INTELLIS
Report
- Report Number
- 3004209178-2025-03601
- Event Type
- Malfunction
- Date Received
- February 26, 2025
- Date of Event
- February 25, 2025
- Report Date
- April 7, 2025
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
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.
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: THE COUNTRY OF THE EVENT IS CH. 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. TECHNICAL SERVICES REPORTED THAT THE ERROR DESCRIBED IS NOT COMMON AND SEEMS TO ARISE WHEN THERE IS A SPECIFIC COMBINATION OF SEVERAL FACTORS. TECHNICAL SERVICES WAS ABLE TO REPRODUCE THE ISSUE ON TWO OCCURRENCES. THEY NOTED THAT "TO HAVE A VALID ORIENTATION, YOU NEED AT LEAST THREE POSITIONS ASSIGNED (UPRIGHT, LYING BACK OR FRONT AND LYING LEFT OR RIGHT). I DIDN¿T CHANGE THE INS POSITION WHEN I DID THE ORIENTATION. THIS RESULTED IN FIRST THE POSITION OVERLAP FOR LEFT/RIGHT AND THEN THE INVALID ORIENTATION MESSAGE. IT THEN BEGAN THE ORIENTATION FROM THE START. I DIDN¿T CHANGE THE INS POSITION FOR LYING BACK AND FRONT, I DID FOR THE OTHER POSITIONS. AT THE END OF THE ORIENTATION, IT SHOWED ME THE INVALID ORIENTATION MESSAGE AND BEGAN THE ORIENTATION FROM THE START. THEREFORE, THE MOST PLAUSIBLE REASON FOR NOT BEING ABLE TO PROGRAM THE ADAPTIVESTIM IS THAT THERE IS TOO MUCH OVERLAP BETWEEN THE POSITIONS. THE INS DETECTS THAT THE LYING RIGHT/LEFT POSITIONS, OR THE LYING BACK/FRONT WITH THE LYING LEFT/RIGHT, ARE VERY SIMILAR AND INDICATES THIS VIA THE INVALID ORIENTATION MESSAGE." TECHNICAL SERVICES ADVISED TO "TRY POSITIONING THE PATIENT AGAIN AND ENSURING THERE IS A LARGE ENOUGH DISTINCTION BETWEEN POSITIONS. CHANGE THE ANGLES IF NEEDED. IT MAY HELP TO SKIP EITHER LYING LEFT OR RIGHT AND SKIP EITHER LYING FRONT OR BACK SO THEY ONLY USE THREE POSITIONS TO ORIENT. THE INS ONLY REQUIRES THREE POSITIONS TO SUCCESSFULLY ORIENT; UPRIGHT, LYING LEFT OR RIGHT, AND LYING FRONT OR BACK. IF THEY ORIENT USING ONLY THREE POSITIONS (E.G. UPRIGHT, FRONT AND LEFT) THE STIMULATOR WILL STILL BE ABLE TO RECOGNIZE ALL POSITIONS. IF THE ABOVE STEPS DON¿T WORK, YOU COULD ALSO TRY AND PROGRAM ADAPTIVESTIM WITH ORIENTING ONLY. SET THE POSITIONS FOR THE PATIENT AND LEAVE THE INTENSITY AT 0.0 MA, SUBSEQUENTLY ON THE FINAL ADAPTIVESTIM SCREEN YOU CAN SET THE INTENSITIES INDIVIDUALLY PER POSITION." ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE INS WAS IMPLANTED IN THE LEFT ABDOMEN. THIS WAS FROM A FIRST IMPLANT IN 2020. THE REP COULDN'T PROGRAM A SINGLE SIDE, THEY STARTED WITH THE LEFT SIDE AND THE MESSAGE APPEARED, THEY TRIED TO START WITH THE RIGHT SIDE, BUT GOT THE SAME THING, THE MESSAGE APPEARED. THEY DID NOT GET A NOTIFICATION, ONLY THE MESSAGE IN THE PHOTO THEY SENT. THE REP WAS NEVER ABLE TO ACCESS THE OTHER POSITIONS, THEY COULD ONLY ENTER STANDING AND LYING AND AS SOON AS THEY WANTED TO PROGRAM A SIDE THE MESSAGE APPEARED AND THEY HAD TO START ALL OVER AGAIN, THEY COULDN'T SKIP THE STEPS. THEY CAN'T ACCESS THE CORNERS OR THE END OF THE ADPATIVESTIM PROGRAMMING. AS SOON AS THE MESSAGE APPEARS THEY HAVE TO START AGAIN EACH TIME. WHEN THEY WERE TRYING TO PROGRAM, THEY CHECKED THE PATIENT'S POSITION AND HE'S REALLY WELL ORIENTED, BOTH TO THE RIGHT AND TO THE LEFT. THERE'S NO POSSIBLE ERROR IN THE POSITION, HE'S REALLY LATERAL. THEY REP CAN'T SKIP THESE POSITIONS AND EVERY TIME THEY TRY TO PASS THE SIDES, THE MESSAGE APPEARS. WHEN THEY TRY TO PROGRAM ADAPTIVESTIM AGAIN, THEY DON'T GET THE REORIENTATE TICK, WHICH IS VERY STRANGE. THE REP NOTED THAT THEY DON'T REALLY KNOW WHAT TO DO. TECHNICAL SERVICES NOTED THAT IN SOME CASES, ESPECIALLY WHEN ADAPTIVESTIM WAS LAUNCHED, IT WAS NOTED THAT, DEPENDING ON THE AMOUNT OF FATTY TISSUE AND THE POSITION IN WHICH THE BATTERY WAS ATTACHED, THE ADAPTIVESTIM ON THE INS IMPLANTED IN THE ABDOMEN COULD DETECT VISCERAL MOVEMENTS, OR SOMETIMES THOSE DUE TO BREATHING. THIS COULD EXPLAIN THE APPEARANCE OF THE INVALID ORIENTATION MESSAGE WITHOUT THE PATIENT HAVING MOVED POSITION. IT WAS NOTED THAT THEY CANNOT EXCLUDE THE POSSIBILITY THAT, DUE TO THE IMPLANT LOCATED IN THE ABDOMEN, THE ADAPTIVESTIM POSITIONS ITSELF IN SUPINE MODE WHEN THE PATIENT IS ON HIS SIDE (SUPINE LEFT OR RIGHT). ON A MORE TECHNICAL NOTE, IN THE SOFTWARE APPLICATION, THE MESSAGE "INVALID ORIENTATION" IS DISPLAYED IF THE FOLLOWING CONDITION IS MET: THE APPLICATION CALCULATES THE PRODUCTS OF THE FOLLOWING POSITION COMBINATIONS: "1. RIGHT LYING X PRONE 2. PRONE X LEFT LYING 3. LEFT LYING X BACK LYING 4. BACK LYING X RIGHT LYING". IF AT LEAST ONE OF THE MENTIONED COMBINATIONS RESULTS IN AN OVERLAP (THE SYSTEM DETECTS NO DIFFERENCE BETWEEN THE TWO POSITIONS), THE ORIENTATION IS CONSIDERED INVALID. IT MAY BE BENEFICIAL, IF POSSIBLE, FOR THE PATIENT TO HOLD THEIR BREATH SLIGHTLY OR BREATHE MORE SHALLOWLY WHEN SETTING UP THE ADAPTIVESTIM FOR CERTAIN POSITIONS. THIS MAY HELP TO MINIMIZE POTENTIAL MOVEMENTS AFFECTING THE INS. PATIENT PHYSIOGNOMY, AS WELL AS THE OVERALL CONFIGURATION OF THE IMPLANTED SYSTEM, OFTEN DET ERMINES SO MUCH VARIANCE THAT THE RESOLUTION OF THE SAME PROBLEM COULD BE DIFFERENT BETWEEN PATIENTS.
ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE ADAPTIVESTIM PROGRAMMING ISSUE WAS NOT DETERMINED. THE INFORMATION PROVIDED BY THE TECHNICAL DEPARTMENT HAS BEEN PASSED ON TO THE DOCTOR, WHO HAS CONTACTED THE PATIENT, WHO FOR THE TIME BEING DOES NOT WISH TO MAKE AN APPOINTMENT TO TRY OUT THE RECOMMENDATIONS. THE ISSUE HAS NOT RESOLVED, IT MAY BE AT THE NEXT CONTROL APPOINTMENT. INFORMATION CONFIRMED WITH THE PHYSICIAN / ACCOUNT.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP REPORTING THAT THEY SAW THE PATIENT ON (B)(6) 2025. THE CAUSE WAS THE PATIENT HAS A BELLY AND THE INS WAS NOT PROPERLY ALIGNED. BY PUTTING ON THE CHARGING BELT TO HOLD THE INS IN PLACE, THE REP WAS ABLE TO PROGRAM THE ADAPTIVESTIM (AS). ISSUE WAS RESOLVED. ALL POSITIONS CONTROLLED BY THE REMOTE CONTROL AND AS OPERATED NORMAL.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THEY HAD NO INFORMATION ON THE CAUSE OF THE ADAPTIVESTIM PROGRAMMING ISSUE WITH THE INVALID ORIENTATION MESSAGE. FOR ACTIONS/INTERVENTIONS, THEY PUT ONE GROUP FOR THE DAY IN A STANDING POSITION WITH A PRE-REGULATED INTENSITY AND ANOTHER GROUP IN A LYING POSITION WITH A REDUCED INTENSITY. THE ISSUE HAS NOT BEEN RESOLVED. THEY ARE WAITING TO HEAR BACK FROM THE TECHNICAL DEPARTMENT AFTER ANALYZING THE MEDTRONIC DATA REPORT TO SEE WHAT ACTION NEEDS TO BE TAKEN. THE INFORMATION HAS BEEN CONFIRMED / PROVIDED BY THE PHYSICIAN.
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLAN TED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT DURING THE PROGRAMMING OF THE ADAPTIVESTIM ON GROUP C, AS SOON AS THE DOCTOR TRIED TO PROGRAM THE INTENSITY FOR THE SIDE-LYING POSITION, AN ERROR MESSAGE APPEARED STATING 'INVALID ORIENTATION, ALL POSITIONS MUST BE REORIENTED DUE TO INVALID ORIENTATION.' THERE WAS NO POSSIBILITY OF PROGRAMMING INTENSITIES ACCORDING TO POSITIONS, AND THE ADAPTIVESTIM RESETS TO THE BEGINNING; EIGHT UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE. THERE WERE NO KNOWN ENVIRONMENTAL, EXTERNAL, AND PATIENT FACTORS THAT MAY HAVE CAUSED THE EVENT. TROUBLESHOOTING STEPS INCLUDED CHECKING THE STIMULATOR POSITION, WHICH WAS CONFIRMED TO BE OK AND WELL POSITIONED, CHECKING THE TABLET WHICH WAS NOTED AS "UPDATE OK", AND ATTEMPTING TO PASS CERTAIN POSITIONS WHICH WAS NOT POSSIBLE AND THE ERROR MESSAGE APPEARS SYSTEMATICALLY; "THE TABLE HAS BEEN CHANGED" WAS NOTED. THE ACTIONS TAKEN TO RESOLVE THE ISSUE WERE THAT TWO GROUPS WERE SET UP: ONE FOR STANDING AND ANOTHER FOR LYING DOWN. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP CONFIRMED THAT THE INS WAS NOT ALIGNED PROPERLY DUE TO THE PATIENT'S BELLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1249864 | INTELLIS | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97715 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |