PRIMEADVANCED
Report
- Report Number
- 3004209178-2013-04510
- Event Type
- Malfunction
- Date Received
- April 2, 2013
- Report Date
- March 25, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 377775, LOT# V005101, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 377775, LOT# V005101, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).
(B)(4).
(B)(4).
IT WAS REPORTED THAT A PATIENT HAD STIMULATION IN THE WRONG LOCATION. THE REPORTER STATED THAT THE PATIENT'S DESIRED STIMULATION LOCATION WAS IN HER LOWER BACK, AND ABOUT A MONTH PRIOR TO THE REPORT THE STIMULATION STARTED GOING ALL THE WAY DOWN TO HER LEFT FOOT CAUSING PAIN IN THE FOOT. IT WAS NOTED THAT THE AFTER THE PATIENT TURNED OFF STIMULATION HER LEG THROBBED. THERE WAS NO KNOWN FALL OR TRAUMA ASSOCIATED WITH THE EVENT. ELEVEN DAYS LATER, IT WAS REPORTED THAT THE PATIENT HAD SEEN HER DOCTOR AND MANUFACTURER REPRESENTATIVE AND HER DEVICE WAS REPROGRAMMED. THE REPORTER STATED THAT THE MANUFACTURER REPRESENTATIVE HINTED THAT THE LEAD MAY HAVE MIGRATED A BIT. IT WAS REPORTED THAT THE PATIENT WAS STILL HAVING PROBLEMS WITH THE DEVICE OR THERAPY. IT WAS NOTED THAT STIMULATION FELT GOOD AT THE END OF A PROGRAMMING SESSION ON (B)(6) 2013 AND A SECOND GROUP WAS PROGRAMMED, BUT AS TIME WENT ON THE PATIENT NOTICED THAT THE STIMULATION WAS STILL GOING TOO FAR TO THE RIGHT. IT WAS REPORTED THAT THE PATIENT PLANNED TO CONTACT THE MANUFACTURER REPRESENTATIVE AGAIN IN A COUPLE OF WEEKS FOR ANOTHER APPOINTMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
IT WAS FURTHER REPORTED THE PATIENT IS FEELING STIMULATION IN THEIR STOMACH RATHER THAN IN THEIR LOW BACK AND LEFT LEG AND SCIATIC AREA. IT WAS REPORTED THAT NO MATTER WHAT IS DONE THEY CANNOT GET STIMULATION IN THE RIGHT LOCATION. IT WAS NOTED, THE PATIENT IS HAVING ¿A LOT OF PAIN IN THEIR NECK AND SHOULDER ARE TOO¿. IT WAS NOTED, THE PATIENT REQUESTED A NEW PHYSICIAN BECAUSE, THEY WILL NOT REMOVE THEIR DEVICE DUE TO SCAR TISSUE. IT WAS NOTED, THE PATIENT WANTS THEIR DEVICE REMOVED TO GET AN MRI FOR THE PAIN IN THE NECK AND SHOULDER. IT WAS NOTED, THE PATIENT HAS NOT USED THEIR DEVICE IN ¿A COUPLE YEARS NOW¿. IT WAS NOTED THE PATIENT HAS HAD TWO BACK SURGERIES FOR BLOWN DISCS PRIOR TO BEING IMPLANTED WITH THEIR DEVICE. INFORMATION OMITTED PERTAINING TO RELATED EVENT (B)(6) ¿ IMPLANTED ON WRONG SIDE.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAS A LOSS OF THERAPEUTIC EFFECT. IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) IS WORKING BUT "NOT DOING WHAT IT SHOULD" AND "KEEPS GOING OUT OF THE AREA IT SHOULD". IT WAS NOTED THE PATIENT HAS OTHER AREAS OF PAIN AND THEIR PAIN "IS NOT WIDE SPREAD". IT WAS MENTIONED THAT THE EVENT DATE WAS UNCLEAR HOWEVER THE PATIENT REPORTED IT WAS "A WHILE AGO". IT WAS NOTED THAT WHEN THE PATIENT WAS REPROGRAMMED "A YEAR AGO�HAT SHORTLY AFTER THE "STIM GOES TO THE WRONG LOCATION" SUCH AS THEIR LEG OR STOMACH. IT WAS REPORTED THE PATIENT IS HAVING THEIR DEVICE REMOVED FOR TESTS/MRIS AND BECAUSE THEY ARE NOT GETTING THE BENEFIT THEY NEED FROM THE INS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134540 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |