BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 22391113 · Received July 2, 2025

    Report

    Report Number
    3004209178-2025-11338
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Report Date
    July 21, 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
    OH, 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.

    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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THERE WAS NO ALLEGATION ON THE LEAD. THE REP STATED THAT THE PATIENT WAS UNABLE TO INCREASE STIMULATION. THE CAUSE OF THE HIGH IMPEDANCES WAS UNKNOWN. THE PATIENT WAS REPROGRAMMED USING NORMAL IMPEDANCE CONTACTS. THE PATIENT'S HEALTHCARE PROVIDER (HCP) WILL MONITOR AND IF NEEDED, ADD A SECOND LEAD IF THE ISSUE CONTINUES. THE IMPEDANCE ISSUE HAS NOT BEEN RESOLVED AS THEY WILL CONTINUE TO MONITOR IMPEDANCES IN THE FUTURE. THE INFORMATION WAS CONFIRMED WITH THE PHYSICIAN/PATIENT.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT (PT) WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). REP REPORTS THE PATIENT WAS UNABLE TO INCREASE THEIR STIMULATION. HIGH IMPEDANCES WERE OBSERVED: CONTACT 1-32920 CONTACT 4 -34270 CONTACT 5 -32660 CONTACT 6 -32710. REP REPORTS THE CAUSE IS UNKNOWN, AND THEY TROUBLESHOOTED THE ISSUE BY PERFORMING IMPEDANCE CHECKS. REP REPORTS THE ISSUE IS NOT RESOLVED AND IS STILL ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1884068 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female