INTELLIS
Report
- Report Number
- 3004209178-2024-22452
- Event Type
- Malfunction
- Date Received
- November 21, 2024
- Date of Event
- October 9, 2024
- Report Date
- January 21, 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
- KS, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
B3: DATE IS APPROXIMATE. YEAR IS CONFIRMED VALID. CONTINUATION OF D10: PRODUCT ID 377760 (LOT: N0030655); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE ; EXPLANT DATE PRODUCT ID 377760 (LOT: V013515); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE ; EXPLANT DATE. 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.
INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR, SPECIFICALLY THE MEDTRONIC INTELLIS ADAPTIVESTIM PAIN DEVICE, WAS NOT ALLEVIATING THE PATIENT'S BACK PAIN. THE PATIENT EXPERIENCED A RETURN OF PAIN AND WAS UNABLE TO ACTIVATE THE STIMULATION, AS THE DEVICE'S CONTROLLER INDICATED THAT THE STIMULATION WAS OFF. ADDITIONALLY, WHEN ATTEMPTING TO INCREASE THE INTENSITY, THE SETTINGS WERE NOT AVAILABLE. THE PATIENT CONFIRMED THAT THEY HAD NOT EXPERIENCED ANY RECENT FALLS OR TRAUMAS. TROUBLESHOOTING EFFORTS DID NOT RESOLVE THE ISSUE, AND THE PATIENT WAS ADVISED TO CONSULT THEIR HEALTHCARE PROVIDER FOR FURTHER ASSISTANCE. FURTHER INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE ELECTRODES WERE OUT OF RANGE. THE ISSUE WAS EVENTUALLY RESOLVED.
ADDITIONAL INFORMATION FROM THE REP INDICATED THAT NOW ONLY ELECTRODES 5, 8, 9, AND 12 ARE FUNCTIONAL. REPROGRAMMING WAS DONE USING ONLY THOSE ELECTRODES.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT TO RESOLVE THE ISSUE THEY REPROGRAMMED AROUND THE HIGH IMPEDANCE ELECTRODES. THE CAUSE WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2257538 | INTELLIS | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97715 | 00763000315467 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Male |