INTELLIS
Report
- Report Number
- 3004209178-2025-21548
- Event Type
- Injury
- Date Received
- December 22, 2025
- Report Date
- January 13, 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
B3: EVENT DATE IS NOT KNOWN. PLEASE SEE B5 FOR APPROXIMATE DATE RANGE, IF APPLICABLE. SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME SPECIFY SURESCAN; PRODUCT ID 977C265 (SERIAL: (B)(6)); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2023; EXPLANT DATE (B)(6) 2025. 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) 2023, 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.
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT (PT) WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). REP REPORTS THE LEAD WAS EXPLANTED. REGISTRATION SHOWS THE LEAD WAS REPLACED. NO SYMPTOMS WERE REPORTED.
ADDITIONAL INFORMATION FROM THE REP INDICATED THAT THEY BECAME AWARE OF THIS ON THE SAME DAY AS THE CASE. THEY INDICATED THAT THERE WAS A LEAD ISSUE, AS THERE WERE ORANGE IMPEDANCES ON ELECTRODES 3 (28370), 4(28060), 7(28270), 9(26650), 10(28570), 11(28820), 12(27860), 14(28060), AND 15(28370). IT IS UNKNOWN WHEN THE ISSUE FIRST STARTED. THE FIRST DOCUMENTATION IN MFORCE WAS (B)(6) 2025.THE REP NOTED THAT THE ORIGINAL LEAD WAS TESTED WITH WENS, CONFIRMED LEAD WAS THE ISSUE AND LEAD WAS REPLACED. THE LEAD WAS DISCARDED AND WILL NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 255834 | INTELLIS | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97715 | 00763000315467 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Required Intervention | "SEE H11...."| SEE H11... |