RESTORE ADVANCED
Report
- Report Number
- 3004209178-2013-11592
- Event Type
- Injury
- Date Received
- July 10, 2013
- Date of Event
- March 1, 2013
- Report Date
- February 19, 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
- TX, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377860, LOT# V013677, IMPLANTED: (B)(6) 2007: PRODUCT TYPE LEAD PRODUCT ID 3887-45, LOT# V015628, IMPLANTED: (B)(6) 2007: PRODUCT TYPE LEAD; PRODUCT ID 3887-45, LOT# V026003, IMPLANTED: (B)(6) 2007: PRODUCT TYPE LEAD; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007: PRODUCT TYPE EXTENSION. (B)(4).
ANALYSIS OF THE INS, SERIAL # (B)(4), FOUND NO ANOMALY. ANALYSIS OF THE LEAD, LOT # V013677, FOUND THE LEAD BODY HAD BEEN CUT THROUGH AND THE PRODUCT WAS SEGMENTED. ANALYSIS OF THE LEAD, LOT # V015628, FOUND THE LEAD BODY OUTER INSULATION HAD MELTED. IT WAS FURTHER FOUND THE ANCHOR IMPRESSIONS EXTENDED 6.9CM ALONG THE LENGTH OF THE LEAD INDICATING THE LEAD WAS SLIPPING THROUGH THE ANCHOR. ANALYSIS OF THE LEAD, LOT # V026003, FOUND THE LEAD BODY HAD BEEN CUT THROUGH AND THE PRODUCT WAS SEGMENTED. ANALYSIS OF THE EXTENSION, SERIAL # (B)(4), FOUND THE EXTENSION BODY HAD BEEN CUT THROUGH AND THE PRODUCT WAS SEGMENTED. IT WAS FURTHER FOUND THE #0 SETSCREW WAS NOT TIGHT TO THE EXTENSIONS. THERE WAS AN IMPRESSION ON THE #0 CONNECTOR OF THE EXTENSION THAT INDICATES THE SETSCREW HAD BEEN TIGHTENED PROPERLY. THE #8 SETSCREW WAS TIGHT TO THE LEAD. ANALYSIS OF ANCHOR #1, LOT/SERIAL # UNKNOWN, FOUND NO ANOMALY. ANALYSIS OF ANCHOR #2, LOT/SERIAL # UNKNOWN, FOUND THE ANCHOR HAD SEPARATED FROM THE LEAD. IT WAS FURTHER FOUND THE SILICONE PORTION OF THE ANCHOR WAS SEPARATED FROM THE TITANIUM INSERT.
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377860, LOT# V013677, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3887-45, LOT# V015628, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3887-45, LOT# V026003, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 377860, LOT# V013677, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3887-45, LOT# V015628, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3887-45, LOT# V026003, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3550-39, PRODUCT TYPE: ACCESSORY. PRODUCT ID 3550-39, PRODUCT TYPE: ACCESSORY. (B)(4).
(B)(4).
(B)(4).
(B)(4).
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THE PATIENT FELT A WARM SENSATION ¿IN AND AROUND¿ THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET DURING RECHARGING. WHEN THE PATIENT WOULD RECHARGE FOR ONE HOUR OR MORE THEY WOULD FEEL A BURNING SENSATION THAT RADIATED ¿INSIDE OUT.¿ IT WAS STATED TO HAVE FELT LIKE THE INS ITSELF WAS HEATING UP AND CAUSING THE BURNING SENSATION. AFTER RECHARGING, THE INS AREA WOULD ACHE FOR A FEW DAYS. THIS ISSUE WAS NOTED TO HAVE BEEN OCCURRING FOR THE PAST COUPLE MONTHS. THE PATIENT SAW THEIR DOCTOR AS OF THE DATE OF THE REPORT, BUT NO INS TESTING WAS DONE. BESIDES THE HEATING, THE INS WAS WORKING FINE OTHERWISE. IT WAS ADDED THE PATIENT HAD INCREASED BACK PAIN THAT BEGAN ABOUT TWO MONTHS PRIOR. CHANGING SETTINGS WITH THE PROGRAMMER DID NOT RESOLVE THE PAIN. WHEN RECHARGING, THE ANTENNA WAS PLACED DIRECTLY OVER THE SKIN. THE SKIN AROUND THE INS POCKET WAS NOT RED. INFORMATION RECEIVED A LITTLE MORE THAN TWO WEEKS LATER INDICATED THE BURNING SENSATION WOULD RADIATE ABOVE THE PATIENT¿S WAIST AFTER RECHARGING. NO FALLS, TRAUMAS, OR PROCEDURES WERE NOTED. IT WAS NOTED THAT A TEMPERATURE SCREEN WAS NEVER SEEN. THE PATIENT DID USE THE BELT DURING RECHARGING. IT WAS STATED THAT THE BURNING SENSATION COULD NOT BE REPRODUCED WITH PALPATION, WITH AND WITHOUT STIMULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WOULD BE RE-TRIALED THE DAY AFTER REPORT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS RE-TRIALED ON (B)(6) 2013 AND GOT GOOD BACK AND LEG COVERAGE.
FOLLOW UP INFORMATION REPORTED THAT MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE PATIENT WERE UNSUCCESSFUL (PHONE CALLS NOT RETURNED). TO THE KNOWLEDGE OF THE MANUFACTURER¿S REPRESENTATIVE, ALL WAS ¿OK¿. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
THE COMPANY REPRESENTATIVE CONFIRMED ON (B)(4) 2013 THAT THEY SPOKE TO THE PATIENT¿S PHYSICIAN AND HE DID NOT THINK THAT THE LEAD HAD MOVED AND HAS PLANNED TO RE-TRIAL THE PATIENT. BASIC REPROGRAMMING WAS ATTEMPTED AND IMPEDANCES WERE CHECKED. THE REPROGRAMMING EFFORT FEEDBACK WAS CONSISTENT WITH LEAD MIGRATION DOWNWARD AS SHE WAS ONLY RECEIVING LEG STIMULATION. SHE WAS NOT RECEIVING EFFECTIVE THERAPY WITH HER SPINAL INS.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD THE SURGERY FOR THE PERMANENT IMPLANT ON THE DAY OF REPORT.
IT WAS FURTHER REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) AND ALL THREE LEADS WERE EXPLANTED ON (B)(6) 2013. IT WAS NOTED THAT THERE WAS A LOSS OF THERAPY REPORTED AND AN IMPEDANCE CHECK SHOWED OUT OF RANGE.
IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE PATIENT EXPERIENCED BURNING PAIN AT THE POCKET SITE. IMPEDANCE MEASUREMENTS WERE DONE AND EVERYTHING WAS NORMAL 1354OHMS-2242OHMS, NOTHING INDICATED ANY OPEN CIRCUITS. THE BURNING OCCURRED DURING USE OF THE INS AS WELL AS WITH RECHARGING. IT WAS THOUGHT THAT THERE HAS TO BE SOME OPEN CIRCUITS THAT WERE NOT SHOWING UP. THE PATIENT HAS ONE EPIDURAL LEAD AND TWO SUBCUTANEOUS. IT WAS NOTED THAT SHE HAS INTERSTITIAL CYSTITIS. SHE WAS FEELING STIMULATION AS INTENDED BUT HAS A RADIATING BURNING PAIN, FROM WAIST DOWN TO LEGS, WITH CHARGING AND NORMAL USE. THE VOLTAGE WAS INCREASED TO 1.5V ON THE SUBCUTANEOUS LEADS 1-7. ALL IMPEDANCES WERE NORMAL DURING THIS RETEST.
THE COMPANY REPRESENTATIVE CONFIRMED THAT INTERVENTION WAS NOT TAKEN OR PLANNED. THE BURNING HAS IMPROVED 30%. THE AMPLITUDE WAS LOWERED. IT HELPED WITH THE TINGLES IN THE LEGS BUT IT HAD TO BE TURNED BACK UP TO HELP WITH THE PAIN.
ADDITIONAL INFORMATION RECEIVED REPORT THAT THE MANUFACTURER REPRESENTATIVE MET WITH PATIENT IN (B)(6) AND DID REPROGRAMMING WHICH PROVIDED GOOD RESULTS FOR THE PATIENT'S PAIN. THE PATIENT TEXT MANUFACTURER REPRESENTATIVE THE DAY BEFORE REPORTED EVENT. THE PATIENT WAS IN THE EMERGENCY ROOM DUE TO HAVING PAIN AND NOT GETTING STIMULATION COVERAGE. IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE MET WITH PATIENT THE DAY OF THE REPORTED EVENT AND THEY COULD NOT FIND PROGRAMMING TO COVER PAIN IN BACK AREA. IT WAS NOTED THAT STIMULATION WAS ALL IN PATIENT'S LEG NOW. IMPEDANCES WERE ALL WITHIN NORMAL LIMITS. X-RAY WAS TAKEN AND SHOWED LEADS HAD MIGRATED FROM T8 TO T10. IT WAS EXPLAINED TO THE PATIENT THAT THIS MOVEMENT WAS CONSISTENT WITH CHANGE IN STIMULATION SENSATION. THE PATIENT DENIES ANY FALLS/TRAUMA BUT IT WAS BELIEVED THAT THE PATIENT MAY BE A TENNIS PLAYER. IT WAS REPORTED OVERALL PATIENT WAS NOT GETTING ADEQUATE STIMULATION COVERAGE DUE TO LEAD MIGRATION AND THE PATIENT WAS SPEAKING TO THE HEALTHCARE PROVIDER ABOUT SURGICAL INTERVENTION. IT WAS ALSO REPORTED THAT THE PATIENT WAS HAVING DIFFICULTY RECHARGING. THE COUPLING WAS NOT AN ISSUE, BUT JUST THE INTERVAL OF RECHARGING. IT WAS NOTED THAT THE PATIENT WAS USING THERAPY WHILE RECHARGING.
IT WAS FURTHER REPORTED AFTER THE RE-TRIAL ON THE DAY OF REPORT, THE DOCTOR "DID NOT WANT TO IMPLANT ANOTHER DEVICE" SO THE PLAN IS TO REMOVE THE OLD SYSTEM AND REPLACE IT WITH A NEW SYSTEM WITH NEW LEAD PLACEMENT. IT WAS NOTED THE REVISION DATE WAS NOT KNOWN.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 316112 | RESTORE ADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00039 YR | Required Intervention |