SYNERGY
Report
- Report Number
- 3004209178-2012-09461
- Event Type
- Malfunction
- Date Received
- October 24, 2012
- Report Date
- September 24, 2012
- 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
- MI, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 7435, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 399930, LOT# V002755, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).
IT WAS REPORTED THAT THE PATIENT HAD A SURGING SENSATION. THE PATIENT'S SYMPTOMS WERE NOTED AS MOVEMENT CAUSED STIMULATION CHANGES. THE PATIENT WAS NO LONGER USING THE DEVICE ANYMORE, AS IT WAS NOT SERVING THE PURPOSE OF CONTROLLING HER PAIN, AND HAD NOT USED IT IN OVER A YEAR. IF THE PATIENT WALKED ON CARPET, BENT OR DID ANYTHING, IT CHANGED THE STIMULATION AND IT WENT UP AND SURGED. THE PATIENT GOT TO THE POINT WHERE IT BECAME VERY UNCOMFORTABLE DUE TO POSITIONAL MOVEMENT AND TO WHERE SHE WAS TURNING IT OFF AND ON SO MUCH SHE JUST STOPPED USING IT. THE BOX WAS NOW BULGING AND IT HURT, AND IF SHE LAID ON IT OR MOVED IT CAUSED PAIN. THE PATIENT WAS STILL CONTINUING TO HAVE PAIN IN HER LEFT LEG, TOES AND BACK. BEFORE IMPLANT, SHE WAS HAVING PAIN DOWN HER BACK INTO BOTH OF HER LEGS AND HER TOE, ALTHOUGH IT WAS MORE ON HER LEFT SIDE. WHEN THE HCP (HEALTH CARE PROFESSIONAL) DID THE MRI PRIOR TO THE IMPLANT, THEY SAW THE DAMAGE ON THAT LEFT SIDE WHERE NERVES WERE BEING PINCHED AND THE PATIENT WAS HAVING SPASMS ON THE UPPER PART OF HER BACK. SHE UNDERWENT INJECTIONS, ETC., AND HAD SURGERY ON HER LEFT SIDE EVENTUALLY THAT HELPED FOR A WHILE AND ALL THE TIME THE RIGHT SIDE KEPT GETTING WORSE. THE PATIENT STATED THAT THE HCP TOLD HER THAT SINCE HER LEFT SIDE WAS DAMAGED, THEY FELT THE RIGHT SIDE WAS AN EFFECT FROM PATIENT LEANING ON RIGHT SIDE DUE TO HER LEFT SIDE ISSUES. PATIENT STATES SHE KEPT COMPLAINING ABOUT HER RIGHT SIDE. PATIENT STATES SHE CAN'T REMEMBER IF IT WAS A CT SCAN, MRI OR X-RAY BUT HCP EVENTUALLY FOUND DAMAGE ON THE RIGHT SIDE TOO. PATIENT STATES THAT HCP SUGGESTED SURGERY AGAIN BUT THERE WAS ONLY A POTENTIAL 50/50 CHANCE TO RELIEVE THE PAIN, WHICH WAS THE REASON WHY SHE WAS IMPLANTED WITH THE PAIN STIMULATION SO SHE WOULDN'T HAVE TO HAVE ANOTHER SURGERY. THE PAIN HAS COME BACK NOW AND HCPS ARE TELLING HER THAT IT IS DUE TO SCAR TISSUE BUILDUP AND IT DIDN'T SEEM TO MAKE SENSE TO DO SURGERY AGAIN FOR THIS REASON. SHE STILL HAS PAIN DOWN HER BACK, BOTH LEGS AND DOWN TINGLING INTO HER TOES, WHICH WAS MORE OFTEN TO THE LEFT SIDE AND WAS STILL HAVING MUSCLE SPASMS IN THE UPPER PART OF HER BACK TOO. THE LOWER PART OF HER BACK WHERE HER BUTT IS, SHE HAD A LOT OF PAIN THERE IF SHE LIFTED ANYTHING, BENT OR TWISTED AND THEN HER BACK WOULD GO OUT AND SHE WENT TO THE GROUND. THE PATIENT WAS REPROGRAMMED ONCE, BUT THAT WAS A LONG TIME AGO. THE PATIENT HAD TINGLING IN HER HANDS, FEET AND NECK. THE PATIENT HAD A TIA (TRANSIENT ISCHEMIC ATTACK) IN (B)(6) 2011 AND HCPS RAN A TEST (BRAIN / CAT SCAN) AND DISCOVERED THE PATIENT WAS HAVING COMPRESSION ON HER NERVES IN HER NECK AND HAD TO PERFORM EMERGENCY SURGERY TO REMOVE A DISC AND INSERT A PLATE TO HELP SO THEY COULD PREVENT POTENTIAL PARALYSIS. [NOTE: THERE IS NO ALLEGATION OR INDICATION THAT THE DEVICE PLAYED ANY ROLE IN THE TIA.] THE SURGERY WAS FOR SEPARATION. PATIENT STATES SHE WAS VERY UPSET BECAUSE SHE HAD BEEN COMPLAINING AND NO ONE UNDERSTOOD THAT IT HAD NOTHING TO DO WITH HER STIMULATION THAT ISN'T COVERING THE PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7427 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |