BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 24718891 · Received March 30, 2026

    Report

    Report Number
    3004209178-2026-05522
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    October 16, 2025
    Report Date
    April 3, 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
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REGULATORY REPORT # 3004209178-2026-05522 INCORRECTLY SUBMITTED WITH INCORRECT DATE OF 2026-JAN-16 IN G3. CORRECTION SENT WITH CORRECT G3 DATE OF 2026-MAR-10 ENTERED. 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

    PATIENT STATED THAT HAVE A NEW HEALTHCARE PROVIDER (HCP) AND THEY REPORTED THAT THEIR PAIN HAS BEEN VERY BAD FOR THE PAST 3 MONTHS. PATIENT SAID THAT THEIR PA ADVISED TO CALL US AND SEE WHAT THEY CAN DO WITH THAT. AGENT REVIEWED INFORMATION AND SENT PROVIDED NAS NUMBER AND EMAILED A MANUFACTURING REPRESENTATIVE (REP). ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). REP REACHED OUT TO THE PATIENT (PT) TO SCHEDULE APPOINTMENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT (PT). PT SAID THE PAIN HAD INCREASED OVER THE PAST YEAR. PT SAID THERE WAS A NOTICEABLE PAIN INCREASE AFTER A SPINAL ABLATION ON (B)(6) 2025. PT SAID PAIN MANAGEMENT SUGGESTED THEY CONTACT MANUFACTURER. PT HAD TWO ADJUSTMENTS SINCE JAN 16 WHICH HAD NOT BEEN ABLE TO NEGATE PAIN. PT SAID THEIR DOCTOR REQUESTED AN UPGRADE IN THE PT'S EQUIPMENT. ISSUE NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781168 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female