RESTORE ADVANCED
Report
- Report Number
- 3007566237-2013-00112
- Event Type
- Malfunction
- Date Received
- January 11, 2013
- Report Date
- October 31, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, FR
- Reporter Occupation
- OTHER
Narratives
(B)(4)
(B)(4).
(B)(4).
NOTE THAT PATIENT IDENTIFIER WAS NOT INCLUDED IN INITIAL REPORT. FIELD HAS BEEN UPDATED.
(B)(4).
(B)(4).
FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD "DETERIORATED" SINCE THE PREVIOUS CONSULTATION ON (B)(6) 2013. THE PATIENT WAS DESCRIBED TO HAVE A "STAB" PAIN ON THE PATH OF THE EXTENSION COMPONENT OF THE INS SYSTEM WHICH HAD INTENSIFIED EVEN WHEN THE INS BATTERY WAS IN A DISCHARGE STATE. FURTHER DETAILS INCLUDE THAT AS LONG AS THERE "WAS ENERGY" IN THE INS (OFF, AMPLITUDE 0) THE PATIENT FELT A BURNING AND ITCHING FROM THE WAIST TO THE TOES. THE PATIENT HAD RECHARGED THE INS ONE TIME SINCE (B)(6) 2013 BECAUSE IT WAS DISCHARGED AND, OF LAST TUESDAY ((B)(6) 2013) THE DEVICE WAS FULLY DISCHARGED. THE PHYSICIAN NOTED A SMALL MEDULLARY CONTUSION WITHOUT A HEMATOMA WAS OBSERVED DURING THE PLACEMENT OF THE LEAD ON (B)(6) 2012. IT WAS ALSO REPORTED THAT THE PATIENT HAD BEEN SUCCESSFULLY IMPLANTED IN THE PAST WITH BOTH PRIME CELL AND RECHARGE MODELS OF IMPLANTABLE NEUROSTIMULATORS (BOTH FROM THE SAME AND DIFFERENT MANUFACTURERS). THE PATIENT WAS SCHEDULED TO MEET WITH THE PHYSICIAN ON (B)(6) 2013. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION STATED THAT AFTER THE STIMULATION WAS TURNED OFF FOR THREE WEEKS, THE BURNING SENSATIONS IN THE LEGS AND IN THE ABDOMINAL AREA HAD "STRONGLY DECREASED." IT WAS ALSO STATED THAT THE CONSTRICTION OF HIS REAR THIGHS AND THE ABDOMINAL EDEMA HAVE DISAPPEARED. IMPEDANCE TESTING AND X-RAYS SHOWED NORMAL RESULTS. ON (B)(6) 2013, REPROGRAMMING AND TROUBLESHOOTING WERE ATTEMPTED WITH NO SUCCESS. WHEN STIMULATION WAS TURNED BACK ON, THE SYMPTOMS RETURNED. THE DEVICE WAS TURNED OFF AND THE PATIENT'S OUTCOME WAS REPORTED AS "PAINFUL."
IT WAS REPORTED THAT A PATIENT FELT BURNING SENSATIONS (NOT ELECTRICITY SENSATIONS) AROUND THE IMPLANTABLE NEUROSTIMULATOR (INS), EXTENSIONS, AND THROUGHOUT HIS ABDOMEN AND LOWER LIMBS. THE PATIENT ALSO EXPERIENCED MUSCLE SPASMS AT THE REAR OF HIS THIGHS. IT WAS STATED THAT ONE MONTH AGO SWELLING OF THE ABDOMEN AND LEGS APPEARED. IT WAS NOTED THAT ALL EXAMS PERFORMED HAD SEEMED "NORMAL". IMPEDANCES WERE REPORTED TO BE "NORMAL". THE INS WAS SWITCHED OFF FOR A PERIOD OF 3 WEEKS. THE SURGEON SUGGESTED THIS TO DETERMINE IF THE INS WAS INVOLVED IN THE BURNING SENSATION AND SWELLING. DEPENDING ON THE FEEDBACK FROM THE PATIENT, TROUBLESHOOTING WILL BE DONE IN THE FUTURE. IT WAS STATED THAT THERE WERE TESTS PERFORMED BUT THEY WERE NOT DESCRIBED. THE PATIENT STATUS WAS REPORTED AS ALIVE WITH NO INJURY OR ADVERSE EVENT. NO FURTHER INFORMATION WAS PROVIDED. IF MORE INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
ADDITIONAL INFORMATION REPORTED AN "ELECTRONIC EXPERT" WHO WAS NOT AFFILIATED WITH THE MANUFACTURER HAD ANALYZED THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) AND "DID NOT NOTICE ANY DYSFUNCTION." IT WAS NOTED THAT "JUST AFTER THE EXPLANTATION THE INSS (STILL CONNECTED TO THE EXTENSIONS) HAD BEEN CLEANED AND IMMERSED" FOR 15 MINUTES IN AN ENZYMATIC CLEANER/DISINFECTANT AND WAS THEN RINSED IN WATER. IT WAS THEN FURTHER NOTED HOWEVER THAT "8 MONTHS AFTER THE EXPLANTATION AND THE TESTS HE (THE "ELECTRONIC EXPERT") HAD DONE, HE NOTICED AN OXIDATION INTO THE INS CONNECTORS." THE "EXPERT" REPORTED THE "'OXIDATION' WAS NOT OBVIOUS" AND THAT IT WAS "MAYBE MICRO-ORGANISM GROWTH." IT WAS STATED "THERE SEEMED TO HAVE BEEN A LEAK ON THE RIGHT SIDE AT THE JOINT BETWEEN THE STAINLESS STEEL AND THE PLASTIC." THE "POINTS OF ENTRY OF THE ELECTRODE CONNECTORS WERE NOT SEALED" AND "A SPACE BETWEEN THE WIRE AND THE FLEXIBLE TUBING WAS VISIBLE." THE "EXPERT" ALSO REPORTED THAT "AT THE ENTRY POINT OF THE ELECTRODE'S WIRES, THERE WAS A RELATIVELY IMPORTANT DEPOSIT." IT WAS STATED THAT "ORANGE TRACES WERE VISIBLE ON THE LEFT SIDE (LESS THAN ON THE RIGHT)" AND THAT "THE ORANGE PARTS ALSO APPEARED ON THE PLASTIC." IT WAS NOTED THAT A NEW INS "DID NOT SHOW ANY VISIBLE ABNORMALITY" IN COMPARISON. THE "EXPERT" REPORTED THAT HE HAD TREATED BOTH INSS "IN THE SAME WAY" BY IMMERSING EACH IN A SALINE SOLUTION "FOR SEVERAL DAYS (MONTHS)" AND HAD THEN LEFT EACH "IN AN ENVELOPE FOR ABOUT FIFTEEN DAYS PRIOR TO THE EXAMINATION CONDUCTED ON (B)(6) 2014." THE "EXPERT" REPORTED "THE ORANGE 'SPOTS' WERE OBSERVED SHORTLY BEFORE THEY WERE PLACED IN THE ENVELOPE" AND "THERE DID NOT SEEM TO BE ANY CHANGE SINCE THE INITIAL OBSERVATION."
ADDITIONAL INFORMATION RECEIVED REPORTS THE PATIENT EXPERIENCED SHOCKING/JOLTING SENSATION AND STIMULATION IN THE WRONG LOCATION
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18199 | RESTORE ADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | IPG MFG SWITZERLAND | 37713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |