BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 24387401 · Received February 19, 2026

    Report

    Report Number
    3004209178-2026-02747
    Event Type
    Injury
    Date Received
    February 19, 2026
    Report Date
    May 21, 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
    MN, 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

    IT WAS REPORTED THAT HIGH IMPEDANCE WAS OBSERVED WITH THE IMPLANTABLE NEUROSTIMULATOR 97715 INTELLIS ADAPTIVESTIM PAIN AND TWO LEAD 977A260 5MM COMPACT 1X8 MAGNETIC RESONANCE IMAGING (MRI) DEVICES, ALL OF WHICH REMAIN IMPLANTED AND IN SERVICE. IMPEDANCE VALUES WERE REPORTED AS FOLLOWS: CONTACT 8 - 22630, CONTACT 9 - 13300, CONTACT 10 - 13700, CONTACT 12 - 19480, CONTACT 13 - 21190, AND CONTACT 15 - 18870. THE HIGH IMPEDANCE WAS NOT OBSERVED ON THE DAY OF SURGERY AND NO OTHER STIMULATION ISSUES WERE REPORTED. IMPEDANCE CHECKS WERE PERFORMED AS TROUBLESHOOTING. THE ISSUE IS ONGOING AND HAS NOT BEEN RESOLVED. THE PATIENT IS SCHEDULED FOR IMPLANTABLE NEUROSTIMULATOR AND LEAD REPLACEMENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE MANUFACTURER REPRESENTATIVE (REP) INDICATED THEY WOULD SEND ANY FURTHER INFORMATION AS THEY BECOME AWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384600 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1