BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 23960939 · Received January 5, 2026

    Report

    Report Number
    3004209178-2026-00125
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 9, 2025
    Report Date
    January 5, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315467
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 REPORTED THEIR STIMULATOR QUIT WORKING THIS MORNING. PT STATED IT DOESN'T 'BUZZ' ANYMORE AND THEY ARE FEELING A LITTLE PAIN. PT MENTIONED THEY SAW THE SETTINGS NOT AVAILABLE CANNOT PROVIDE DESIRED INTENSITY SETTINGS MESSAGE. AGENT INSTRUCTED PT TO TRY A DIFFERENT GROUP. PT SAID THEY WERE IN GROUP B WITH PROGRAM 1 AND CONFIRMED THAT THE THERAPY WAS ON. PT TRIED GROUP C BUT WAS NOT ALLOWING THEM TO CHANGE THE INTENSITY IN PROGRAM 1 AND SAME THING HAPPENED WITH GROUP A. PT SAID THEY WANTED A WHOLE NEW CONTROLLER AND RECHARGER. AGENT REVIEWED INFORMATION. PT STATED IT WILL TAKE A LOT OF TIME TO GET A REP AND THEY WILL BE IN A LOT OF PAIN. WHEN ASKED FOR HEALTHCARE PROVIDER (HCP) INFO PT SAID THEIR DOCTOR ALREADY RETIRED AND SAID THEIR PREVIOUS HCP HAS A PARTNER AND PT HAD SEEN THEM ONE TIME. PT STATED THEY HAVEN'T SEEN THEIR DOCTOR FOR SO LONG. AGENT HAD DIFFICULTY UNDERSTANDING THE PATIENT BECAUSE THEY WERE TALKING TOO FAST. AGENT REVIEWED SENDING THE PHYSICIAN LISTINGS BUT PT ASKED IF THEY COULD GO BACK TO VA. AGENT PROVIDED THE NAS PHONE NUMBER AND REDIRECTED PT TO THEIR HCP TO SET UP AN APPOINTMENT WITH A REP TO FURTHER ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20837 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male