RESTORE SENSOR
Report
- Report Number
- 3004209178-2013-10444
- Event Type
- Injury
- Date Received
- June 17, 2013
- Date of Event
- May 28, 2013
- Report Date
- May 28, 2013
- 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
- IA, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID: 74002 LOT# N203589, IMPLANTED: 2010 (B)(6), PRODUCT TYPE ADAPTER PRODUCT ID: 3550-29 LOT# N306791, IMPLANTED: 2013 (B)(6), PRODUCT TYPE ACCESSORY PRODUCT ID: 748951 LOT# SERIAL# (B)(4), IMPLANTED: 2003 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3998 LOT# LB5432, IMPLANTED: 2003 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 748951 LOT# SERIAL# (B)(4), IMPLANTED: 2003 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 74002, LOT# N203589, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE ADAPTER; PRODUCT ID 3550-29, LOT# N306791, IMPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY; PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT# LB5432, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION. (B)(4).
(B)(4).
ANALYSIS OF EXTENSION, SERIAL NUMBER (B)(4), FOUND THAT THE EXTENSION BODY INSULATION HAD A BREACHED DEPRESSION. ANALYSIS OF THE ADAPTER FOUND NO ANOMALY. ANALYSIS OF THE EXTENSION, SERIAL NUMBER (B)(4), FOUND NO ANOMALY.
(B)(4).
(B)(4).
(B)(4).
ADDITIONAL INFORMATION STATED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WAS 3.8 VOLTS ON (B)(6) 2013 AND THE PATIENT DID NOT USE THEIR STIMULATION OVER THE WEEKEND. ON (B)(6) 2013 IT WAS STATED THE INS VOLTAGE WAS AT 3.78 VOLTS WHICH WAS NOT CONCERNING. IT WAS NOTED THE RECHARGER WAS NOT AVAILABLE AND THE RECHARGING STATISTICS WERE NOT LOOKED AT. THE PATIENT STATED THEY HOLD THEIR RECHARGER ANTENNA TO THEIR INS TO GET COUPLING BECAUSE THE INS WAS ¿TIPPED SOME¿ AND THEY LOST COUPLING EASILY. IT WAS STATED THE PATIENT¿S BURNING SENSATION WAS IN THE SUPERIOR LATERAL PORTION OF THEIR INS IN THE BACK OF INS AREA AND THE SHOCKING OCCURRED IN THE SUPERIOR MEDIAL PART OF THE POCKET. IT WAS REPORTED IMPEDANCES WERE RUN WHILE THE PATIENT PUSHED ON THE POCKET AND EVERYTHING WAS WITHIN NORMAL RANGE. IT WAS NOTED THE PATIENT EXPERIENCED THE BURNING SENSATION WITH THE STIMULATION BOTH OFF AND ON. REPORTEDLY, THE DAY PRIOR TO REPORT WHEN STIMULATION WAS TURNED ON TO 6 VOLTS THE PATIENT¿S BURNING STARTED AND WHEN THEY TURNED STIMULATION OFF IT REMAINED FOR A BIT AND TOOK SOME TIME TO GO AWAY. IT WAS NOTED THAT NO SHOCKING OCCURRED DURING THIS VISIT AND THE PATIENT WAS VISIBLY UNCOMFORTABLE. IT WAS STATED A REVISION WAS PLANNED FOR (B)(6) 2013 TO REMOVE THE ADAPTOR AND POSSIBLY MAKE A LARGER POCKET. IT WAS LATER REPORTED, THERE WERE NO ABNORMALITIES SHOWN WITH THE DEVICE. IT WAS STATED ELECTRODE CHECKS WERE DONE WHICH SHOWED NO OBVIOUS INDICATION THE INTEGRITY OF THE SYSTEM WAS COMPROMISED. IT WAS ALSO STATED THE PATIENT FELT THE BURNING SENSATION COME ON AS THEY INCREASED THE STIMULATION FROM 0-6 VOLTS WHERE THEY GOT THERAPEUTIC EFFECTS BUT UNCOMFORTABLE SIDE EFFECTS. REVIEWING X-RAYS SHOWED THERE MAY BE INTEGRITY ISSUES WITH THE ADAPTOR AND EXTENSION BASED ON NON-MEDICAL JUDGMENT. IT WAS ALSO REPORTED, THE PATIENT WAITED 12 HOURS FOR THE BURNING SENSATION TO SUBSIDE AFTER STIMULATION WAS TURNED OFF. IT WAS NOTED THE DEVICE WAS NO LEAKING CURRENT. IT WAS STATED THE PATIENT HAD APPROPRIATE THERAPY ELSEWHERE AND STIMULATION IN THE CORRECT AREAS BUT BURNING IN THE POCKET ONLY. IT WAS LATER REPORTED THE PATIENT¿S REVISION SURGERY WAS SCHEDULED FOR THE DAY OF REPORT AND THEY PLANNED TO REPLACE THE EXTENSION, GET RID OF THE ADAPTOR AND KEEP THE INS. IT WAS LATER REPORTED, THE PATIENT¿S EXTENSIONS WERE REPLACED, THE ADAPTOR WAS REMOVED AND THE INS WAS MOVED. IT WAS NOTED A GENEROUS POCKET OF FLUID WAS FOUND WHERE THE ADAPTOR WAS. IT WAS STATED THE POCKET OF FLUID WAS DEEPER THAN THE POCKET WHERE THE INS WAS FOUND. IT WAS LATER REPORTED THE PATIENT WAS STILL DOING FINE.
ADDITIONAL INFORMATION WAS STATED THAT RECHARGING ¿TOOK THE PATIENT A LONG TIME.¿
IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON, THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. THREE EPISODES OF SHOCKING AT THE POCKET SITE HAD OCCURRED ON THE DAY OF THE REPORT WITH ONE OF THE EPISODES LASTING 10 MINUTES. IT WAS STATED THAT THERE WAS ONE TIME WHERE THE PATIENT FELT SHOCKING WHEN PUSHING ON INS (IMPLANTABLE NEUROSTIMULATOR) WITH IT BEING OFF. DURING THE REPORT, IT WAS IMPOSSIBLE TO REPRODUCE THIS AGAIN WITH THE INS OFF, BUT POSSIBLE WHEN THE INS WAS ON. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS COMPLAINT AND NO FALLS OR TRAUMA WERE REPORTED. IT WAS STATED THAT SHOCKING AT THE POCKET STARTED ON THE MORNING OF THE REPORT. IT WAS REPORTED THAT THE BATTERY HAD GRADUALLY SHIFTED IN POSITION AND THIS STARTED THREE WEEKS AFTER SURGERY. IT WAS STATED THAT MOVEMENT AND PALPATING CAUSED STIMULATION CHANGES. IMPEDANCES WERE CHECKED AND THEY WERE GOOD. THE SYSTEM WAS TURNED ON AND THE AMPLITUDE WAS SLOWLY INCREASED. ONCE THE PATIENT GOT A "LIGHT TINGLE," THE BATTERY WAS PALPATED, WHICH CAUSED DISCOMFORT THERE. IT WAS STATED THAT THE POCKED HAD NOT BEEN PALPATED TO SEE IF IT IS LOOSE. IMPEDANCES WERE TAKEN AGAIN BUT "XXXX" IMPEDANCE RESULTS WERE OBTAINED. X-RAY HAD BEEN TAKEN ON THE DAY OF THE REPORT AND IT WAS STATED THAT POCKET ADAPTOR COULD BE SEEN BEHIND THE INS PLUGGED INTO TOP PORT. IT WAS NOT KNOWN WHICH ORIENTATION THE X-RAY HAD BEEN TAKEN IN SO IT COULD NOT BE EVALUATED FOR FLIP. IT WAS POSSIBLE TO OBTAIN 8 COUPLING BOXES INITIALLY WHEN THE PATIENT RECHARGED AND THEN IT DROPPED TO 0 THE LAST TIME THE PATIENT RECHARGED. IMPEDANCES WERE TAKEN AGAIN DURING THE REPORT WHEN THE PATIENT WAS FEELING SHOCKING, BUT IMPEDANCES WERE STILL IN NORMAL RANGE. IT WAS STATED THAT THE PATIENT SO FAR HAD ONLY FELT SHOCKING ON PROGRAM A. IT WAS REPORTED THAT PRIOR TO THE REPORT THE IMPEDANCES WERE CHECKED AND RESULTS OF "XXX" WERE RECEIVED IN IMPEDANCES FOR ALL REFERENCE ELECTRODES AT 0.7V. RUNNING IMPEDANCES AT 3.0V RESOLVED THE ISSUE. IMPEDANCES WERE RUN DURING THE REPORT AND WERE IN RANGE OF 976-1291 OHMS. NINE DAYS LATER, IT WAS REPORTED THAT REPROGRAMMING HAD BEEN DONE, HOWEVER, THE SHOCKING OCCURRED AGAIN. SIX DAYS LATER, IT WAS REPORTED THAT THERE WAS SHOCKING IN THE POCKET WITH POSITIONAL CHANGES "OR JUST OUT OF THE BLUE." IT WAS STATED THAT THE PATIENT WAS GIVEN SEVERAL PROGRAMS TO TRY BUT THAT DID NOT FIX THE ISSUE. THE PATIENT HAD TWO PROGRAMS TO TRY AND FELT SHOCKING MORE WITH ONE PROGRAM THAN ANOTHER. IT WAS STATED THAT ADAPTIVE STIM WAS NOT ENABLED. THE PATIENT DID NOT FEEL SHOCKING AT LEAD/EXTENSION CONNECTION. IT WAS ALSO REPORTED THAT THERE WAS PAINFUL SHOCKING AND BURNING AT INS POCKET WITH STIMULATION ON OR OFF. IT WAS STATED THAT THE SHOCKING AND BURNING HAD GOTTEN WORSE WITH TIME AND WAS CHRONIC AT THE TIME OF THE REPORT. THE EVENT OR SYMPTOMS OCCURRED FOLLOWING A REPLACEMENT. IT WAS STATED THAT THE SHOCKING STARTED 1-2 MONTHS AFTER THE PATIENT HAD RECEIVED SENSOR INS. IT WAS STATED THAT SHOCKING WAS PAINFUL TO THE PATIENT. IT WAS STATED THAT IMPEDANCES WERE WITHIN NORMAL RANGE ON THE DAY OF THE REPORT. THE STIMULATION WAS OFF AS THE PATIENT FELT SHOCKING ALL THE TIME. AS OF THE DAY OF THE REPORT, PALPATION AND MOVEMENT DID NOT CHANGE THE SHOCKING SENSATION AT ALL. IT WAS STATED THAT THERE WERE NO X-RAYS DONE. NO PROBLEMS RECHARGING THE INS WERE REPORTED. IT WAS ALSO REPORTED THAT IMPEDANCE CHECKS HAD BEEN DONE BUT THE REPORTER WAS UNABLE TO REPLICATE PATIENT¿S EXPERIENCE WHILE IN HCP'S (HEALTHCARE PROFESSIONAL'S) OFFICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS LATER REPORTED THAT THE PATIENT RECOVERED WITHOUT SEQUELA AFTER DEVICE REMOVAL.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD A REVISION TWO YEARS PRIOR. ENGINEERS CAME DOWN TWO YEARS PRIOR WHEN THEY CHANGED OUT THINGS AND THEY FOUND THAT THE EXTENSION HAD A LEAK OF ENERGY SOMEWHERE IN THE EXTENSION. [REFERENCE MANUFACTURER REPORT #3004209178-2015-04436 WHICH PERTAINS TO THIS EVENT].
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272930 | RESTORE SENSOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00043 YR | Required Intervention |