INTELLIS
Report
- Report Number
- 3004209178-2025-12568
- Event Type
- Injury
- Date Received
- July 23, 2025
- Date of Event
- July 16, 2025
- Report Date
- October 15, 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
- OTHER
- Health Professional
- N
Narratives
CONTINUATION OF D10: PRODUCT ID 977A260 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2023 PRODUCT TYPE LEAD PRODUCT ID 977A260 LOT# SERIAL# (B)(6) IMPLANTED: (B)(6) 2023 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.
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.
G2 UPDATED TO MORE ACCURATELY REPRESENT PREVIOUSLY REPORTED INFORMATION. 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.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). REP CLARIFIED THAT THEY WERE ONLY DESCRIBING POCKET PAIN, AND THAT THE PAIN WAS NOT RELATED TO ANY INS POCKET ISSUES. WHEN REP TALKED ABOUT BAD CONNECTION, THEY WERE REFERENCING THE ELECTRODE CONNECTION TEST IN THE LEAD SELECT SCREEN. ELECTRODES 6 AND 13 HA A RED X INSTEAD OF THE NORMAL GREEN CHECKMARK. THE CAUSE OF THE HIGH IMPEDANCE WAS NOT DETERMINED. REP REPROGRAMMED THE PT ON (B)(6) 2025. THE ISSUE HAS NOT BEEN RESOLVED AND THERE IS A PLAN TO REVISE THE POCKET SITE (DATE UNKNOWN). THE DEVICE REMAINS IN USE AND THE INFORMATION HAS BEEN CONFIRMED WITH THE PHYSICIAN.
INFORMATION WAS RECEIVED FROM A PATIENT (PT) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING THE PT'S IMPLANTABLE NEUROSTIMULATOR (INS). REP REPORTS HIGH IMPEDANCES WERE OBSERVED: "ELECTRODE IMPEDANCE: 5-30870, 6-32000, 13-32200, 14-32660. ALL OTHER ELECTRODES HAVE NORMAL RANGE IMPEDANCE." REP REPORTS TROUBLESHOOTING THIS ISSUE BY PERFORMING A LEAD CONNECTION TEST, AND IMPEDANCE TEST. ELECTRODES 6 AND 13 HAD A BAD CONNECTION. THE CAUSE OF THE HIGH IMPEDANCES WAS UNKNOWN. REP REPORTS THERE WAS AN INS IN POCKET ISSUE DESCRIBED AS THE INS WAS IMPLANTED IN THE BUTTOCK, WHICH HAS BEEN PAINFUL FOR THE PATIENT TO BE SEATED. NO TROUBLESHOOTING WAS PERFORMED FOR THIS. THE ISSUES WERE UNRESOLVED AND A DEVICE REVISION IS PLANNED FOR (B)(6) 2025.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP STATING THE PLAN IS FOR THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET SITE TO BE REVISED LATER THIS MONTH. REP NOTES THAT THIS ISSUE IS STILL ONGOING, BUT IT IS PLANNING TO BE RESOLVED AFTER THE REVISION.
NO NEW INFORMATION.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE ISSUE HAS BEEN RESOLVED. THE POCKET WAS REVISED ON (B)(6) 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57780 | INTELLIS | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97715 | 00763000315467 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Unknown | Required Intervention | "SEE H11...." |