INCEPTIV
Report
- Report Number
- 3004209178-2026-04320
- Event Type
- Malfunction
- Date Received
- March 10, 2026
- Date of Event
- March 9, 2026
- Report Date
- March 27, 2026
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00763000984687
- 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. 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. 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). IT WAS REPORTED THAT THE REP REITERATED THE INABILITY TO FEEL STIMULATION. PATIENT THOUGHT MAYBE THEY SLIGHTLY FELT STIMULATION IN THEIR ARM OR WHEN THEY TURNED THEIR HEAD HERE OR THERE, BUT THAT SENSATION DID NOT LAST. PATIENT WAS PROGRAMMED ON PROGRAMS 0-3 AND 0-2, BUT NONE OF THE PROGRAMS SEEMED TO BE WORKING FOR THE PATIENT. PATIENT TRIED 5 PROGRAMS, BUT NONE OF THEM WORKED. IMPEDANCE CHECK SHOWED GOOD IMPEDANCES 0, 1, AND 2, ELECTRODES 3, 4, 5, AND 6 WERE "ORANGE" AND 7 IS DO NOT USE. AGENT SUGGESTED THE REP TRY DIFFERENT PROGRAMMING OPTIONS.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) STATING THE IMPEDANCE CONTACTS 0: 2069, 1- UNKNOWN USED FOR REFERENCE, 2: 3469, 3: 18,981, 4: 19,377, 5:18066, 6 AND 7 CONNECTIVITY ISSUES. CAUSE WAS NOT DETERMINED. THIS ISSUE HAS NOT BEEN RESOLVED.
INFORMATION WAS RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE (REP) REGARDING A PATIENT (PT) WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS REP REPORTS THE PT IS IN RECOVERY AND THE PT HAS A LEAD THAT REP BELIEVE IS PROPERLY PROGRAMMED. REP REPORTS 0,1 AND 2 OF THE CONTACTS ARE ALL GREEN, 3, 4, 5 ARE AVOID, 6, AND 7 HAVE CONNECTIVITY ISSUES. WITH REFERENCE OF 2, THE PATIENT IS GETTING 3578 OHMS ON CONTACT 0 AND 3580 ON 1. THEY ARE NOT ABLE TO GET PERCEPTION ON ANY OF THOSE USABLE CONTACTS. REP HAS TURNED THE STIMULATOR UP AMPLITUDES TOWARD 20 MA AND CHANGED THE REFERENCE ELECTRODES WHEN COMPLETING AN IMPEDANCE CHECK, BUT THAT DID NOT RESOLVE THE ISSUE. REP ALSO REPORTS THE PATIENT IS NOT FEELING ANYTHING FROM ANY OF THE CONTACTS THEY ARE PROGRAMMED ON. THEY HAVE LAID THE PATIENT DOWN, HAD THE PATIENT MOVE THEIR HEAD SIDE TO SIDE, WIDENED THE PULSE WIDTH, AND LOWERED THE PULSE, BUT PATIENT IS STILL NOT FEELING STIMULATION. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 621892 | INCEPTIV | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 977119 | 00763000984687 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Female |