INTELLIS
Report
- Report Number
- 3004209178-2024-22758
- Event Type
- Malfunction
- Date Received
- November 27, 2024
- Report Date
- December 23, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00643169781702
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, 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.
REP REPORTED THAT WHEN THEY FIRST MET THE PATIENT ON (B)(6) 4, THERE WERE NO DEVICE OR IMPEDANCE ISSUES. THE PATIENT ASKED TO HAVE ADAPTIVSTIM TURNED ON, SO WE PROGRAMMED IT. THERE WERE A FEW POSITIONS THAT THEY DID NOT ORIENT/PROGRAM, SUCH AS LAYING PRONE, AND REP EDUCATED THE PATIENT ON HOW TO SET THE INTENSITY OF THOSE POSITIONS WHEN HE WAS READY. WITHIN A MONTH, THE PATIENT WAS NOT HAPPY WITH ADAPTIVSTIM AND REP INSTRUCTED HIM TO TURN IT OFF. THE PATIENT TEXT MESSAGED REP ON (B)(6) 2024 ASKING TO MEET THIS WEEK AND SCHEDULED A TIME FOR (B)(6). DURING THE INTERROGATION ON (B)(6) 2024, THE BATTERY SHOWED THREE IMPEDANCE ISSUES, WITH ELECTRODES 0, 8, AND 12. IT ALSO SHOWED THAT HIS BATTERY HAD BEEN DEPLETED ONCE. THE PATIENT NEVER TURNED ADAPTIVSTIM OFF EITHER. AFTER DISCUSSING HIS CURRENT PAIN PATTERN, REP TRIED MULTIPLE ELECTRODE CONFIGURATIONS, PWS, AND RATES TO TRY TO CAPTURE HIS LOW BACK PAIN, BUT REP WAS UNSUCCESSFUL. PATIENT'S FINAL PROGRAMMING ON 12/03 WAS AN LD WAVEFORM, SIMILAR TO WHAT HE HAD PRIOR TO (B)(6) 2024, BUT PROGRAMMING AROUND ELECTRODES 0, 8, AND 12. REP AGAIN SUGGESTED THAT HE REACH OUT TO HIS PAIN/IMPLANTING HCP FOR FURTHER GUIDANCE. REP BELIEVED THAT THIS IS AN EDUCATIONAL ISSUE.
ON (B)(6)2024: INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS THE PT HAD BEEN GOING AROUND AND ROUND WITH A MANUFACTURER REPRESENTATIVE (REP) GETTING THEIR INS REPROGRAMMED SINCE THE INS WAS NOT REMEMBERING ALL THE SETTINGS, THEY WERE SETTING THE INTENSITY TO. THE LAST PERSON THEY SPOKE TO SAID TO CALL FOR A NEW CONTROLLER SINCE THE ISSUE WAS WITH THE CONTROLLER AND NOT THE INS. THE REP SAID THE CONTROLLER WAS BAD DUE TO PROGRAMMING ISSUES. THIS MORNING WAS AN EXAMPLE WHERE THEY WERE ON GROUP A AND IT MEASURED ALL THE INTENSITY LEVELS AT 0, LAST NIGHT THEY HAD ONE SET TO 3.5 AND THE OTHERS AT 2.8 WHICH WAS CLOSE TO WHAT IT WAS SUPPOSED TO BE SET. PT NOTED THEY COULD NOT SCREW WITH IT EVERY DAY BECAUSE THE PTS PROGRAMMING COULD NOT REMEMBER THE SETTINGS MOST OF THE TIME THAT IT SHOULD BE WITH. PT HAD ALREADY WORKED WITH DIFFERENT PEOPLE AND WAS FEELING LOST SINCE THERE WAS NOBODY TO GET THINGS DONE. THE PT SAID THEY THOUGHT THEY BECAME REALLY AWARE OF IT AFTER A REP CAME OUT TO SEE THEM. THE DEVICE HAD BEEN TAKEN OUT OF ADAPTIVE STIM BY A REP AND IT WAS WORKING FINE THEN IT WAS NOT WORKING, THE REP TURNED THE ADAPTIVE STIM BACK ON AND IT WENT TO CRAP. PT SAID WHEN THEY CHANGED THE DEVICE BY PUTTING THEIR THERAPY IN ADAPTIVE STIM PROGRAMMING; THAT WAS WHEN IT ALL STARTED. THE DAY AFTER PROGRAMMING THE PT HAD TO TURN THERAPY UP ON GROUP A TO GET RELIEF AND LATER THEY TURNED DOWN WHEN THEY WERE SETTLED, THEN WHEN THEY TRIED GROUP B OR C ON THAT SATURDAY ALL THE VALUES WERE AT 0 INTENSITY FOR THE INS PROGRAMMING FORGOT EVERYTHING EXCEPT GROUP A. PT SAID IT WAS NOT WORKING. THE REP SAID THE PT MIGHT HAVE A LOW BATTERY OR THIS OR THAT BUT IT WAS NOT A INS ISSUE. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. 2024-NOV-26: ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT A MANUFACTURER REPR ESENTATIVE (REP) MET WITH THE PATIENT BECAUSE THEY REQUESTED A REPROGRAMMING. PATIENT STATED THAT THEIR PAIN WAS NOT BEING COVERED AND THEY WANTED ADAPTIVSTIM TURNED ON. THEY WENT THROUGH THE ENTIRE SETUP. A FEW DAYS LATER PATIENT REACHED OUT TO TELL THE REP THAT ONE OF THEIR PROGRAMS SHOWED ALL ¿0¿S FOR INTENSITIES. REP SHARED ALL OF THEIR INTENSITY PROGRAMMING WITH THE PATIENT AND REMINDED THEM TO STAY IN THAT SPECIFIC POSITION AFTER CHANGING THE VALUE SO THAT IT WOULD BE SET. PATIENT THEN REACHED OUT AGAIN STATING THAT THEY ARE STILL NOT HAVING GOOD COVERAGE. AN APPOINTMENT HAD TO BE RESCHEDULED. REP ALSO SUGGESTED THAT THEY REACH OUT TO THEIR PAIN DOCTOR/SURGEON/ETC FOR ADDITIONAL QUESTIONS AND CONCERNS ABOUT STIMULATION COVERAGE AS THE REP TRIED EVERY CONFIGURATION POSSIBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2434866 | INTELLIS | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97715 | 00643169781702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |