INTELLIS
Report
- Report Number
- 2182207-2022-01623
- Event Type
- Malfunction
- Date Received
- August 23, 2022
- Date of Event
- August 19, 2022
- Report Date
- November 7, 2022
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- UDI-DI
- 00763000278762
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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.
INFORMATION WAS RECEIVED FROM A TRIAL PATIENT VIA MANUFACTURER REPRESENTATIVE WHO WAS USING AN EXTERNAL NEUROSTIMULATOR (ENS) FOR UN KNOWN INDICATIONS FOR USE. THE CALLER (REP) REPORT THAT THEY JUST PLACED TRIAL LEADS TO TREAT CRPS AND GOT GOOD COVERAGE INITIALLY. CALLER STATED THE PATIENT (PT) WAS FEELING STIMULATION IN THEIR RIGHT ARM AND FINGERS AND SHORTLY AFTER, PT WAS NO LONGER FEELING THE SAME COVERAGE AND WAS ONLY FEELING STIMULATION IN THEIR RIGHT UPPER ARM (UNDER ARM TO ELBOW). CALLER MENTIONED THEY REPLACED THE WENS IN ATTEMPT TO RESOLVE THE ISSUE AND ALSO REPORTED THAT ELECTRODE 2 DISPLAYED A HIGH IMPENDENCE VALUE. ANOTHER MDT REP WAS ATTEMPTING TO REPROGRAM DURING THE CALL AND FURTHER TROUBLESHOOTING WAS UNABLE TO BE PERFORMED. CALLER WILL CALL BACK IF FURTHER ASSISTANCE IS NEEDED. CALLER STATED PT IS TIFFANY JONES AND MANAGING HCP IS DR. HALL. MDT REP, BROOKE CHATEAU CALLED BACK AND AND REPORTED THEY PROGRAMMED ELECTRODES 3, 4, <(>&<)> 5. CALLER CONFIRMED IMPEDANCE VALUES OF 3, 4, <(>&<)> 5 ARE AS FOLLOWS : REF 0 3 - 1470 OHMS 4 - 1380 OHMS 5 - 1140 OHMS REF 3 4- 1280 OHMS 5- 1080 OHMS REF 4 5- 1050 OHMS CALLER CONFIRMED ELECTRODES 1, 2, <(>&<)> 9 HAD THE FOLLOWING IMPENDENCE VALUES: 1- 10840 OHMS 2 - 40000 OHMS 9- 26840 OHMS. CALLER INDICATED THAT THEY ATTEMPTED TO PROGRAM ELECTRODE CONFIGURATIONS ALONG THE LENGTH OF THE LEAD BUT WAS UNABLE TO ACHIEVE THE DESIRED COVERAGE. CALLER STATED WHEN THEY INITIALLY PROGRAMMED PT, PULSE WIDTH WAS SET TO 450. CALLER STATED AFTER PT REPORTED ONLY FEELING STIMULATION IN ARM AND ELBOW, THEY INCREASE PULSE WIDTH TO 750 AND PT SAID THEY WERE ABLE TO FEEL BETTER COVERAGE. TSS REVIEWED PROGRAMMING OPTIONS. MDT REP, BROOKE CHATEAU CALLED BACK AND AND REPORTED HE HAD CHANGED OUT THE WENS BEFORE CALLING. CALLER NOTED IMPEDANCE VALUES AT 67 870 AND 01 2690 03 1450. REVIEWED TARGETING THOSE WITH LOWER IMPEDANCES AND TRY LD TO SEE IF PATIENT CAN FEEL THAT STIM. PATIENT IS CURRENTLY PROGRAMMED AT 1000 RATE AND 90PW AND NOT FEELING ANY STIM. CALLER CALLED BACK AND NOTES HE IS MEETING WITH PT TODAY. CALLER STATES PT IS STILL NOT FEELING ANY STIMULATION EVEN THOUGH WHEN HE LEFT THE PT THE PT'S IMPEDANCES WERE GOOD. ON ONE LEAD PT FELT STIM AROUND 8MA WITH A LITTLE STIM UNDER HER LEFT ARM AND IT WOULD FEEL LIKE TIGHTNESS IN HER CHEST. TSS REVIEWED MAKING SURE THAT PROGRAMMING IS FOCUSED ON CONTACT PAIRS THAT HAVE VIABLE IMPEDANCES.
ADDITIONAL INFORMATION WAS RECEIVED FROM REP STATING, HIGH IMPEDANCES WERE DISCOVERED ON DAY OF EVENT BUT THEY REDUCED TO NORMAL LEVELS BY DAY TWO. THE EXACT CAUSE OF THE ISSUE WAS NOT DETERMINED, BUT IT WAS THE FACT THAT PHYSICIAN USED SALINE WHEN FINDING LOSS OF RESISTANCE AS IMPEDANCES CALMED DOWN AND PATIENT FELT STIMULATION WITHIN TWO DAYS. IMPEDANCES WENT BACK TO NORMAL AND STIMULATION WAS FELT AT TWO DAYS AND THE ISSUES WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2352720 | INTELLIS | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | MEDTRONIC NEUROMODULATION | 97725 | 00763000278762 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |