INTELLIS
Report
- Report Number
- 3004209178-2018-24333
- Event Type
- Malfunction
- Date Received
- October 31, 2018
- Date of Event
- October 19, 2018
- Report Date
- July 9, 2021
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00643169781702
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO IS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR. THE MANUFACTURER REPRESENTATIVE REPORTS PATIENT HAS INS IMPLANTED TO CONTROL THE PATIENT'S HEADACHES AND PATIENT INDICATED THE STIMULATOR HAS BEEN CONTROLLING HER HEADACHES, CERVICAL IMPLANT. MANUFACTURER REPRESENTATIVE REPORTS SHE IS SEEING PATIENT FOR REPROGRAMMING. MANUFACTURER REPRESENTATIVE REPORTS ONE OF THE LEADS, 0-7 LEAD, ONLY HAS TWO ELECTRODES THAT ARE WORKING. PATIENT IS USING ELECTRODE 2/4. MANUFACTURER REPRESENTATIVE REPORTS SEEING SETTINGS NOT AVAILABLE. CANNOT PROVIDE YOUR DESIRED INTENSITY SETTINGS. ELECTRODE IMPEDANCE: REFERENCE 0: ALL ELECTRODES 40K OHMS. REFERENCE 1: 2: 3950 OHMS REFERENCE 2: ELECTRODE 8-15: LOWEST IMPEDANCE IS ELECTRODE 10: 930 OHMS, 8: 980 OHMS, 9: 950 OHMS, 10: 930 OHMS, 11: 970 OHMS, 12: 1090 OHMS, 13: 1140 OHMS, 14: 1360 OHMS, 15: 1350 OHMS, 1: 39580 OHMS, 3-7: 40K OHMS REFERENCE 3: ELECTRODE 8-15: AROUND 3120 OHMS 2: 32020 OHMS, 4: 37600 OHMS REFERENCE 4: ELECTRODE 8-15: ELECTRODE 16 AND 17: 18K OHMS, 2: 9830 OHMS, 3: 37600 OHMS REFERENCE 5: 2: 29820 OHMS ELECTRODE 8-15: AROUND 27K OHMS REFERENCE 6: ALL 40K OHMS REFERENCE 7: 2:3990 OHMS.
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED, THAT THE PATIENT WAS PROGRAMMED. AND RECEIVING GOOD RESULTS.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INFORMATION WAS RECEIVED FROM A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) VIA A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT¿S CONTROLLER WAS SHOWING A ¿SETTINGS NOT AVAILABLE¿ SCREEN FOR THE PAST TEN DAYS. IT WAS REPORTED THAT ELECTRODE 5 HAD IMPEDANCES OF 23,000 OHMS AND ELECTRODE 7 HAD IMPEDANCES OF 40,000 OHMS. THE PATIENT¿S INS WAS REPROGRAMMED TO AVOID ELECTRODE 7 AND THE ISSUE WAS RESOLVED. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 864773 | INTELLIS | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97715 | 00643169781702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |