BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 24363921 · Received February 17, 2026

    Report

    Report Number
    3004209178-2026-02574
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    January 23, 2026
    Report Date
    February 17, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    003

    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 (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PT STATED THAT THE AREA WHERE THE INS WAS LOCATED WAS REAL PAINFUL AND WAS TURNING BLACK SINCE THE INS WAS LOOSE. PT SAID THAT THEY SPOKE WITH HEALTHCARE PROVIDER (HCP) NURSE AND THAT THEY WERE WAITING ON A REFERRAL FROM THEIR PCP SINCE IT HAD BEEN OVER A YEAR SINCE THEY HAD SEEN HCP, HOWEVER IT HAD BEEN A WHOLE WEEK AND THE PCP ENDED UP SENDING A REFERRAL OVER TO A WHOLE DIFFERENT DOCTOR THAT DIDN'T EVEN DO THE IMPLANTING SURGERY. PATIENT THEN SAID THAT HCP TOLD THEM TO CALL PATIENT SERVICES TO SEE IF PS COULD GET THEM OVER TO SEE THE HCP AS SOON AS POSSIBLE SINCE THEY WERE TOLD THAT THE INS AREA WAS EITHER INFECTED OR THE INS BATTERY WAS LEAKING. PATIENT NOTED THAT THE PAIN WAS EVERY DAY AND THAT IT SEEMED LIKE IT WAS GETTING WORSE. AGENT REVIEWED PS'S ROLE AND REDIRECTED PT TO HCP. WHEN ASKED FOR THE EVENT DATE, PATIENT SAID IT HAD BEEN ABOUT A WEEK NOW. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT (PT). PT CLARIFIED THEY ARE SCHEDULED ON (B)(6) 2026 WITH HEALTHCARE PROVIDER (HCP), FOR THEM TO "LOOK AT IT" AGENT UNDERSTOOD THE DEVICE. PT REPORTED THAT AT THIS APPOINTMENT THEY ARE SUPPOSED TO SCHEDULE A DEVICE EXPLANT, PT WOULD LIKE TO LIMIT SURGERIES RELATED TO THEIR IMPLANTABLE NEUROSTIMULATOR (INS)/SPINAL CORD STIMULATOR. PT ALSO REPORTED THEY "DON'T REALLY USE IT VERY MUCH". PT ALSO REPORTED TURNING ON THEIR STIMULATOR IN AN ATTEMPT TO RELIEVE THEIR PAIN AROUND THE IMPLANT SITE. PT REPORTED TURNING THE IMPLANT ON MADE THEIR PAIN WORSE, SO THEY PUT THEIR IMPLANT IN MRI MODE DUE TO THIS. PT CALLED HCP AND ASKING IF IT WAS NORMAL TO BE EXPERIENCING THOSE ISSUES, THEN WAS URGED TO GO TO THE EMERGENCY ROOM. PT SPENT 8 HOURS IN THE EMERGENCY ROOM AND RECEIVED A PAIN PILL AND TWO SHOTS FOR THEIR PAIN BEFORE BEING SENT HOME WITH PLAN TO FOLLOW UP WITH HCP. PATIENT CLARIFIED NO DIAGNOSTIC IMAGING/PROCEDURES WERE PERFORMED, AND NO ANTIBIOTICS WERE PRESCRIBED FOR THESE ISSUES. PT REPORTED THAT THE CAUSE WAS NOT DETERMINED AT THIS TIME AND THEY DID NOT KNOW IF IT WAS AN INFECTION OR IF THE BATTERY WAS LEAKING. WHEN PROMPTED ON IF THIS ISSUE WAS STILL ONGOING. PT REPORTED THE SWELLING HAS IMPROVED AND CAN BE HEARD ON THE CALL ASKING ANOTHER PERSON, THEN REPORTING IT WAS NO LONGER BLACK AROUND THE IMPLANT SITE. PT ALSO REPORTED AN MRI ON THE (B)(6) FOR "SOMETHING DIFFERENT IN MY BACK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431570 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Female Required Intervention