INTELLIS
Report
- Report Number
- 3004209178-2025-02177
- Event Type
- Malfunction
- Date Received
- February 6, 2025
- Date of Event
- October 29, 2024
- Report Date
- April 2, 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
- FL, 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. 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.
IT WAS REPORTED THAT A PATIENT WITH A PAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED ISSUES WITH THE DEVICE SETTINGS. THE PATIENT WAS UNABLE TO ACCESS CERTAIN SETTINGS, ADJUST THE INTENSITY, OR FEEL THE USUAL STIMULATION. ADDITIONALLY, ATTEMPTS TO SWITCH GROUPS DID NOT ALLOW FOR ADJUSTMENTS TO THE STIMULATION; INSTEAD, THE STIMULATION WOULD CUT OUT AND NO CHANGES OCCURRED. THE AGENT REVIEWED THE ERROR MESSAGE AND ADVISED THE PATIENT TO CONTACT A REPRESENTATIVE FOR FURTHER ASSISTANCE. THE ISSUE WAS NOT RESOLVED. REP REPORTED THAT PATIENT IN THE CLINIC AND REPORTS THE PATIENT IS SEEING AN ERROR MESSAGE STATING THAT IT CANNOT PROVIDE DESIRED SETTINGS. THE PATIENT IS PROGRAMMED ON ELECTRODES 10, 12, 13, AND 14. REP REPORTS THE FOLLOWING IMPEDANCES: REFERENCE OF 0: 11 IS AT 31,000 OHMS AND 14 IS AT 30,540 OHMS. REFERENCE OF 10: 12: 1230 OHMS 13: 1300 OHMS REFERENCE OF 12: 10: 1230 OHMS 13: 1190 OHMS TS REVIEWED PROGRAMMING AROUND ELECTRODE 14, OR ANY ELECTRODE PAIRS THAT SHOW HIGH IMPEDANCES.
PT REPORTED THAT SOME OF THE ELECTRODES HAD TO BE CHANGED AND REPROGRAMMED. PATIENT RECEIVED A NEW REMOTE AND THE SETTINGS WERE RESET. THE ISSUE HAS BEEN RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 919913 | INTELLIS | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97715 | 00763000315467 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Unknown |