BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 24681696 · Received March 24, 2026

    Report

    Report Number
    3004209178-2026-05270
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    March 2, 2026
    Report Date
    March 24, 2026
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315474
    PMA / PMN Number
    P840001
    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 THE PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) EXPERIENCED AN IMPEDANCE ISSUE AND RECEIVED A "SETTINGS NOT AVAILABLE" MESSAGE ON ALL THREE PROGRAMS AFTER PERFORMING EXTENSIVE YARDWORK WITH A CHAINSAW. IMPEDANCE CHECKS SHOWED OPEN/SHORT VALUES (2: 39130, 10: 33710, 12: 36210, AND WHEN SWITCHING TO REFERENCE ELECTRODE EIGHT, 2: 40000), AND A CONNECTION CHECK INDICATED ALL CONNECTIONS WERE GREEN. ALL PROGRAMMING WAS USING THESE THREE ELECTRODES. THE DEVICE WAS REPROGRAMMED AND REMAINS IN SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742757 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97716 00763000315474

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Male