INTELLIS
Report
- Report Number
- 3004209178-2024-12026
- Event Type
- Injury
- Date Received
- May 31, 2024
- Report Date
- June 19, 2024
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- 003
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.
ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE REPORTED THAT AN IMPEDANCE CHECK SHOWED ALL WERE WITHIN NORMAL LIMITS AND A CONNECTION CHECK WAS ALL GREEN. THE PATIENT WAS ON DTM PROGRAMMING AND HAD NO DIFFERENCE IN NERVE PAIN WITH THE STIMULATOR ON. THE PATIENT NOTED THE SKIN AROUND THE IMPLANT AND SOMETIMES DOWN THE LEG WOULD GET HOT TO THE TOUCH SPORADICALLY THROUGHOUT THE DAY WITH THE STIMULATOR ON. THE PATIENT TURNED THE STIMULATION OFF A FEW DAYS AGO AND THE BATTERY HAD NOT BEEN HOT. THE PHYSICIAN RECOMMENDED THE PATIENT STIMULATION STAY OFF.
INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PATIENT REPORTED THE IMPLANT HADN'T DONE ANYTHING FOR THEM OR THEY DIDN'T THINK THE STIMULATION WAS WHERE THEY THOUGHT IT SHOULD BE. PATIENT STILL WOKE UP IN PAIN AND KEPT A LIST OF WHEN TO TAKE THEIR MEDICINE. PATIENT HAD SEVERE PAIN AND THEY HAD NO CUSHION FROM THEIR NECK TO THEIR TAILBONE AND IT WAS BONE ON BONE. PATIENT WAS HOPING THE IMPLANT WOULD RESOLVE THE ISSUE. AGENT REDIRECTED PATIENT TO THEIR HEALTHCARE PROVIDER (HCP) TO ADDRESS THE ISSUE. PATIENT HAD A PREVIOUS COMPETITOR DEVICE AND WHEN THEIR HCP RETIRED THEY WENT TO ANOTHER HCP WHO USED THE CURRENT DEVICE AND THEY HAD TO GO BACK IN AND DID SOMETHING TO THE IMPLANT IN THEIR BACK. PATIENT WOULD HAVE TO GO IN ON THE 15TH TO GET NUMBED ON THEIR 'ENDING'.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1399745 | INTELLIS | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 97716 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Required Intervention |