR LEGS FEEL HEAVY, AND THEIR RIGHT HIP IS HURTING SOMETIMES REALLY BADLY. PATIENT STATED THEY DIDN'T HAVE THIS PRIOR TO THE IMPLANT AND INQUIRED IF "SIDE EFFECTS" WERE NORMAL. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. PATIENT REPORTED THEY HAD THEIR SPINAL STIMULATOR IMPLEMENTATION SURGERY ON (B)(6). UNTIL THE REMOVAL OF THE 23 STAPLES, THERE WERE MINOR DISCOMFORTS BUT ALSO, THERE WAS MINOR IMPROVEMENT IN PAIN IF ANY. PT DID NOTICE THAT THEY WERE ABLE TO STAND A MINIMAL AMOUNT LONGER. PT REMAINED OPTIMISTIC. AFTER THE STAPLES WERE REMOVED ON FRIDAY, (B)(6), A MEDTRONIC REPRESENTATIVE, MET THEM AND SHOWED THEM HOW TO INCREASE THEIR STIMULATION AND DID THAT FOR THEM. THE FOLLOWING MORNING, PT AWAKENED WITH VERY STRONG HIP JOINT PAIN ON THE RIGHT SIDE. PT HAD NOT HAD ANYTHING WRONG WITH THAT JOINT EXCEPT A FEW TWINGES PERIODICALLY. PT DO NOT TAKE PAIN PILLS OR OVER THE COUNTER PAIN MEDICATION DUE TO ULTRA-SENSITIVE STOMACH. PT DO TAKE SOME PAIN PILLS RIGHT AFTER SURGERY BUT ONLY WITH A PRESCRIPTION FOR MY STOMACH PROBLEM AS WELL. PT FINALLY SETTLED THE PAIN DOWN WITH A LIDOCAINE PATCH WHICH IS MY GO-TO PAIN MEDICATION WHEN APPROPRIATE. PT ALSO HAD SHARP BONE PAIN IN THEIR LEFT LOWER LEG. WHICH CONTINUED ON AND OFF THROUGHOUT THE DAY. SOME OF THIS IMPROVED THE NEXT DAY BUT THE UPPER THIGH PAIN WHILE WALKING BEGAN. EACH STEP HURT AT THE LEVEL OF HIGH MEDIUM PAIN FOR ABOUT TWO WEEKS IN BOTH LEGS UNTIL THEIR SETTINGS WERE INCREASED BY ANOTHER REPRESENTATIVE. PT ALSO EXPERIENCED NAUSEA, AND AN INTERMITTENT HEADACHE WITH PAIN IN BOTH SHOULDER JOINTS. PT FELT LIKE SOMETHING WAS "BURNING" INSIDE WHERE THE BATTERY WAS IMPLANTED. PT TRIED TO GET A HOLD OF THEIR REP BUT THERE WAS NO ANSWER TO SEVERAL CALLS. PT ASSUMED THEY DID NOT RESPOND ON WEEKENDS WHICH SHE LATER CONFIRMED. PT CALLED AN 800 NUMBER THAT THEY FOUND IN THE LITERATURE AND REQUESTED HELP. THE RESPONDENT STATED IF PT DID NOT HAVE A MECHANICAL PROBLEM THAT THEY COULD NOT HELP THEM. NO ONE EVER MENTIONED THE POSSIBILITY OF SIDE EFFECTS AND PT DID NOT KNOW TO ASK. PT WAITED UNTIL THE FOLLOWING MONDAY AND FINALLY REACHED THE REP AND ASKED HER TO TURN DOWN THE DEVICE BECAUSE IT FELT LIKE IT WAS BURNING THEM. PT TURNED IT DOWN TWICE AGAIN BEFORE THEIR APPOINTMENT ON (B)(6) FOR THEIR SURGERY FOLLOW-UP WITH DR. (B)(6). THERE WAS ALSO A DIFFERENT MEDTRONIC REPRESENTATIVE. REP TOLD THEM THAT PT WAS GOING THE WRONG WAY AND NEEDED TO TUM THE DEVICE UP NOT DOWN. PT WAS WILLING TO FIX IT AND DO WHATEVER IT TOOK. FORTUNATELY, IT DID NOT FEEL LIKE IT WAS BURNING THEM AGAIN. REP TOLD THEM HOW MANY TIMES AND WHEN TO INCREASE THE BASE AND PRIME NUMBERS AND HOW MANY DAYS TO WAIT IN BETWEEN. HE ALSO STATED THAT PT WOULD NEED TO CHARGE THE IMPLANTED BATTERY EVERY THREE DAYS. WHICH PT FEEL IS EXCESSIVE. PT KNOW THAT THE BATTERY APPARENTLY NEEDS TO BE CHARGED THAT OFTEN, BUT IT DOES SEEM THAT WEEKLY WOULD BE MORE REASONABLE AND LESS LIFE DISRUPTIVE. PT HAVE NOT BEEN ABLE TO STAY ON HIS RECOMMENDED SCHEDULE BECAUSE SOME DAYS PT CANNOT GET THE BASE/PRIME "WINDOW" TO OPEN IT JUST WON'T COME UP. EACH TIME PT HAVE CHANGED THE NUMBERS AND CHARGED THE BATTERY, SOME VERSION OF THEIR FIRST EXPERIENCE WITH ONE OR MORE OF THE SIDE EFFECTS CAUSING PHYSICAL PAIN HAPPENS. SOMETIMES ONLY A COUPLE OF SYMPTOMS APPEAR BUT SOMETIMES THEY ARE STRONG. PT DO SEEM TO BE STANDING A LITTLE LONGER. TODAY PT HAVE BACK PAIN AND LOWER LEG BONE PAIN AND MILD TO MEDIUM UPPER THIGH PAIN WHEN THEY WALK. PT SAW THEIR ORTHOPEDIST FOR A KNEE SHOT ON (B)(6) AND REQUESTED AN X-RAY OF THEIR HIP AND HE SAID THERE IS NOTHING THAT SHOULD BE GIVING THEM THIS PAIN. HE SAID THAT PT STILL HAVE GOOD BONE SEPARATION, SOME MINOR ARTHRITIS BUT NOT SIGNIFICANT. PT EVEN GET SOME REACTIONS IF THEY ONLY CHARGE THE BATTERY. THESE SYMPTOMS USUALLY SLOWLY DISSIPATE AFTER CHARGING AND CHANGING NUMBERS. IT WAS BETTER WHEN PT DID NOT HAVE TO CHARGE EVERY 3 DAYS. PT FIRST OF THE MORNING BACK PAIN HAS ACTUALLY INCREASED SINCE THEIR LAST CHARGE. THIS IS NOT UNIQUE, PT OFTEN HAVE NEW PAIN AND OLD PAIN. DR. (B)(6) WANTS TO SEE THEM AGAIN IN 3 MONTHS AND HE SAID TO CALL IF HE CAN GET INVOLVED AND HELP WITH MEDTRONIC. PT IS WONDERING IF IT IS IT POSSIBLE THAT THEIR EQUIPMENT IS SOMEHOW DEFECTIVE? REP SAID THAT HE WOULD CALL TODAY BUT HE HAS NOT. PT WAS GOING SHOPPING TODAY FOR THEIR 80TH BIRTHDAY, BUT PT DID NOT FEEL LIKE IT. SURLY PT THINKS THEY ARE NOT THE ONLY PERSON WITH A SIMILAR STORY. PT WANTS TO KNOW IF MEDTRONIC CAN HELP THEM. PT WANT THIS TO WORK! HOWEVER, IT IS STARTING TO SEEM LIKE NO ONE ELSE CARES IT IS JULY, AND PT HAVE BEEN MOSTLY IN PAIN SINCE MAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445825 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 977118 00763000558826

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female