INTELLIS
Report
- Report Number
- 3004209178-2021-05856
- Event Type
- Malfunction
- Date Received
- April 12, 2021
- Date of Event
- April 8, 2021
- Report Date
- May 10, 2021
- 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
- MA, US
- Reporter Occupation
- 003
Narratives
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS REC'D FROM THE REP. IT WAS REPORTED THAT PATIENT HAS BEEN EXPERIENCING SHOCKING SENSATION WHEN PATIENT LAYS DOWN AND IN A CURL UP POSITION. SITTING AND STANDING PATIENT FEELS FINE. REP INTERROGATED INS, IMPEDANCE SHOWS: REFERENCE 7: 13: 190 OHMS THE REST IS GREEN REFERENCE 13: 7: 190 OHMS THE REST IS GREEN. PATIENT STANDS UP THE IMPEDANCE ARE ALL GREEN. THE LEAD CONNECTIVITY ARE ALL GREEN. PATIENT HAS BEEN REPROGRAMMED, NOT USING ELECTRODE 7/13, BUT PATIENT FEELS STIMULATION IS TOO INTENSE ON HIS RIGHT LEG, UPPER THIGH: C1: 3-5+ 1.0MA C2: 14-12+ 1.4MA C3: 14-12+ 1.4MA C4: 14-12+ 1.4MA ADAPTIVE STIMULATION IS OFF AND NOT CONFIGURATED. PATIENT DOES NOT FEEL THE INTENSE STIMULATION WHEN STIMULATION IS TURNED OFF. INS IS IMPLANTED ON PATIENT'S LEFT SIDE, BELTLINE. ELECTRODE IMPEDANCE TESTED WHEN PATIENT IS LAYING DOWN. REFERENCE 0 1: 1970 OHMS 2: 1900 OHMS 3: 1970 OHMS 4: 1830 OHMS 5: 1740 OHMS 6: 1720 OHMS 7: 1710 OHMS REFERENCE 1 0: 1970 OHMS 2: 1670 OHMS 3: 1790 OHMS 4: 1680 OHMS 5: 1590 OHMS 6: 1570 OHMS 7: 1570 OHMS REFERENCE 3 4: 1540 OHMS 5: 1500 OHMS 6: 1500 OHMS 7: 1510 OHMS 8: 1770 OHMS 9: 1980 OHMS 10: 1470 OHMS 11: 1510 OHMS 12: 1430 OHMS 13: 1430 OHMS 14: 1290 OHMS 15: 1400 OHMS REFERENCE 5 0: 1740 OHMS 1: 1590 OHMS 2: 1480 OHMS 3: 1500 OHMS 4: 1350 OHMS 6: 1190 OHMS 7: 1250 OHMS 8: 1620 OHMS 9: 1900 OHMS 10: 1300 OHMS 11: 1020 OHMS 12: 1120 OHMS 13: 1170 OHMS 14: 1060 OHMS 15: 1160 OHMS REFERENCE 12 0: 1660 OHMS 1: 1510 OHMS 2: 1400 OHMS 3: 1430 OHMS 4: 1330 OHMS 5: 1120 OHMS 6: 790 OHMS 7: 1140 OHMS 8: 1520 OHMS 9: 1680 OHMS 10: 1260 OHMS 11: 1160 OHMS 13: 1060 OHMS 14: 990 OHMS 15: 1110 OHMS REFERENCE 14 0: 1490 OHMS 1: 1350 OHMS 2: 1250 OHMS 3: 1290 OHMS 4: 1190 OHMS 5: 1060 OHMS 6: 1020 OHMS 7: 940 OHMS 8: 1360 OHMS 9: 1530 OHMS 10: 1130 OHMS 11: 1080 OHMS 12: 990 OHMS 13: 890 OHMS 15: 890 OHMS CALLER REPORTS PATIENT NEEDS COVERAGE FOR LOWER BACK AND BOTH LEGS DOWN TO THE FEET. PATIENT WAS USING ELECTRODE: FOR THE MORNING, GROUP A. A1: 1-4+ AND A2-4: 5-7+ FOR THE EVENING, GROUP B. B1: 10-12+ AND B2-4: 11-13+ SUGGEST USING ELECTRODE: 6/12; 7/14; 14/12; PATIENT FEELS STIMULATION ON THE RIGHT SIDE FROM BELT LINE TO THE KNEE AT 1.1MA, 1.0MA. POST OP X-RAY SHOWS 1 LEAD WAS MIDLINE AND THE OTHER WAS MORE TOWARDS THE RIGHT SIDE. NO LATERAL VIEW OF THE X-RAY WAS SEEN, JUST ANTERIOR X-RAY. WHEN PATIENT CHECKED HIS CONTROLLER AT HOME, WHEN STIMULATION WAS OFF, PATIENT NOTICED HIS PROGRAMS WAS CHANGED ON HIS OWN. CALLER CONFIRMED PATIENT'S ADAPTIVE STIMULATION IS NOT CONFIGURED. REPROGRAMMED USING ELECTRODE: 0/6; 0/1: PATIENT FEELS STIMULATION ON HIS SIDE TOWARDS THE RIB DOWN TO HIS KNEE ON THE RIGHT. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. SHUT EVERYTHING OFF. X-RAY PLANNED. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.
REP RESPONDED FROM FOLLOW UP SENT. WAITING ON XRAY BUT AT FIRST IT WAS THOUGHT TO JUST BE A DEVICE ISSUE THEN AFTER REP MET WITH THE PATIENT AND SPENT AN HOUR ON THE PHONE WITH TECH SERVICES THEY SAID TO SHUT IT OFF, GET AN X-RAY AND THE LEAD MAY NOT BE IN THE RIGHT PLACE. PATIENT STATED HE FELT LIKE HE WAS PUTTING HIS FINGER INTO AN ELECTRICAL SOCKET. SHOCKS FROM RIGHT RIB TO ABOUT RIGHT KNEE. NOT INFORMED OF RESULTS YET. TECH SERVICES STATED THE DAY I FILLED OUT THIS REPORT TO SHUT THE DEVICE OFF. NO ACTIONS TO RESOLVE YET. WAITING FOR XRAY TO RESOLVE.
ADDITIONAL INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE X-RAYS SHOWED BOTH LEADS POSTERIOR. REPROGRAMMED PT DIFFERENTIAL TARGET MULTIPLEXED (DTM), CHECK DTM LAYING DOWN AND APPLIED APPROPRIATE PROGRAMMING. PT GETTING RELIEF AND DOING WELL.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A PATIENT VIA MANUFACTURER REPRESENTATIVE (REP) WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT TOOK BATTERY OUT OF CONTROLLER. INFORMATION NOT CLARIFIED. USED A FOR DAY TIME. USES B FOR DAYTIME NOW BUT MOSTLY LIKES AT NIGHT. TROUBLE CHARGING! GIVE EDUCATION LOW BACK HIP RIGHT SIDE ALL THE DOWN TO FOOT. SHOCKS ON RIGHT SIDE. REP DID SOME REPROGRAMMING OVER PHONE. A 1.6 A 1.8. SWITCHED A 1 TO 1.2 AND A2,3,4 TO 1.0. B1- 1.1 B2,3 ,4 0.9. C1- 0.9 C2,3,4- 1.1. STIMULATOR SHUTS OFF WHEN SWITCHING GROUPS AS WELL. MEETING PATIENT IN OFFICE 4/14 TO GO OVER EVERYTHING. THE ISSUE IS NOT RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 547167 | INTELLIS | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97715 | 00643169781702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR |