INTELLIS
Report
- Report Number
- 3004209178-2022-07112
- Event Type
- Injury
- Date Received
- June 3, 2022
- Date of Event
- April 23, 2022
- Report Date
- March 14, 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
- TX, US
- Reporter Occupation
- 003
Narratives
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.
CONTINUATION OF D10: PRODUCT ID 977A260 LOT# SERIAL# (B)(6), IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 977A260 LOT# SERIAL# (B)(6), IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD. 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.
CONTINUATION OF D10: PRODUCT ID 977A260 LOT# SERIAL# (B)(6) IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 977A260 LOT# SERIAL# (B)(6) IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD 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 WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT STATED FOR THE LAST WEEK, WEEK AND A HALF AGO THEY WERE NOT ABLE TO ADJUST THE STIMULATION. THE PATIENT REPORTED RECEIVING SETTINGS NOT AVAILABLE ON EITHER PROGRAM. THE PATIENT TRIED TO RESET CONTROLLER LIKE REP TOLD THEM, BUT THAT DIDN'T HELP. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THE REP REITERATED THE SETTINGS NOT AVAILABLE MESSAGE AND INDICATED THAT THEY MET WITH THE PATIENT AND THE NOTED THEIR LEAD WAS NOT FUNCTIONING AND LATER EXPLAINED THAT THE IMPEDANCES FOR ELECTRODES 0-7 WERE ALL >40000OHMS THE CALLER INDICATED THAT THE HCP PLANS TO COMPLETE A LEAD REVISION BUT THEY DON'T KNOW WHEN.
REP REPORTS PATIENT WAS PART OF THE STUDY WITH SGX, WHERE THEY SAW THE REP FOR THE FIRST 6 MONTHS AFTER IMPLANT, THEN FOLLOWED UP WITH SGX AND THEN CAME BACK TO THE EP. REP STATES THAT WHEN THE PATIENT WAS INITIALLY SEEING HER, A FEW ELECTRODES ON THEIR LEAD WENT OUT AND SLOWLY MORE BEGAN TO GO OUT TO THE POINT WHERE THEY SWITCHED PROGRAMMING OVER TO THE OTHER LEAD. WHEN THEY TRANSITIONED TO SGX, SLOWLY, ALL THE ELECTRODES (STARTED AS 8 AND 9, THEN 11 AND 12, AND MORE), EXCEPT ELECTRODES 6 AND 7 WENT OUT ON BOTH LEADS. REP STATES AT THAT TIME, IMPEDANCE CHECK REVEALED ALL OF ONE LEAD STATED "DO NOT USE" AND THE "TWO BOTTOM ONES STATE AVOID". REP REPORTS THE STUDY COORDINATOR STATED THAT IMAGING WAS DONE WITH SGX OF THE LEADS, WHICH REVEALED NO LEAD MIGRATION. NOW THAT THE PATIENT HAS TRANSITIONED BACK TO THE REP, THE REP REPORTS THAT THEY WERE ABLE TO PROGRAM THE PATIENT ON ELECTRODES 6 AND 7 ABOUT TWO WEEKS AGO, AND PATIENT REPORTED THEY WERE ABLE TO FEEL STIMULATION, ESPECIALLY WHEN COUGHING OR POSITIONED A CERTAIN WAY. PATIENT THEN REPORTED TO REP THAT THEY ARE SEEING A SCREEN THAT STATES "CANNOT DELIVER DESIRED INTENSITY". REP MET WITH PATIENT AGAIN TODAY AND REPORTS ALL IMPEDANCES ON ALL ELECTRODES ARE OVER 40,000 AND ARE MARKED AS AVOID (6-15) AND X (0-5). REP STATES SHE TRIED GETTING THE PATIENT SOME STIMULATION SENSATION BY INCREASING PULSE WIDTH, AND INTENSITY TO 7 MA, BUT THE PATIENT IS UNABLE TO FEEL ANYTHING. THE CALLER WAS NOT WITH THE PATIENT, BUT STATES PATIENT IS WORRIED ABOUT HAVING A LEAD REVISION. REP ALSO REPORTS SGX NOTIFIED PATIENT THEY WOULD PAY FOR THE LEAD REVISION. TS ADVISED REP TO HAVE PATIENT MEET WITH THEIR HCP, AS WELL AS CONSULT THE POSSIBILITY OF IMAGING AT THE BATTERY SITE TO ASSESS ANY POSSIBLE LOOSE COMPONENTS. TS EMAILED PRINCIPAL REGARDING THIS SITUATION AND WILL FOLLOW-UP WITH REP IF FURTHER TROUBLESHOOTING IS WARRANTED.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT SAID HE CAN FEEL THE 20MIN ON/20 MIN OFF CYCLING AS IT SHOULD SO ALL IS OK. THE THERAPY IS EFFECTIVE IN TREATING PT'S PAIN. THERE WAS NO LEAD REVISION DONE.
REP REPORTED NOTHING FURTHER HAS HAPPENED. REP TALKED TO THE PATIENT AND TOLD HIM SINCE ALL ELECTRODES WERE OUT THERE WASN'T ANY PROGRAMMING REP COULD DO AND HE WOULD NEED LEAD REVISION. HE IS STILL DECIDING IF THAT¿S WHAT HE WANTS TO GO FORWARD WITH.
INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PT STATED THEY HAD ONE LEAD GO BAD AFTER LIKE 3 MONTHS SO EVERYTHING HAD TO BE RUN OFF THE SECOND LEAD (SEE (B)(6)) AND PT THOUGHT THE SAME ISSUE HAD NOW HAPPENED WITH THE SECOND LEAD. PT SAID STARTING IN NOVEMBER OR DECEMBER, THEY STARTED TO SEE "OUT OF RANGE" AND PT COULDN'T ADJUST SETTINGS. PT SAID THE THERAPY WASN'T HELPING AND THEIR PAIN LEVEL WAS SIGNIFICANTLY WORSE. PT MENTIONED THEY WERE PART OF A TRIAL, BUT THAT HAD JUST ENDED. PT SAID THEY MET WITH THE MANUFACTURING REPRESENTATIVE (REP) IN DECEMBER AND 2 OUT OF THE 8 CONTACTS WERE BAD/HAD IMPEDANCES AND THEN WHEN THEY MET WITH THE REP AGAIN ON JANUARY 3RD, 4 HAD IMPEDANCES. PT SAID NOW THEY THOUGHT THERE WAS MORE AND SAID WHEN THE REP ADJUSTED PROGRAMMING IN JAN TO WORK AROUND IMPEDANCES, A AND C STOPPED WORKING/WERE OUT OF RANGE WITHIN 10 MINUTES. PT SAID B WORKED UNTIL FRIDAY BUT THEN THEY STARTED TO SEE THE SAME THING - OUT OF RANGE. PT SAID THEY TRIED C AGAIN AND COULD FEEL PARASTHESIA WHEN LAYING DOWN, BUT THERAPY STILL WASN'T WORKING. PT ASKED IF THERE WAS SOMEONE FROM MDT THEY COULD MEET WITH TO CHECK ON THE DEVICE NOW THAT THE TRIAL JUST ENDED. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1979194 | INTELLIS | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97715 | 00763000315467 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Male | Required Intervention |