INTELLIS
Report
- Report Number
- 3004209178-2025-13638
- Event Type
- Injury
- Date Received
- August 12, 2025
- Date of Event
- January 1, 2025
- Report Date
- February 27, 2026
- 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
- MN, US
- Reporter Occupation
- 003
Narratives
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.
B3: DATE IS APPROXIMATE. YEAR IS CONFIRMED VALID. 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.
H3: PRODUCT: 97715, S/N:(B)(6) WAS RETURNED FOR ANALYSIS. THE RETURNED DEVICE WAS SUBJECTED TO A SERIES OF STANDARD TESTS THAT INCLUDE BUT IS NOT LIMITED TO VISUAL INSPECTION, OUTPUT AND TELEMETRY TESTING, AND FUNCTIONAL TESTING. THE IMPLANTABLE NEUROSTIMULATOR (INS) PASSED FUNCTIONAL TESTING. PRODUCT: 977C265, S/N: (B)(6) WAS RETURNED FOR ANALYSIS. THE RETURNED DEVICE WAS SUBJECTED TO A SERIES OF STANDARD TESTS THAT INCLUDE BUT IS NOT LIMITED TO VISUAL INSPECTION AND ELECTRICAL TESTING. ANALYSIS IDENTIFIED THAT A WELD WAS CORRODED AT THE DISTAL END OF THE LEAD. ANALYSIS IDENTIFIED THAT THE OUTER INSULATION ON THE LEAD WAS CUT. 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.
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.
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.
CONTINUATION OF D10: PRODUCT ID 977C265, SERIAL# (B)(6), IMPLANTED: (B)(6) 2022, EXPLANTED: (B)(6) 2025, PRODUCT TYPE: LEAD. 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 INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE FOLLOWING ARE THE IMPEDANCE VALUES: 0 REFERENCE 8 36140, 1 20380, 9 35850, 2 28840, 10 34210, 3 19160, 11 32560, 4 39330, 12 40000, 5 39970, 13 40000, 6 39280, 15 34900, 7 40000. THE PATIENT SAID SHE FELL IN (B)(6) 2023 WHICH LED TO SEVERAL ANKLE SURGERIES. THE PATIENT WILL BE REFERRED TO DR. (B)(6) TO DISCUSS LEAD REPLACEMENT. THE ISSUE WAS NOT RESOLVED. THEY TRIED REPROGRAMMING BUT NO STIMULATION WAS PERCEIVED BY THE PATIENT AFTER SEVERAL PROGRAMMING ATTEMPTS. THE INFORMATION WAS CONFIRMED BY THE PHYSICIAN.
INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS TO REPORT THE EVENT. THE CALLER INDICATED THAT THE PATIENT HAS BEEN GETTING THE MESSAGE CANNOT DELIVER DESIRED SETTINGS ON THE PATIENT CONTROLLER SINCE (B)(6) 2025. THE CALLER MEASURED IMPEDANCES AND ALL ELECTRODE HAVE THE ORANGE INDICATOR. THE CALLER TRIED PROGRAMMING DIFFERENT ELECTRODE CONFIGURATIONS AND WAS UNABLE TO GET STIMULATION PERCEPTION. TROUBLESHOOTING WAS NOT REQUIRED. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING.
ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE (REP) WHO REPORTED NO LEAD REPLACEMENT WILL TAKE PLACE AS THE PATIENT IS NOW GETTING STIMULATION WHERE THEY NEED. REP REPORTED THEY REPROGRAMMED OFF THE ELECTRODES AND STIMULATION IN THE AREA NEEDED WAS ACHIEVED.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE LEAD WAS BROKEN. IT WAS REPORTED THAT THE REP REITERATED THE LOSS OF STIMULATION AND LOSS OF COVERAGE ON THE RIGHT SIDE. LEAD REVISION DUE TO LOST COVERAGE AND DURING THE PROCEDURE IT WAS NOTED THE LEAD BODY WAS FRACTURED. THE ISSUE WAS RESOLVED. 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 |
|---|---|---|---|---|---|---|---|
| 2413393 | INTELLIS | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97715 | 00763000315467 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Female | Required Intervention | "SEE H11...." |