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dennis100
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« Reply #810 on: June 14, 2019, 05:53:02 AM »

Model Number 103
Device Problem High impedance
Event Date 11/03/2017
Event Type  Malfunction   
Event Description
High impedance was observed for patient's device. X-rays were ordered and device was disabled. No known surgical intervention has occurred to date.
 
Manufacturer Narrative
(b)(6). Initial mdr reported the wrong patient identification details inadvertently.
 
Event Description
Additional details about the patient identification was received. The patient underwent surgery and it was reported that the lead pin had become loose. The surgeon reinserted and the high impedance resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7043768
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dennis100
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« Reply #811 on: June 15, 2019, 10:53:52 PM »

Model Number 106
Device Problem High impedance
Event Date 10/12/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Report received that a patient's vns presented with high impedance after system diagnostic testing was performed. The patient had a generator replacement about three weeks prior to the high impedance being found. The post-op impedance after this replacement was found to be good. The company representative present at the surgery recalled the lead pin being fully inserted. Clinic notes from the day high impedance was found indicated the physician and company representative asked the patient if any trauma occurred that may have caused the high impedance, however no response was provided. The same company representative later reported that the patient said no trauma had occurred. X-rays were reportedly taken and reviewed by the physician. He reportedly did not believe the images showed any conclusive evidence for the cause of high impedance because not all of the lead was visible. However, clinic notes from the physician stated "x-ray shows leads plugged in". These images were not reviewed by the manufacturer. No surgical intervention has occurred to date and no other relevant information has been provided.
 
Event Description
Further information was received that the patient returned to the or for the high lead impedance. Before replacing the lead, the surgeon pulled the pin out of the generator cavity, reinserted the pin, and claimed to have felt it sink in a millimeter deeper. Three lead impedance tests were performed and all were within normal limits. No products were replaced. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7009570
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dennis100
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« Reply #812 on: June 17, 2019, 04:07:31 AM »

Model Number 106
Device Problems High impedance; Difficult to Insert; Difficult to Remove
Event Date 12/05/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported by the tc that during a prophylactic generator replacement, two separate model 106 generators showed high impedance and pin insertion difficulties. Mfr report # 1644487-2017-05098 captures the first generator's high impedance and pin insertion difficulties, and this report captures the second generator's high impedance and pin insertion and removal difficulties. Reportedly, the surgeon connected the first model 106 and system diagnostics found high impedance. The lead was re-inserted, and the surgeon visually confirmed that the lead tip was past the connector block. He also confirmed that the set screw was fully tightened down. However, system diagnostics detected high impedance again. The surgeon then inserted the test resistor and performed generator diagnostics. Generator diagnostics also detected high impedance. The surgeon then reconnected the lead to the old 103 generator. System diagnostics on the old 103 generator were within normal limits. The surgeon then tried a second model 106 generator and experienced the same high impedance issue. The same troubleshooting used for the first generator were applied, but high impedance was still detected through both system diagnostics on the lead and generator diagnostics with the test resistor. The surgeon also reported that the lead didn't fit into the generators correctly; he had pin insertion difficulties with both generators and pin removal difficulties with the second generator. The surgeon said that he had released the air pressure with the screw, but this did not resolve the issue. A new model 103 generator was used and the issue resolved. The doctor looked at the openings of both the 103 and 106 and saw no difference. The manufacturer's device history records were reviewed; all of the generator's quality specifications were passed prior to distribution. The suspect product was received, but product analysis has not been completed on the generator to date. No further relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Product analysis was completed on the returned generators. Product analysis on the first generator (captured in the mfr. Report #1644487-2017-05098) was unable to duplicate either high impedance or pin insertion difficulties. With regards to the allegation of high impedance, various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. With regards to the insertion difficulties, no obstructions were observed in the header lead cavity or in the connector block. A bench lead was able to be completely inserted into the generator. In addition, the returned set screw bottom showed indention marks, indicating that a lead pin or in-line test resistor was at one time secured by the returned set screw. Product analysis on the second generator (captured in the current mfr. Report) was unable to duplicate either high impedance or pin insertion difficulties. With regards to the allegation of high impedance, various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. With regards to the insertion difficulties, no obstructions were observed in the header lead cavity or in the connector block. A bench lead was able to be completely inserted into the generator. Appropriate retention force was demonstrated the manufacturer's programming history database showed that system diagnostics were only performed twice on each generator on the date of surgery. No generator diagnostics were performed as originally reported. The manufacturer's device history records of the lead were reviewed. The lead passed final quality and functional tests prior to release. No further relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem. Corrected data: the following statement was inadvertently omitted from supplemental mdr 1 "product analysis on the second generator (captured in the current report) also found that the returned set screw bottom showed indention marks, indicating that a lead pin or in-line test resistor was at one time secured by the returned set screw. ".
 
Event Description
The company representative reported that he had seen the high impedance messages on his interrogation screen. No further relevant information has been received to date. Product analysis on the second generator (captured in current report) also found that the returned set screw bottom showed indention marks, indicating that a lead pin or in-line test resistor was at one time secured by the returned set screw.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7156368
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dennis100
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« Reply #813 on: June 18, 2019, 12:09:18 AM »

Model Number 105
Device Problem High impedance
Event Date 11/21/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
A company representative reported that during a replacement surgery for battery depletion, the patient¿s replacement device was programmed on and then high impedance was observed. It was reported that after several more tries high impedance was still observed. The company representative turned off the tablet and restarted it, programmed the generator back to 0. 0ma and then measured impedance again and the results were normal. The company representative stated that the attempts were systems diagnostics and were not interrogations. The device was programmed to 3. 5 ma when the high impedance message was provided. The lead was not replaced. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the company representative provided that the high impedance had been resolved during surgery as the result of pin re-insertion.
 
Manufacturer Narrative
Unique identifier (udi) #, corrected data: the udi for the suspect device was inadvertently not provided on follow-up report #1.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7124557
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dennis100
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« Reply #814 on: June 19, 2019, 03:54:24 AM »

Model Number 303-20
Device Problems High impedance; Difficult to Insert
Event Date 11/22/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the physician encountered a vns generator that was defective in the operating room. The device was not implanted because a connection did not work like the previous time. A company representative followed up with the facility and found that the defective device was actually a vns lead but no other additional relevant information has been received to date.
 
Event Description
It was reported that the surgeon failed to implant the vns generator due to the lead problem.
 
Event Description
It was reported that the surgeon had a problem connecting the lead and there was resistance at the first rim of the connector boot. The surgeon felt that there was too much rubber on the connector boot portion of the lead. A review of previous internal investigations that insertion difficulties could potentially be related to a number of factors. One potential cause is the that the diameter of the large o-ring boot is critical. All leads must meet a force requirement; however, it was found that the diameter of the large o-ring boot can be too high but within specification resulting in the leads requiring more force than the force maximum to fully insert the lead pin into the generator cavity. The device has not been returned to date so dimensional analysis could not be performed. Another potential contributing factor is the manufacturing work instruction allows for deionized water to be used as lubricant during manufacturing tests. It is known that the main manufacturing facility does not use this technique however it speculated that this technique may have been used at a secondary manufacturing facility. Manufacturing records confirmed the lead passed quality control inspection when it was manufactured at the secondary manufacturing facility. Based on the surgeon's report and manufacturing records it appears that the cause of the insertion difficulties could potentially be related to the events studied in the previous investigation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7138168
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dennis100
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« Reply #815 on: June 21, 2019, 12:11:03 AM »

Model Number 103
Device Problems Fluid Leak; High impedance
Event Date 12/21/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
During a prophylactic generator replacement surgery, high impedance was detected on the newly implanted generator despite impedance being okay prior to generator replacement. Pin re-insertion was performed multiple times, but the high impedance did not resolve. Generator diagnostics with the test resistor pin was within normal limits. In the portion of the lead that had been coiled behind the older generator, the surgeon believed that the lead had been kinked. When the lead was straightened, he saw an abraded opening in the lead with exposed wiring and fluid within the tubing. The attending company representative reported that the abraded opening was through the outer and inner tubing. The lead was replaced and system diagnostics on the new generator were within normal limits. The suspect product has not been received to date. No further relevant information has been received to date.
 
Event Description
It was reported that the suspect product was discarded. No further relevant information has been received to date.
 
Manufacturer Narrative

Event Description
The explanted lead and generator were received. Product analysis was completed on the returned generator. The generator performed according to functional specifications with no anomalies identified. Product analysis was completed on the returned lead. Only a portion of the lead was received. Two abraded openings with fluid leaks in the outer silicon tubing were identified, but did not penetrate into the inner tubing. High impedance was not duplicated/ on the lead pin, one set of setscrew marks were seen; this provides evidence that proper contact between the setscrew and the pin existed at least once. However, three single setscrew indentations were noted at the end tip of the connector pin; this suggests that the lead pin was not inserted completely at one point in time, which may have contributed to the high impedance observed. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Note that evaluation and resulting commentary cannot be performed on the portion of the lead not returned. The company representative said that she had checked to make sure that the lead was fully inserted. No further relevant information has been received to date.
 
Manufacturer Narrative
Suspect medical device, corrected data- the incorrect generator information was inadvertently reported in supplemental report #2. Device evaluated by mfr?, corrected data: it was inadvertently reported on supplemental report #2 that the suspect product was received for analysis. Device manufacture date, corrected data: the incorrect manufacturing date was inadvertently reported in supplemental report #2.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7194248
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dennis100
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« Reply #816 on: June 23, 2019, 03:39:11 AM »

Model Number 106
Device Problem High impedance
Event Date 11/03/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was detected on the patient's generator on (b)(6)2017. The patient's generator had been recently replaced on (b)(6) 2017 and impedance was okay on date of implant. The physician ordered x-rays and noted no visible sign of lead fracture. No known surgical intervention has occurred to date. No further relevant information has occurred to date.
 
Event Description
It was reported that at the patient's planned high impedance surgery, it was determined that the lead pin was not fully inserted into the generator. After re-inserting the lead pin, the high impedance resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7172823
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dennis100
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« Reply #817 on: June 25, 2019, 12:32:41 AM »

Model Number 302-20
Device Problem Fracture
Event Date 01/01/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was referred to surgery for a generator replacement due to battery depletion but high impedance was discovered pre-surgically with system diagnostics. The surgeon performed a full revision of lead and generator. Because the patient was an active individual, it was believed that the lead was broken during activity rather than a seizure. The explanted products have not been received to date.
 
Event Description
The explanted lead and generator were received for product analysis. Product analysis identified that the generator was partially depleted with the end of service indicator flagged. No anomalies in the returned generator were identified. Product analysis was completed on the returned lead. A portion of the lead was returned in one piece; however, the remaining portion of the lead, including the electrodes, were not returned. Product analysis identified a single set screw indentation at the end tip of the connector pin, which suggests that the lead pin was not inserted completely at one point in time and may have caused high impedance. However, a pair of set screw marks that shows good electromechanical connections existed at one time was also observed. This, along with the initial report that system diagnostics had been within normal limits many times prior to surgery, makes it unlikely that incomplete pin insertion is the cause of the high impedance. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7304798
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dennis100
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« Reply #818 on: June 26, 2019, 05:47:56 AM »

Model Number 104
Device Problem High impedance
Event Date 12/06/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the patient's vns has high impedance and they have been referred to for a full revision. The patient's seizures have increased and the physician believes this is due to the high impedance.
 
Event Description
The neurologist reported that the patient's high impedance was first observed on (b)(6) 2017. The patient's increase in seizures is above pre-vns levels. X-rays have been taken, but will not be provided to the manufacturer for review.
 
Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: initial report inadvertently did not include outcome of adverse event.
 
Event Description
The patient underwent surgery to resolve the high impedance. Per the company representative, lead pin reinsertion into the generator header resolved the high impedance, and system diagnostic tests were within the normal limits after surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7247229
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dennis100
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« Reply #819 on: June 27, 2019, 11:44:04 AM »

Model Number 106
Device Problem High impedance
Event Date 02/16/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a patient's device was interrogated and high impedance was observed. The patient's device was disabled and the patient was referred for a revision to address the high impedance. There were no traumatic events reported for the patient that could have contributed to the observed high impedance. No additional relevant information has been received to date. No surgical intervention is known to have occurred to date.
 
Event Description
The patient had a revision surgery to address the high impedance. During pre-op, high impedance was observed on the patient¿s device. During surgery, the lead pin was reinserted into the generator and the diagnostics were within normal limits. It was noted that the patient had previously fallen which could have contributed to the high impedance observed on the patient¿s device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7337357
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dennis100
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« Reply #820 on: June 28, 2019, 10:08:54 PM »

Model Number 106
Device Problems Detachment Of Device Component; High impedance
Event Date 01/18/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was observed on the patient's vns generator. The patient was referred to the surgeon for evaluation. Follow up with the surgeon's office revealed that it was unknown if there was any trauma or patient manipulation that could have contributed to the high impedance. It was stated that x-rays were performed to assess lead pin insertion. The patient was referred for vns lead replacement surgery. The x-rays have not been reviewed by the manufacturer to date. No relevant surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient underwent surgery to address the high impedance observed on the vns. It was stated that the surgeon thought it looked like the electrodes were not fully on the nerve. The surgeon removed the electrodes and then placed them back onto the nerve as well as relieved tension in the lead. Multiple diagnostics were performed during surgery and post-op and the impedance values were within normal limits.
 
Event Description
It was reported that high impedance was observed on the patient's vns again. The patient was referred for lead replacement surgery. Follow up with the tc revealed that the during surgery, the surgeon observed that the vns lead pin connector was loose in the generator header and appeared to not be properly secured. Lead pin insertion troubleshooting was performed and the high impedance was resolved. Several additional diagnostics were performed with the patient's neck in various positions to test the impedance values. The results were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7265105
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dennis100
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« Reply #821 on: July 02, 2019, 12:36:35 AM »

Model Number 1000
Device Problem High impedance
Event Date 04/19/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
A patient was referred for lead and generator replacement surgery less than 1 month after generator replacement surgery. The surgeon reported that high impedance was observed on the patient's device, and a warning message indicated that the programmed output current could not be delivered as a result. The patient had also experienced a change in seizure control no additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
The patient underwent surgery due to the high lead impedance. It was reported by a company representative that the high impedance resolved with lead pin reinsertion into the generator header. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7612054
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« Reply #822 on: July 02, 2019, 12:37:31 AM »

Model Number 303-20
Device Problems Corroded ; Fracture; Device Contamination with Body Fluid
Event Date 06/06/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that high lead impedance was observed which was caused by a fall (not seizure related) which knocked the patient's generator. It was stated that it appears from looking at a scan that the pin has come away from the generator. The patient underwent full revision surgery, and the explanted products have not been received by the manufacturer to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7645739
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« Reply #823 on: July 04, 2019, 12:06:08 AM »

Model Number 1000
Device Problems Fracture; Adverse Event Without Identified Device or Use Problem
Event Date 05/10/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that a patient was implanted in (b)(6) 2018 and his device was not turned on until recently due to scheduling issues. The patient was programmed to 0. 25ma. The patient returned today complaining of burning at the generator site. The patient was sent for x-rays, and the device was disabled. Ap and lateral x-rays of the neck and chest were available that displayed complete view of the neck and chest. Based on the images provided, the feedthrough wires appeared intact at the connector pins, and the generator was placed in the upper left chest, as expected. However, based on the angle of the image, the connector pin does not appear to be fully inserted past the connector block. The lead was observed in the patient¿s neck and was routed toward the patient¿s left chest. A strain relief bend and loop are present and placed per labeling. Two tie downs are present. Both tie downs appear to be securing the strain relief loop per labeling but no tie down appears to be securing the bend. No obvious fractures or sharp angles were found in the images. Note that a portion of the lead was routed behind the generator so it could not be assessed. Based on the images provided, the patient¿s painful stimulation may be related to incomplete lead pin insertion. Note that the presence of micro-fractures could not be ruled out. Patient was referred to surgery for consult. No additional or relevant information has been received to date.
 
Event Description
At the patient's follow-up visit, high impedance stated to have been seen on the device and the patient was scheduled for a lead pin reinsertion. Pre-op testing found high impedance. The surgeon attempted pin reinsertion and impedance was still high, so they tested the generator with a test resistor and diagnostics indicated ok at 4100 ohms. At this point, the surgeon was not comfortable with the high reading, so he decided to open a new generator. The new generator was connected to the lead and diagnostics indicated 5444 ohms. A test resistor was not used to test this new generator at this time. The surgeon decided it was probably the lead that was defective, and he performed a revision of the old lead. The old lead was extracted and a new lead was implanted. The new lead was connected to the new generator and impedance indicated 9000 ohms. A second test was run indicating 9000 ohms. The or representative stated that at this point in the surgery, he rebooted and double checked his programmer and reran the diagnostic test. Impedance still indicated 9000 ohms. This was likely incomplete pin insertion as well. The original generator was still present in the operating room, so the surgeon decided to insert the new lead into the original generator. Impedance showed 1878 ohms. The new generator was then tested with a test resistor, and impedance was 4074 ohms. The surgeon made the decision to implant the original generator with the new lead as long as diagnostics were consistently ok. Three more diagnostics were run and showed impedances of 6189 ohms, 1716 ohms, and finally 1689 ohms. The first high reading was due to pin insertion which was corrected. With this, the surgeon felt comfortable using the original generator with the new lead, and the patient was closed up. The explanted devices have not been received for analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7567346
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« Reply #824 on: July 04, 2019, 12:07:00 AM »

Model Number 303-20
Device Problems Fracture; Therapy Delivered to Incorrect Body Area ; Adverse Event Without Identified Device or Use Problem
Event Date 05/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was feeling "electrical jolts" and recurrent pain at the vns site. Clinic notes received for the referral indicate that patient has recurrent left chest pain most likely related to vns placement as well as on occasion "feeling electrical jolts" suggestive of vns dysfunction/malfunction. It was reported that the electrical jolt occurs with stimulation on occasion but not every single time of stimulation. There is no pattern on when it occurs or with certain specific body movements. Surgical exploratory surgery was planned in regard to probable replacement of vagal nerve stimulator in view of chest pain as well as "electrical jolts" to preclude a serious injury but has not occurred to date.
 
Event Description
An implant card was received for the patient's full revision surgery. The implant card indicated that the generator was at intensified follow-up (ifi) = no pre-operation, and that the replacement was for discomfort in the neck. As no malfunctions were noted, and it is known that impedance issues would trigger an error message warning upon interrogation, it is reasonable to assume there was no impedance issue noted. It was stated that at the surgery, the patient was feeling a sharp pain at his electrode site about 4 months prior to the surgery. The pain was associated with stimulation as it seemed to be occurring every 5 minutes, however the neurologist stated that the device was turned off for the past 6-8 weeks. The device diagnostics were checked. Upon running diagnostics, the patient grabbed his neck and began coughing. The neurologist ordered and x-ray of the lead site and had not seen anything abnormal. When settings were increased to 0. 25 ma output current, the patient stated not feeling any stimulation. Output currents were increased to normal mode 0. 5 ma and magnet mode 0. 75 ma; the patient grimaced slightly and said the pain was ok. When the magnet was swiped, the patient began coughing and stated the pain was too much. The device was disabled again, and it was decided the patient would undergo a full revision. The explanted devices were returned for analysis. No abnormalities were noted from the generator. Diagnostics and interrogations were performed with various loads. Communication, impedance, and current delivered were as expected for all tests performed. The output signal was monitored for over 24 hours and placed in a simulated body temperature environment. The generator performed as expected and according to functional specifications. The lead assembly was returned in four portions with one loose tie down. Slice marks were observed in the tubing and the tri-filar coil appeared to be cut in half. The slice mark appeared to have been made by a sharp object which may have occurred during the implant procedure, however this could not be confirmed. The lead assembly had dried remnants of likely body fluids inside the tubing. The slice mark found most likely provided the leakage path to the dried remnants of likely body fluids. With the exception of this slice mark, the conditions of the returned lead portions were consistent with those typically seen from explant procedures. No other obvious anomalies were noted other than a bend connector pin. The set screw marks found on the lead connector pin provided evidence that at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, and except for the cut negative coil, no discontinuities were identified. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7609529
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« Reply #825 on: July 05, 2019, 09:51:20 PM »

Model Number 304-20
Device Problem High impedance
Event Date 05/21/2019
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Patient underwent generator replacement on (b)(6) 2019 due to low battery. It was noted that impedance was ok after replacement. The patient then began to experience an increase in seizures and it was noted that the magnet was not effective. During a follow-up outpatient visit high impedance was observed. It was noted that an x-ray was checked and it appeared that the lead pin was possibly slightly disconnected. It was noted that the device was disabled. X-rays were received and reviewed for the patient. The generator was located in the patient¿s upper left chest. The connector pin cannot be seen coming through the second connector block and the end of the connector pin appears to be outside of the generator header cavity. This indicates that the pin has not been completely inserted per labeling. The filter feedthru were confirmed to be intact. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. There was a portion of the lead that was routed behind the generator, and the lead wires were unable to be assessed as intact at the connector pins due to image quality. No sharp angles or gross discontinuities were identified in the visible portion of the lead. Note that the presence of a micro-fracture and/or a lead discontinuity in the obscured portions of lead could not be ruled out. Further information was received that the cause of the magnet not working and the increase in seizures was the high impedance. The increase in seizures was noted to be below pre-vns baseline levels. In regards to intervention, it was noted that the stimulation had stopped due to the high impedance therefore the patient's dose of antiepileptic drugs was increased and the patient was under a "wait and see" approach. It was noted that the believed cause of the high impedance was either incomplete pin insertion or lead breakage due to any factor and that the patient. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8699463
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« Reply #826 on: July 26, 2019, 12:57:10 AM »

Model Number 1000
Device Problem High impedance
Event Date 01/03/2019
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during a new patient implant surgery, high impedance was found. It was reported that the surgeon had properly irrigated the nerve during the surgery and that the lead pin was reinserted but the high impedance persisted. The coils were removed from the lead and cut additional space of the nerve after which the coils were placed back on the nerve which did not resolve the high impedance. Generator diagnostics with the test resistor in the generator were within normal limits. The lead was then replaced with another lead of the same model and lead impedance was within normal limits. A review of device history records for both the generator and lead shows that no unresolved non-conformances were found. The devices met all specifications for release prior to distribution. The lead has been received by the manufacturer. Analysis is underway but has not been completed to date. No additional or relevant information has been received to date.
 
Event Description
Analysis was completed on the returned lead. Two sets of setscrew marks were seen on the connector pin at the end tip suggesting that the lead connector was not inserted completely at least once. The location of the scratches from the canted spring noted on the connector ring suggests that the lead connector was inserted completely at least once. However, the exact point in time of when this occurred is unknown. The lead connector was inserted in a representative pulse generator header and no anomalies that could prevent proper insertion were identified. Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead assembly. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8282799
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dennis100
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« Reply #827 on: July 27, 2019, 12:05:52 PM »

Model Number 105
Device Problem Energy Output Problem
Event Date 12/13/2018
Event Type  Malfunction   
Event Description
It was reported that the patient presented to the clinic due to an increase in seizures, which were attributed to the vns not being set to the settings of the previously implanted device. However, when the physician attempted to increase the settings to 2. 50 ma, it was stated that a low output current warning was observed whenever normal and magnet mode were above 2. 00 ma. The system and magnet diagnostics showed that impedances were within normal limits and the battery status indicator indicated that 75-100% of the battery capacity was remaining. The surgeon's, physician's, and company representative's tablet data were received and the patient's programming and diagnostics history was reviewed by the manufacturer. While the surgeon also reported a low output current on the date of implantation, an ohm's law calculation verified that it was expected that the device would not be able to deliver that programmed output current with the given lead impedance and normal device variation in impedance accuracy and maximum output voltage. However, at the follow up appointments, when the vns generator was unable to provide the programmed output current. After applying ohms law, it was expected that the device would be able to deliver that programmed output current with the given lead impedance and normal device variation in impedance accuracy and maximum output voltage. A review of device history records revealed that the generator passed quality control inspection prior to distribution. No additional relevant information has been received to date.
 
Event Description
The explanted products were received by the manufacturer. Lead product analysis was completed. The condition of the returned lead portions was consistent with those typically existing following explant. No obvious anomalies were identified beyond the setscrew marks near the end of the lead connector pin indicating that the lead had not been fully inserted in the generator cavity at one point. However, additional setscrew marks found on the pin provide evidence that a good mechanical and electrical connection was present at one point. No discontinuities were identified during continuity testing. There was no evidence to suggest an anomaly with the return portions of the lead. The generator is still pending product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8228780
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dennis100
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« Reply #828 on: July 27, 2019, 12:06:37 PM »

Model Number 302-30
Device Problems Corroded ; Fracture; High impedance; Device Contamination with Body Fluid
Event Date 01/18/2019
Event Type  Malfunction   
Event Description
Patient was referred for generator and possible lead replacement. The patient had experienced a fall had completely dislodged the patient's generator and broken the leads. High impedance was observed pre-operatively and was thought to be due to pin reinsertion. When the patient was opened for surgery, it was noted that the pin was no longer inserted in the generator. The generator was then replaced and high impedance was still observed. The surgeon proceeded with lead replacement thinking that the lead may have broken during the patient's fall. The explanted lead and generator were received by product analysis. Product analysis has not been completed to date. No other relevant information has been received to date. The reported generator migration (generator becoming dislodged) was captured in mfr. Report #1644487-2019-00378.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8378306
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dennis100
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« Reply #829 on: August 09, 2019, 10:02:30 PM »

Model Number 302-20
Device Problems Fracture; Mechanical Problem; Device Contamination with Body Fluid
Event Date 06/17/2019
Event Type  Malfunction   
Event Description
It was reported that the patient's lead was replaced due to high lead impedance. Pin reinsertion was attempted twice. The second time the pin was re-inserted, impedance was ok, but then went back to high when in the generator pocket. Nothing was obstructing the header. A test resistor used with the generator was within normal limits. The doctor saw condensation in the lead and proceeded with lead revision. The suspect product has not been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8830860
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dennis100
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« Reply #830 on: September 06, 2019, 09:42:03 PM »

Model Number 302-20
Device Problem Fracture
Event Date 07/23/2019
Event Type  Malfunction   
Event Description
Patient presented with low battery and high lead impedance and was referred for full revision (replacement of the lead and generator). Patient presented for surgery. Impedance was high and the generator was replaced. Impedance was high with the replacement generator. Pin re-insertion was performed and the high impedance resolved therefore the patient was closed. Impedance was checked in post operation and the lead impedance was high again. The patient was referred back for lead revision. No further surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8898067
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dennis100
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« Reply #831 on: October 11, 2019, 11:40:53 PM »

Device Problem High impedance
Event Date 08/12/2019
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on the patient's device within a year of generator implant. The lead was implanted >10 years. The surgeon said the patient had some hard falls which potentially could have resulted in trauma or manipulation of the lead. X-rays were received and reviewed by the manufacturer. Based on the scope of the image, the feedthrough wires were intact but per the scope of the image, the pin cannot be seen past the second connector block. However, it should be noted that the generator is at an angle which could be concealing the tip of the pin. The lead's strain relief was not per labeling, based on the quality of the image, the lead wire appeared to be intact at the connector pin. The lead was assessed for fractures and no gross fractures or discontinuities were noted. Based on the x-rays received, the cause for the high impedance cannot be determined, but since the pin could not be visualized past the 2nd connector block it¿s possible that incomplete pin insertion is the cause. The presence of a fracture or micro-fracture in the lead cannot be ruled out. No further relevant information has been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8971650
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dennis100
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« Reply #832 on: October 11, 2019, 11:41:34 PM »

Model Number 302-20
Device Problems High impedance; Device Contamination with Body Fluid
Event Date 07/01/2019
Event Type  Malfunction   
Event Description
It was reported by the sales representative that the patient was taken to surgery due to high impedance found. X-rays were performed and found the lead pin was not past the second connector block. During the revision surgery, system diagnostics was performed indicating there was high impedance with low output current being delivered. All output currents were programmed to off. During the procedure it was verified the pin was not inserted all the way, however after removed and re-inserted there was still high impedance. A test resistor was used on the generator and obtained a normal impedance. The surgeon then inspected the pocket and found there was fluid/blood inside the body of the lead and proceeded to cut the lead. Per clinic notes from the neurologist, the surgeon noted the sudden high lead impedance was found in clinic. The patient was reported to have been hit where the vns is implanted with a softball approximately during this time. Information was received that the hospital lost the explant as the connected portion of the lead was sent for cleaning and lost in the process. The patient has not received a replacement. It was indicated that the surgeon and the referring epileptologist agreed that the blunt trauma of the patient being hit with the softball most likely caused the lead/electrode damage. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8965719
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