INTELLIS
Report
- Report Number
- 3004209178-2024-08113
- Event Type
- Malfunction
- Date Received
- March 29, 2024
- Date of Event
- February 14, 2024
- Report Date
- July 12, 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
- WA, US
- Reporter Occupation
- 003
Narratives
CONTINUATION OF D10: PRODUCT ID 97745 LOT# SERIAL# (B)(6) PRODUCT TYPE PROGRAMMER, PATIENT SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 97745, SERIAL/LOT #: (B)(6), UDI#: (B)(4). 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.
CONTINUATION OF D10: PRODUCT ID: 97745, SERIAL# (B)(6), PRODUCT TYPE: PROGRAMMER, PATIENT. H3: ANALYSIS OF THE 97745 CONTROLLER (PTM) (SERIAL NUMBER (B)(6)) REVEALED BLANK/WHITE/PIXEL MULTICOLOR/NO DISPLAY ON LCD. 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.
PATIENT WEIGHT OBTAINED 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.
CORRECTION: G3. 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 (PT) REGARDING AN EXTERNAL DEVICE. 97745 NLD096608N 97745BP THE REASON FOR CALL WAS LAST NIGHT THE PT WAS RECHARGING THE INS BATTERY LAST NIGHT THEN GOT SOFTWARE PROBLEM 1.INTELLIS 2.3.6 3.1546 4.APPMANAGER.C DURING CALL PT RESET THE CONTROLLER THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE. PATIENT CALLED BACK AND STATED THAT LAST NIGHT THEIR CONTROLLER POPPED UP WITH AN ERROR MESSAGE TO CALL MEDTRONIC AND THEN WENT BLANK. PATIENT STATED THEY THINK IT WAS THE SAME MESSAGE THEY SAW LAST TIME THEY CALLED, BUT THEY CAN'T REMEMBER ALL THE DETAILS. PATIENT NOTED THE CONTROLLER HAS BEEN ACTING UP FOR ABOUT A WEEK NOW WHERE IT WILL COME ON AND OFF SEVERAL TIMES. PATIENT NOTED THAT ONE TIME THEY WERE WALKING ACROSS THE PARKING LOT AND IT KICKED ON TO HIGH GEAR AND THEY COULD BARELY WALK. AGENT UNDERSTOOD PATIENT WAS REFERENCING THE STIMULATION COMING ON AND OFF AND ASKED PATIENT TO CLARIFY; PATIENT STATED IT HAPPENS COMPLETELY RANDOMLY AND NOT IN RELATION TO ANY POSITIONS OR ACTIVITIES BUT NOTED THAT IF THEY LAY BACK THEY GET REALLY JOLTED. PATIENT STATED THEY DON'T EVEN KNOW IF THE STIMULATION IS ON NOW BECAUSE THE CONTROLLER WON'T COME ON. AGENT WALKED PATIENT THROUGH REMOVING THE BATTERY PACK AND PLUGGING CONTROLLER INTO THE AC POWER CORD; CONFIRMED CONTROLLER POWERS ON. PATIENT INSERTED THE BATTERY PACK AND CONFIRMED CONTROLLER IS 0% AND IMPLANT IS 80%. PATIENT CONFIRMED THE CONTROLLER WAS RECHARGING AND STIMULATION IS ON. PATIENT NOTED THAT THEY USED TO AD JUST THE INTENSITY LEVELS WITH 0.2 INCREMENTS BUT NOW IT'S 0.1 INCREMENTS. PATIENT NOTED THEY DON'T WANT TO BE IN A SITUATION WHERE THE CONTROLLER IS UNRESPONSIVE WHEN THEY NEED TO CHANGE THEIR SETTINGS. AN EMAIL WAS SENT TO REPAIR TO REPLACE THE CONTROLLER.
PATIENT REPORTED DEVICE WAS SURGING FROM HIGH TO LOW STIMULATION AND IT WAS VERY PAINFUL. IS WAS NOT MAINTAINING A SETTING. PATIENT REPORTED THAT ISSUE HAS BEEN RESOLVED WITH REPLACEMENT.
INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN EXTERNAL DEVICE. 97745 NLD096608N 97745BP THE REASON FOR CALL WAS LAST NIGHT THE PT WAS RECHARGING THE INS BATTERY LAST NIGHT THEN GOT SOFTWARE PROBLEM 1.INTELLIS 2.3.6 3.1546 4.APPMANAGER.C DURING CALL PT RESET THE CONTROLLER THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE. PATIENT CALLED BACK AND STATED THAT LAST NIGHT THEIR CONTROLLER POPPED UP WITH AN ERROR MESSAGE TO CALL MEDTRONIC AND THEN WENT BLANK. PATIENT STATED THEY THINK IT WAS THE SAME MESSAGE THEY SAW LAST TIME THEY CALLED, BUT THEY CAN'T REMEMBER ALL THE DETAILS. PATIENT NOTED THE CONTROLLER HAS BEEN ACTING UP FOR ABOUT A WEEK NOW WHERE IT WILL COME ON AND OFF SEVERAL TIMES. PATIENT NOTED THAT ONE TIME THEY WERE WALKING ACROSS THE PARKING LOT AND IT KICKED ON TO HIGH GEAR AND THEY COULD BARELY WALK. AGENT UNDERSTOOD PATIENT WAS REFERENCING THE STIMULATION COMING ON AND OFF AND ASKED PATIENT TO CLARIFY; PATIENT STATED IT HAPPENS COMPLETELY RANDOMLY AND NOT IN RELATION TO ANY POSITIONS OR ACTIVITIES BUT NOTED THAT IF THEY LAY BACK THEY GET REALLY JOLTED. PATIENT STATED THEY DON'T EVEN KNOW IF THE STIMULATION IS ON NOW BECAUSE THE CONTROLLER WON'T COME ON. AGENT WALKED PATIENT THROUGH REMOVING THE BATTERY PACK AND PLUGGING CONTROLLER INTO THE AC POWER CORD; CONFIRMED CONTROLLER POWERS ON. PATIENT INSERTED THE BATTERY PACK AND CONFIRMED CONTROLLER IS 0% AND IMPLANT IS 80%. PATIENT CONFIRMED THE CONTROLLER WAS RECHARGING AND STIMULATION IS ON. PATIENT NOTED THAT THEY USED TO AD JUST THE INTENSITY LEVELS WITH 0.2 INCREMENTS BUT NOW IT'S 0.1 INCREMENTS. PATIENT NOTED THEY DON'T WANT TO BE IN A SITUATION WHERE THE CONTROLLER IS UNRESPONSIVE WHEN THEY NEED TO CHANGE THEIR SETTINGS. AN EMAIL WAS SENT TO REPAIR TO REPLACE THE CONTROLLER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2592830 | INTELLIS | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97715 | 00643169781702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Female | "SEE H11...." |