INCEPTIV
Report
- Report Number
- 3004209178-2025-04841
- Event Type
- Malfunction
- Date Received
- March 19, 2025
- Date of Event
- March 14, 2025
- Report Date
- April 16, 2025
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- UDI-DI
- 00763000540302
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
B3: DATE IS APPROXIMATE. MONTH AND YEAR ARE CONFIRMED VALID. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
B5: SECTION UPDATED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
CONTINUATION OF D10: PRODUCT ID FP9000M SERIAL# UNKNOWN: PRODUCT TYPE ACCESSORY MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL INFORMATION WAS RECEIVED FROM PATIENT. PATIENT CALLED BACK AND THEY GUESSED THEIR STIMULATION WAS TOO HIGH THAT IT WOULD DRAIN THEIR IMPLANT. THEY COULDN'T GET THE PROGRAM TO SET ON THE LEFT AS WELL. PATIENT CHARGED THE IMPLANT TO 100% YESTERDAY AND TODAY THE IMPLANT WAS AT 60%. PATIENT WOULD HAVE TO CHARGE AT LEAST EVERY OTHER DAY BUT THEY GOT THE IMPRESSION THAT THE IMPLANT LASTED ABOUT 10 DAYS BECAUSE THEY HAD A TRIAL FOR 10 DAYS AND THE TRIAL STIMULATOR DID NOT RUN DOWN. AGENT REVIEWED STIMULATION AND HOW IT WOULD AFFECT CHARGING FREQUENCY. DURING THE CALL PATIENT WAS ON GROUP A AND PROGRAM 1 WAS AT 9.1. PROGRAMS 2, 3, AND 4 WERE AT 4.7. PATIENT INCREASED PROGRAM 2 BUT THEY DIDN'T FEEL ANY TINGLING OR REALLY DIDN'T HAVE ANY PAIN. AGENT REDIRECTED PATIENT TO THEIR HCP. PATIENT WAS UNSURE OF WHO THEIR FOLLOW UP HCP WOULD BE. PATIENT HAD THEIR SURGEON AND THEIR HCP FOR THE TRIAL. AGENT ADVISED PATIENT TO CALL BOTH DOCTORS SO THAT THE DOCTORS COULD HELP THEM SET UP AN APPOINTMENT WITH A REPRESENTATIVE. AGENT PROVIDED/REVIEWED NAS PHONE NUMBER. PATIENT ALSO MENTIONED IT WAS DIFFICULT TO CHARGE THE IMPLANT BECAUSE THE BELT WAS TOO LOOSE AND THEY COULDN'T EVEN USE THE BELT. PATIENT DIDN'T PROVIDE EVENT DATE BUT DID MENTION THEY HAD TO LAY BACK ON THE BED AND PUT A CUSHION UNDER THEM TO WEDGE THE RECHARGER TO GET IN CONTACT WITH THEIR IMPLANT. PATIENT HAD THE LARGE (102-135 CM) SIZE BELT. PATIENT'S WAIST MEASUREMENT WAS 38 INCHES (96.52 CM). AGENT ORDERED THE MEDIUM (80-107 CM) BELT. AGENT CLOSED CASE. UPON FURTHER REVIEW REPRESENTATIVE RESPONDED AND ALSO MENTIONED THEY WOULD HANDLE THE PATIENT.
THE REASON FOR CALL WAS THE PATIENT STATED THAT THEY HAD A PAIN ON THE SIDE OF THEIR BACK AND THEY DIDN'T KNOW HOW TO MOVE THE STIMULATION TO THE MIDDLE OF THEIR BODY AND NEEDED ASSISTANCE TO ADJUST THE THERAPY. DURING THE CALL PATIENT RESET THE CONTROLLER AND CLOSED ALL APPS. PATIENT SUCCESSFULLY CONNECT THE COMMUNICATOR TO HANDSET. THEY SWITCH GROUP FROM C TO A. THE PATIENT INCREASED THE STIMULATION AND THEY FELT MUCH BETTER. THE TROUBLESHOOTING STEPS THAT WERE TAKEN ON THE CALL RESOLVED THE ISSUE.
INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS FOR THE PAST 3 DAYS THE PATIENT HAS NOT BEEN ABLE TO GET THEIR LOWER BACK ADJUSTED. PATIENT STATED THAT THEY WAKE UP AT NIGHT AND IT IS KILLING THEM AND THEY HAVE TO GET UP AND GET IN ANOTHER EASY CHAIR OUT OF THE BED. PATIENT MENTIONED THAT THEY HAD THIS PROBLEM THE NIGHT BEFORE AND THEY HAD TO READJUST AND ADD MORE INTENSITY BUT LAST NIGHT IT WAS THE SAME THING. PATIENT NOTED THAT THEY WEAR A CPAP MACHINE AND AT NIGHT WHEN THEY LAY ON THEIR BACK IT KILLS THEM. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. AGENT SENT AN EMAIL TO THE LOCAL MEDTRONIC REPS. REP EMAILED BACK AND REPORTED THEY WOULD CONTACT THE PATIENT.
ADDITIONAL INFORMATION WAS RECEIVED FROM PATIENT. PATIENT GOT REPLACEMENT BELT THAT WAS SENT BUT IT WAS STILL TOO LARGE. PATIENT REQ UESTED A SMALL SIZE BELT BE SENT. A REPLACEMENT SMALL SIZE BELT WAS SENT OUT.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. REP MENTIONED THE PATIENT WAS NOT HAVING ISSUES MAKING ADJUSTMENTS WITH THE DEVICE, PT'S COMPLAINT WAS THE SCS SYSTEM WAS NOT HELPING A SPECIFIC AREA IN HIS BACK AND HE NEEDED THE SETTINGS ¿ADJUSTED¿. IT HAS BEEN CONFIRMED BY THE IMPLANTING PHYSICIAN THAT THE CURRENT PAIN PT IS HAVING IS NOT NERVE RELATED. REP MENTIONED NO FURTHER ACTIONS NEEDED WITH THE DEVICE, THE PATIENT IS WORKING WITH THE HCP ON ALLEVIATING HIS ARTHRITIS SYMPTOMS AND THAT PT'S ISSUE WITH THE SCS SYSTEM HAS BEEN RESOLVED. INFORMATION HAS BEEN CONFIRMED / PROVIDED BY THE PHYSICIAN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 900684 | INCEPTIV | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 977119 | 00763000540302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Male | "SEE H11....".| "SEE H11....".| "SEE H11....". |