BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 23450226 · Received November 3, 2025

    Report

    Report Number
    3004209178-2025-18655
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Report Date
    November 3, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315467
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS NOT KNOWN. PLEASE SEE B5 FOR APPROXIMATE DATE RANGE, IF APPLICABLE. 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 MULTIPLE SOURCES REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR (INS). HIGH IMPEDANCES WERE REPO RTED. ELECTRODE 7: 32720 ELECTRODE 12: 33090.  THE CAUSE WAS UNKNOWN. THESE HIGH IMPEDANCES WERE FOUND DURING A PATIENT REPROGRAMMING MEETING. PATIENT HAD NOT REPORTED ISSUES WITH STIMULATOR RELATED TO THESE HIGH IMPEDANCES. NO SYMPTOMS WERE REPORTED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886900 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female