BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 22629759 · Received July 28, 2025

    Report

    Report Number
    3004209178-2025-12767
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Report Date
    July 28, 2025
    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
    MI, 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 IMPLANTED INTELLIS ADAPTIVESTIM PAIN IMPLANTABLE NEUROSTIMULATOR AND TWO LEAD 977A260 5MM COMPACT 1X8 MAGNETIC RESONANCE IMAGING (MRI) LEADS EXPERIENCED HIGH IMPEDANCE, LOSS OF STIMULATION, AND "OUT OF REGULATION" OR UNAVAILABLE SETTINGS. DURING A CONNECTIVITY CHECK, ELECTRODES 12-15 WERE FOUND NOT CONNECTED. IMPEDANCE CHECKS USING ELECTRODE 0 AS THE REFERENCE POINT SHOWED VALUES OF 12- 840, 13- 40,000, 14- 40,000, AND 15- 40,000; USING ELECTRODE 8 AS THE REFERENCE POINT, VALUES WERE 12- 1050, 13- 40,000, 14- 40,000, AND 15- 1750. THE PATIENT DENIED ANY FALLS OR TRAUMAS BUT REPORTED EXCESSIVE BENDING AND TWISTING WHILE GARDENING THROUGHOUT THE SUMMER. TROUBLESHOOTING INCLUDED REPROGRAMMING THE DEVICE TOUTILIZE USABLE ELECTRODES AND CONFIRMING STIMULATION COULD BE ADJUSTED. THE ISSUE IS ONGOING AND RELATED TO DEVICE FUNCTION. 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
    1507716 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female