INTELLIS
Report
- Report Number
- 3004209178-2023-00115
- Event Type
- Malfunction
- Date Received
- January 4, 2023
- Date of Event
- December 3, 2022
- Report Date
- February 1, 2023
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00763000315467
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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.
INFORMATION WAS RECEIVED FROM A PATIENT VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. A MDT REP CALLED AND REPORTED THAT ABOUT 1 MONTH AGO PT STATED THEY BEGAN EXPERIENCING A BURNING SENSATION AT THE INS SITE THAT "FEELS LIKE THE INCISION IS OPENING". PT REPORTED THAT THEY SLEEP ON THEIR RIGHT SIDE WHERE THEIR INS IS LOCATED, BUT REPORTED THIS HAS NOT CHANGED IN THE LAST MONTH OR TWO. PT DENIED ANY FALLS, TWISTS, OR OTHER TRAUMA AROUND THE TIME THE PAIN STARTED. PT REPORTED THAT THEY MET WITH THEIR HEALTHCARE PROVIDER (HCP) 1 WEEK AGO AND OBTAINED X-RAY IMAGING AND TURNED STIMULATION OFF. PT REPORTED THAT STIM REMAINED OFF FOR THE WEEK AND THEY DID NOT EXPERIENCE BURNING AT THE INS SITE DURING THAT TIME. MDT REP WAS NOTIFIED AT TODAY'S MEETING, AND REPORTS THAT THEY ARE MEETING WITH HCP SOON AND WILL REVIEW IMAGING. MDT REP REPORTED THE FOLLOWING IMPEDANCE VALUES WITH REFERENCE ELECTRODE 0: 1=930, 2=910, 3=950, 4=940, 5=880, 6=970, 7=920, 8=1890, 9=1760, 10=980 11=1400, 12=960, 13=940, 14=940, 15=1010. WHEN REFERENCE ELECTRODE CHANGED TO 8, IMPEDANCE VALUE FOR 9=2980. MDT REP REPORTED THAT THE PT'S CURRENT PROGRAMMING DOES NOT USE CONTACT 8, BUT DOES USE CONTACT 9 FOR 1 PROGRAM IN GROUP A. ALL OTHER REFERENCE ELECTRODES SHOW SIMILAR VALUES TO REFERENCE ELECTRODE 0 VALUES LISTED ABOVE. IMPEDANCE VALUE DATA WAS REVIEWED AND THE MDT REP INDICATED THEY WILL CALL BACK WITH FURTHER QUESTIONS OR X-RAY RESULTS.
REP REPORTED THAT THE TRUE CAUSE WAS UNDETERMINED. IMPEDANCES WERE NORMAL, BUT TECH SERVICES SAID IF FLUID GETS INSIDE THE PORT OF THE INS, THIS MAY CAUSE A BURNING SENSATION. THE PHYSICIAN HAD INSIGHT REGARDING CHARGING AND REEDUCATED THE PATIENT ON THAT IN CASE THE SITE GOT WARM WHEN CHARGING. THE PHYSICIAN REEDUCATED THE PATIENT ON CHARGING, BELIEVING THIS MAY HAVE IMPACTED THE SENSATION. THE PHYSICIAN DECLARED THE X-RAYS TO BE NORMAL. THE ISSUE WAS RESOLVED. WEIGHT WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1471029 | INTELLIS | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97715 | 00763000315467 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female |