BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 23646117 · Received November 25, 2025

    Report

    Report Number
    2182207-2025-03251
    Event Type
    Injury
    Date Received
    November 25, 2025
    Report Date
    November 25, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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

    (B)(6) 2024 OBTAINED LEFT LOWER EXTREMITY FRACTURE CONFIRMED BY XRAY. ORTHOPEDIC SURGEON INDICATED NO SURGICAL INTERVENTION NEEDED. PLACED ON 6 WEEK HOLD FROM STAND AND STEP INTERVENTIONS WITH WEIGHT BEARING RESTRICTIONS. (B)(6) 2024 PARTICIPANT CLEARED BY ORTHOPEDICS TO RESUME STAND TRAINING AND STEP TRAINING ON (B)(6) 2024. FRACTURE RESOLVED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947647 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION 97715

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Unknown Other