BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIS

    MDR report key: 19629444 · Received June 27, 2024

    Report

    Report Number
    3004209178-2024-13746
    Event Type
    Injury
    Date Received
    June 27, 2024
    Report Date
    October 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
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A260, SERIAL/LOT #: (B)(6), UBD: 13-JUN-2025, UDI#: (B)(4); PRODUCT ID: 977A260, SERIAL/LOT #: (B)(6), UBD: 13-JUN-2025, UDI#: (B)(4). 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. 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

    2023-03-14: INFORMATION WAS RECEIVED REGARDING A PATIENT THAT WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT HAS HIGH IMPEDANCES. ELECTRODE 7 WAS 24240 OHMS AND ELECTRODE 8 WAS 4310 OHMS. PATIENT HAD A FALL BACK IN DECEMBER AND BELIEVES THIS MAY HAVE CAUSED SOME CHANGES IN HER LEADS. THE PATIENT'S PROGRAMMING WAS MOVED TO ANOTHER ELECTRODE. THERE HAVE BEEN NO ISSUES AFTER REPROGRAMMING. THE ISSUE WAS RESOLVED. NO SYMPTOMS WERE REPORTED. 2023-APR-14: ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. PATIENT HAD A MEETING TO BE REPROGRAMMED AND REP NOTICED SHE HAD ANOTHER ELECTRODE SHOWING HIGH IMPEDANCE. NO RECENT FALL WAS DETECTED. THE REP WAS ABLE TO PROGRAM AROUND IT BUT THE OFFICE STAFF AND DOCTOR WERE NOTIFIED. 2023-DEC-21: ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THEY ENCOUNTERED HIGH IMPEDANCES; 1- 4430, 2- 25620, 3- 19850, 6- 25620, 7- 25680, 8-18400, 10- 25680, 11- 19400, 12- 25620, AND 15- 25620. PATIENT HAD A LOSS OF STIMULATION AND RETURN OF PAIN. CONNECTIVITY AND IMPEDANCES WERE COMPLETED UPON MEETING THE PATIENT. PATIENT DENIES ANY FALLS OR TRAUMA; HOWEVER, REPORTS THAT SHE RECEIVED A MESSAGE REPORTING "STIMULATION UNAVAILABLE". PATIENT WAS REPROGRAMMED. CAUSE IS NOT KNOWN, AND ISSUE IS ONGOING. 2024-MAY-10: ADDITIONAL INFORMATION WAS RECEIVED FROM A PATIENT. THE REASON FOR CALL WAS PATIENT STATED THAT THEIR SETTINGS ARE NOT WORKING AND THEY NEED TO MEET WITH SOMEONE TO ADJUST THE SETTINGS. ISSUE STARTED ON SATURDAY AND THEIR BACK WAS GETTING WORSE. AGENT ASKED IF PT TRIED TO ADJUST THERAPY AND PATIENT STATED THEY DID BUT THAT THE MACHINE WILL NOT PROVIDE THE DESIRED INTENSITY. PT HAD THIS HAPPEN 3 OR 4 TIMES BEFORE AND THEY WOULD MEET WITH A REP WHO WOULD RESOLVE THAT ISSUE BUT NOW THE PATIENT LOST THEIR CONTACT INFO. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. AGENT SENT A MESSAGE TO LOCAL REPS. 2024-MAY-28: ADDITIONAL INFORMATION WAS RECEIVED FROM A REP. THE REP REPORTED THAT THEY HAD REPROGRAMMED THE PATIENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT NOW IMPEDANCES ARE AT 0-40,000 2,6,7,9,10 ,12-27000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852062 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention "SEE H11...."