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dennis100
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« Reply #750 on: March 12, 2019, 03:11:35 AM »

Model Number 304-20
Device Problem High impedance
Event Date 06/19/2015
Event Type  Malfunction   
Event Description
Operatives notes from the (b)(6) 2015 surgery reported that the cause of the high impedance was determined to be incomplete pin insertion into the generator header. The pin was reinserted and the high impedance was resolved.
 
Event Description
It was reported that high lead impedance was observed upon checking the patient's device. The device was programmed off as a result. The patient had recently had generator replacement on (b)(6) 2015. The patient was referred for lead replacement surgery. The patient had surgery for the high impedance on (b)(6) 2015, and it was reported that the lead was found to be okay after being checked by the surgeon. Impedance was measured at 2825 ohms. As a result, the lead was not replaced. Attempts for additional, relevant information have been unsuccessful to date.
 
Event Description
Additional programming/diagnostic data was reviewed for the patient's device. There was an interrogation and system diagnostic test performed on (b)(6) 2015. Lead impedance was within normal limits (1932 ohms and 2008 ohms). A >25% change in impedance had occurred on (b)(6) 2015 with impedance from 1841 ohms to 2386 ohms. Review of decoder data available shows that the high impedance resolved on (b)(6) 2015; however, it is unknown how this happened. Additional information has been requested to determine the resolution. No additional relevant information has been received to date.
 
Event Description
It was reported that the company representative programmed the device back on on after the burr hole surgery on (b)(6) 2015 and did not observe any issue with the device. The patient had generator replacement on (b)(6) 2015 as captured in mfg report # 1644487-2015-06220. The lead was not replaced. Lead impedance was okay pre-operatively and post-operatively. The generator will not be returned for analysis per hospital policy. Additional programming and diagnostic data was assessed. It was observed that high impedance >10,000 ohms was detected initially on (b)(6) 2015, but then later on that day about an hour later, the lead impedance was within normal limits. No additional relevant information has been received to date.
 
Event Description
It was reported that lead impedance was within normal limits on the date of generator implant on (b)(6) 2015. The patient had scheduled surgery for the high impedance on (b)(6) 2015, and it was reported that the lead was found to be okay after being checked by the surgeon pre-operatively. Impedance was measured at 2825 ohms. As a result, the lead was not replaced and surgery reportedly did not occur. Review of the programming data revealed that the high impedance first occurred on (b)(6) 2015 to an impedance value greater than 10,000 ohms. The patient's generator battery was later showing 25% battery status, which is captured and reported in mfr report #: 1644487-2015-06220. No relevant information have been unsuccessful to date.

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dennis100
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« Reply #751 on: March 13, 2019, 01:06:20 AM »

Model Number 304-20
Device Problem High impedance
Event Date 08/14/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The patient underwent lead revision surgery on (b)(6) 2015. Attempts made for the product return of the lead were unsuccessful.
 
Event Description
The explanted lead was received on 01/06/2016. Analysis identified slice marks on the outer tubing, which most likely provided the leakage path for the dried remnants of what appeared to have been body fluids inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. However, it is known that the lead was not fully inserted into the generator during the initial implant surgery and was re-inserted, which was previously reported in mfr. Report #1644487-2011-03124. This most likely accounts for the setscrew marks that suggested the lead was not fully inserted into the generator. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. The company representative that attended the surgery verified that the lead pin was fully inserted into the generator when the high impedance was identified. Therefore, the most likely cause of the high impedance was due to a lead fracture in the electrode portion of the lead, which was not returned for analysis.
 
Event Description
It was reported fluid was observed by the surgeon in patient's leads during generator replacement surgery on (b)(6) 2015. Pre-op diagnostics showed 2547 ohms but the explanted generator was also mentioned to be pulse disabled due to battery depletion. During the surgery, high impedance was observed with the newly implanted device. The lead was not replaced and was planned to be revised at a future date. The lead is not believed to have been nicked during surgery. The pin insertion was checked and the pin was reported to be completely inserted. No known additional surgical interventions have occurred to date.

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dennis100
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« Reply #752 on: March 13, 2019, 01:08:14 AM »

Model Number 300-20
Device Problems Break; Calcified
Event Date 08/05/2015
Event Type  Malfunction   
Event Description
Product analysis for the returned lead was completed. It was noted that a portion of the lead assembly, including the electrodes, was not returned for analysis. White deposits were observed in various locations. The deposits were analyzed with energy dispersion spectroscopy which identified silicon, phosphorus, sodium, magnesium, and calcium. During visual analysis, three areas of the coil strands were identified as having the appearance of being melted, with re-solidified material. Based on obvious signs of mechanical damage on the coil surface, it is possible the thermally-damaged coil was exposed to a high temperature device such as a cauterizing tool during the explant of the lead. There were also two stress-related fractures noted on the lead. The stress fractures were due to rotational forces, which most likely completed the fracture with mechanical damage. A third region of the coil appeared to be stretched, kinked, and extended past the end of the cut/torn outer and inner silicon tubes. Determination could not be made if the end was cut. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the marked connector pin, indicating the lead had not been fully inserted into the cavity of the generator at one time. However, additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. The setscrew marks on the unmarked connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuity was identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the lead.
 
Event Description
Both the lead and the generator were received by the manufacturer. Product analysis for the returned vns generator showed the generator was noted to perform according to functional specifications. Analysis of the vns generator in the product analysis lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis for the lead is expected but has not been completed to date.
 
Event Description
It was reported the lead was found encapsulated by calcification at the site of the vns generator. When the generator was removed from the pocket, the lead was found to be damaged. Due to the lead damage, the lead was replaced. It was reported the vns device was tested during the pre-operative evaluation and no high impedance was noted. The suspect device is expected to be returned, but has not been received to date.
 
Manufacturer Narrative
Evaluation, results and conclusions; corrected data: this information was inadvertently left off of the supplemental #02 mfr. Report.

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dennis100
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« Reply #753 on: March 14, 2019, 04:18:21 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/04/2015
Event Type  Malfunction   
Event Description
It was reported that vns device diagnostics resulted in high impedance (dcdc converter 7). It was reported that the patient experienced an increase in seizures. It was reported that the device was turned off on (b)(6) 2015. X-rays were taken but not provided to the manufacturer to date for assessment. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. Further information was later received indicating that the patient underwent full replacement surgery on (b)(6) 2015. It was reported that device diagnostics with the new lead and generator were within normal limits. The explanted devices were not returned to the manufacturer for analysis.
 
Event Description
X-rays were provided to the manufacturer for review. The generator appears on the x-rays to be placed in upper chest in normal arrangement. The pin connector appears to be not fully inserted. But due to the quality and angle of the provided images, this could not be confirmed. The electrodes appeared to be placed in abnormal arrangement. The upper of the electrode was implanted very low in the neck, not as specified in labeling. Strain-relief bend and loop seemed to have been used. One tie-down was found holding the lead but it's unable to assess if they are placed as specified in labeling. A portion of lead behind the generator could not be assessed. No suspected lead break was found on the visible part of the lead. Further information received confirmed that the lead was implanted very low in the neck, as found on the provided x-rays, because as indicated by the surgeon: "this is his surgical technique".

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dennis100
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« Reply #754 on: March 15, 2019, 01:26:19 AM »

Model Number 302-20
Device Problem High impedance
Event Date 10/06/2015
Event Type  Malfunction   
Event Description
It was reported that vns device diagnostics resulted in high impedance. A dc-dc code 7 was observed during the normal mode and system mode diagnostic tests. No patient adverse events were reported. It was reported that the patient's device was turned off on (b)(6) 2015. No known surgical interventions have been performed to date. No additional relevant information has been received to date.
 
Event Description
Further information was received indicating that the patient underwent full revision surgery on (b)(6) 2015. It was reported that the lead was replaced due to lead break and the generator was prophylactically replaced. The patient's vns system was tested upon connection of the new lead to the existing generator and system diagnostics returned impedance results within normal limits. Return of the explanted lead to the manufacturer is expected but it has not been received to date. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Event Description
The explanted lead was returned to the manufacturer on (b)(6) 2015. Analysis is underway but it has not been completed to date.
 
Event Description
Analysis was completed on the returned lead portions and the reported allegations was confirmed. Note that the anchor tether, portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 417mm portion the end of the connector ring quadfilar coil appeared to be broken approximately 12mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having extensive pitting which prevented identification of the coil fracture type with residual material. The remaining broken coil strands was identified as being mechanically damaged (smooth surfaces) with pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed on the inner silicone tubing of the returned 14mm portion. Energy dispersion spectroscopy was performed on the deposit and identified the deposit as containing silicon, phosphorus, sodium and calcium. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified.

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dennis100
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« Reply #755 on: March 15, 2019, 01:27:49 AM »

Model Number 103
Device Problem High impedance
Event Date 09/23/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that high impedance was observed during the patient's initial implant surgery on (b)(6) 2015. After the new generator was implanted, diagnostics performed with the new generator and old lead out of pocket showed high impedance. The surgeon confirmed that the lead was not nicked during the surgery. The nerve, was irrigated but the diagnostics shill showed high impedance. The lead pin was reinserted into the generator and diagnostics still resulted in high impedance. The lead pin was removed and generator diagnostics with the lead resistor was performed resulting in normal results. The generator was connected to the old lead and high impedance persisted. Finally, the lead was replaced by the surgeon. Additional information was received that the high impedance was observed on system diagnostic test. Normal impedance was received once the lead was replaced. The suspect lead was received on 09/29/2015 due to lead discontinuity. Analysis is underway but has not yet been completed.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The lead was returned intact. The (+) white and (-) green electrode ribbons appeared to be stretched and the helices misshaped; indicating the lead assembly had been attempted to be used. The condition of the returned lead assembly is consistent with conditions that typically exist following an attempted implant procedure. No other obvious anomalies were noted except for the two half sets of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. Continuity checks of the returned lead assembly were performed with no discontinuities identified. Overall length and resistance measurements of the complete returned lead were determined to be in compliance with those defined in the manufacturing specifications. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portion of the device which may have contributed to the stated allegation of 'high impedance'. Incomplete insertion of the connector pin may have been a potential cause for the observed high impedance condition during the implant of this lead.

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dennis100
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« Reply #756 on: March 20, 2019, 10:38:44 AM »

Model Number 304-20
Device Problem Fracture
Event Date 10/14/2015
Event Type  Malfunction   
Event Description
It was reported that the patient had a fractured lead but underwent replacement on (b)(6)2015. It is unknown what specific devices were replaced (generator and/or lead). It is also currently unknown how the lead was determined to be fractured. No additional relevant information has been obtained to date.
 
Event Description
Additional information was received which clarified that both the generator and lead were explanted on (b)(6) 2015. No additional relevant information has been obtained to date.
 
Event Description
The explanted generator and lead were received on 01/29/2016. The reported "fracture of lead" allegation was not verified. Scanning electron microscopy images of the connector pin verified that pitting or electro-etching conditions have occurred on the connector pin. An energy dispersive spectrometry (eds) analysis performed on a sample of the reddish-brown deposits observed on the pin showed the presence of some elements present in stainless steel 316. The higher percentage of iron in this sample suggests oxidation may have occurred. An abraded opening of the outer tubing was observed in one location. Since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary could not 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 portions. The reported allegation of "high impedance" was not duplicated in the pa lab. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 036 volts, shows an ifi=no condition. In addition, signs of discoloration were also observed on the pulse generator case, which is consistent with the adhered remnants of dried body fluids following an explant process. No other surface abnormalities (such as sharp edges, header delamination, open pockets, decomposition, corrosion or voids) were noted on this device. Observations under pa lab bench microscope revealed pitting on the negative connector block and setscrew. Other than the noted visual anomalies, there were no performance or any other type of adverse conditions found with the pulse generator.

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« Reply #757 on: March 21, 2019, 12:41:28 AM »

Model Number 302-20
Event Date 10/06/2015
Event Type  Malfunction   
Event Description
It was reported that vns system implanted in the patient was tested and system diagnostics returned high impedance with dcdc code 7 and neos no. X-rays were taken and sent to the manufacturer for review. The generator appears to be placed under the right arm in an abnormal arrangement. The filter feed-through wires appears to be intact. The insertion of the lead-pin connector could not be fully assessed due to the orientation of the generator in the x-rays and the quality of images, it appears to be not fully inserted. The electrodes appeared to be placed in abnormal arrangement, not in the neck. A strain-relief bend and a loop were not used. Only one tie-down was found holding the upper lead body. Part of the lead appeared to be behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. It was reported by the physician that the device was not switched off yet. No known surgical interventions have occurred to date. No patient adverse events were reported to date.
 
Event Description
Further information was received from the facility, indicating that the patient underwent full replacement surgery on (b)(6) 2016. The lead was replaced due to lead discontinuity and the generator was prophylactically replaced. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. It was reported that the explanted devices will not be returned to the manufacturer as they were discarded. Therefore, no analysis results could be provided. No additional information was provided to date.

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« Reply #758 on: March 22, 2019, 01:42:47 AM »

Model Number 302-20
Device Problem High impedance
Event Date 12/03/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a vns patient underwent generator prophylactic replacement surgery, on (b)(6) 2015. During the replacement, high impedance was observed when the new generator was connected to the existing lead. The system diagnostic tests were performed prior to the surgery and the results were normal (dcdc 2). When the new generator was connected, diagnostic tests were performed and the dcdc was 7. A pin insertion issue or a generator issue were ruled out by performing several attempts; high impedance persisted. It was then decided to move forward with replacing the lead. It was reported that apparently patient had complained of neck pain in weeks leading up to surgery. The return of the explanted devices is expected but they have not been received to date. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Manufacturer Narrative
The previously submitted mdr inadvertently provided the wrong suspect device for the event.
 
Event Description
Further information was received indicating that the full replacement surgery took place on (b)(6) 2015, not on (b)(6) 2015 as previously reported. The explanted devices were returned to the manufacturer on (b)(6) 2016 for analysis. Analysis of the returned generator was completed. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis on the returned lead portions did not confirm the reported allegations. Note that portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils including the anchor tether and (+) white electrode were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the half set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portions of the device which may have contributed to the stated allegations. Note that since portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils including the anchor tether and (+) white electrode were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

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« Reply #759 on: March 22, 2019, 01:43:41 AM »

Model Number 302-20
Device Problems Break; High impedance; Lead
Event Date 12/07/2015
Event Type  Malfunction   
Event Description
It was reported that high impedance was found during pre-operative vns generator checks. It was noted the generator was replace prophylactically and lead pin re-insertions were attempted during surgery; however, lead impedance continued to go up. Therefore, the lead was replaced and the high impedance resolved. The surgeon noticed an obvious lead break with lead dissolution upon explant. The explanted lead was received by the manufacturer for analysis. Product analysis is expected but has not been completed to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Product analysis for the explanted lead was completed. It was noted that a portion of the lead assembly, including the electrodes, was not returned. Both stress induced fractures (fatigue fractures and rotational fractures) along with mechanical damage were found. Pitting was observed on the coil surface suggesting that stimulation was present for a certain period of time. Low magnification scanning electron microscopy analysis of the quadfilar coil shows characteristics typical of a lead discontinuity. Abraded openings were also found on the lead. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one point in time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest discontinuity in the returned portions of the device, which may have contributed to the stated allegations.
 
Manufacturer Narrative
Describe event or problem; corrected data: the information contained in this section was inadvertently left out of the supplemental #01 mfr. Report.
 
Event Description
Product analysis also determined that abraded openings in the inner and outer portions of the lead, along with the cut ends of the lead made during the explant process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubing in the tubing 1 section of the lead. In the second section of the lead that was returned, tubing 2, there was no obvious path for fluid ingress other than the cut ends that were made during the explant procedure.

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« Reply #760 on: March 22, 2019, 01:45:26 AM »

Model Number 304-20
Device Problem Battery Problem
Event Date 11/09/2015
Event Type  Malfunction   
Event Description
On (b)(6) 2015, it was reported through a product return request that the generator and lead were explanted in a planned generator replacement surgery for battery depletion. At the time, the reason for lead explant was unknown. Later communications that day established the surgeon was unable to separate the generator from the lead in surgery on (b)(6) 2015. The surgeon made efforts to manipulate the device, including completely removing the set screw as revealed by the operative report. The patient did not experience any adverse events as a result. The lead and generator have been returned to the manufacturer and are undergoing product analysis. The dhrs for both the generator and lead were reviewed and found all specifications met prior to distribution.
 
Event Description
Generator product analysis was completed on 01/05/2016, and lead product analysis was completed on 01/12/2016. During the visual analysis of the lead, the connector pin appeared to be bent. X-ray images of the products suggest the generator's canted spring was compressed, although it was also making a good electrical connection to the lead's connector ring. The pin and connector ring dimensions met lead final packaging specifications. During the visual analysis of the returned lead portions, deep canted spring indentations were observed on the connector ring surface. Continuity checks of the returned lead portions were performed and no discontinuities were identified. With the exception of the bent pin and deep spring indentations, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The bent lead pin was the likely cause of the removal difficulties and generator compressed canted spring condition. Since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The threads show damage toward the top of the generator connector block and were likely created by a tool during attempts to remove the lead in the explant surgery. The in-line cavity go gage passed insertion tests. Bench test leads were inserted and disconnected from the generator with no difficulties. All header dimensions were within specification. No additional adverse functional, mechanical, electrical, or visual issues were identified with the returned generator. A review of available programming history for the patient's generator showed no anomalies. Impedance values were within normal limits from the date of implant, (b)(6) 2012, until the last date of available history on (b)(6) 2015. A review of the dhr of the lead and generator revealed that both products passed all functional testing. As the functional testing requires pin insertion into a generator, the condition of the bent lead pin did not occur during manufacturing. Follow up communication with the implanting surgeon indicated that nothing usual was noted in the initial implant. Furthermore, good electrical contact was made as the device reported an impedance value within normal limits following pin insertion. No additional relevant information has been received to date.

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« Reply #761 on: March 22, 2019, 01:46:24 AM »

Model
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« Reply #762 on: March 24, 2019, 02:05:45 AM »

Model Number 304-20
Device Problem High impedance
Event Date 11/10/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was receiving an initial implant on (b)(6) 2015. During the surgery, high impedance was detected on the new vns system. The lead pin was disconnected and reconnected to the generator several times with additional diagnostic tests resulting in high impedance. A new lead was then opened and attached to the vagus nerve. When the new lead was connected to the generator, diagnostics again resulted in high impedance. The test resistor pin was then placed in the generator, but again diagnostics resulted in high impedance. A new generator was then opened and connected to the second lead. The subsequent diagnostic test resulted in a normal impedance value of 1,214 ohms. The surgery was then completed with these second devices implanted. The opened but unused generator and lead have not been received by the manufacturer to date. No additional relevant information has been obtained to date.
 
Event Description
Additional information was received that diagnostics were reportedly performed as opposed to just interrogations during the implant surgery where high impedance was detected. The explanted generator and lead were received by the manufacturer for analysis. Analysis of the suspect generator yielded no observed anomalies. The generator performed according to functional specifications. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Review of the ram/flash data downloaded from the generator shows the increased impedance was corrected; from a value of 12258 ohms to a value of 4015 ohms, and the time of change detection was (b)(6) 2015 (date of implant). This is indicative that diagnostics performed with the test resistor indeed resulted in normal diagnostic values. Analysis of the returned lead has not been completed to date. No additional relevant information has been received to date.
 
Event Description
Analysis of the returned lead was completed. A bent pin was identified in the lead connector. The identified bend of the connector pin may have been a contributing factor for the reported high lead impedance. However, the exact point in time of when this condition occurred is unknown. No other anomalies were identified in the returned lead. Programming history was reviewed for this patient and identified that only one system diagnostics test was completed during implant, which indeed resulted in high lead impedance. However, once the next lead was implanted, only interrogations were performed which continued to report the stored high lead impedance, without actually re-assessing the actual impedance. No additional relevant information has been received to date.

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« Reply #763 on: March 25, 2019, 01:15:24 AM »

Model Number 303-20
Device Problem High impedance
Event Date 12/23/2015
Event Type  Malfunction   
Event Description
It was reported that a patient, who was recently implanted with vns, experienced discomfort when the device was initially programmed on. Diagnostics showed that high impedance was present. The physician programmed the patient's generator off and ordered x-rays. The physician's office evaluated the chest x-rays that were taken on (b)(6) 2015, and they did not see anything that looked wrong. The x-rays were not available for livanova to evaluate. The patient had lead revision surgery on (b)(6) 2016. The surgeon did not test the lead impedance during surgery. He did not test the connection of the existing lead to the generator prior to replacing it. Therefore, it cannot be determined if there was incomplete lead pin insertion. The explanted lead is expected for return, but it has not been received to date.
 
Manufacturer Narrative
Udi of suspect device: (b)(4). Brand name, corrected date: initial report inadvertently reported the incorrect brand name of the suspect device. Model #, corrected data: initial report inadvertently reported the incorrect model of the suspect device.
 
Event Description
The patient felt pain in the left neck when her vns was turned on. The explanted lead was received on 02/02/2016. Analysis has not been completed to date.
 
Event Description
Analysis was completed on 03/01/2016. The entire lead was evaluated. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. The high impedance was most likely related to a lead pin insertion issue since the lead did not have any anomalies that would have caused the high impedance. Since the pain the patient felt was in the neck area, it would not have been related to the high impedance, which only would have caused painful stimulation at the generator site.

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« Reply #764 on: March 25, 2019, 01:16:06 AM »

Model Number 102R
Event Date 11/14/2013
Event Type  Malfunction   
Event Description
It was reported through a periodic review of the programming history database that high impedance was observed on the patient's device on (b)(6) 2013. The vns was programmed off on (b)(6) 2013 and found to be programmed on (b)(6) 2013, after impedance levels were re-checked and found within normal limits. It was later reported through operative notes the patient had generator replacement on (b)(6) 2013 and was doing well until approximated (b)(6) 2013, when the patient began having and increase in seizures. The vns was evaluated in clinic, and the high impedance was found. X-rays were taken and did not demonstrate any evidence of kinking or fracture. Due to the patient's increased seizure frequency and a concern for possible lead malfunction, vns exploration surgery was performed. The operative notes continued and stated the lead was freed from the vns pocked and was loosened and disconnected from the generator. The lead was thoroughly cleaned and dried. The area where the lead pin inserts into the generator header was also cleaned. The lead was then reinserted and secured in place using the generator setscrew. The device was re-implanted into the patient and diagnostic tests were performed. All tests were found to be within normal limits and functioning properly.

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« Reply #765 on: March 25, 2019, 01:17:05 AM »

Model Number 302-20
Device Problem High impedance
Event Date 07/01/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient's vns device was showing high lead impedance upon interrogation. It was reported that the patient experienced a breakthrough seizure in (b)(6) 2015, after previously having been seizure free. The physician assessed this increase in seizures to a loss of therapy from the high impedance. No known surgical interventions have occurred to date. No additional relevant information has been received to date.
 
Event Description
Additional information was received via clinic notes that this patient's vns impedance was reportedly normal during initial implant in 2011. No additional relevant information has been obtained to date.
 
Event Description
Patient underwent full revision surgery on (b)(6) 2016. The explanted devices were received on (b)(6) 2016. Analysis is underway but has not been completed.
 
Event Description
An analysis was performed on the returned lead portions and the reported allegations of fracture of leads was confirmed. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Visual analysis and scanning electron microscopy confirmed two broken coil strands as having extensive pitting. The area on a third broken coil strand was identified as being mechanically damaged with pitting which prevented identification of the coil fracture type. The area on the fourth broken coil strand was identified as having evidence of being worn to the point of fracture with flat spots on the coil surface. Pitting and flat spots were observed on the coil surface. Multiple areas on the broken coil strands had evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. An abraded inner tubing opening near the break location was also observed. What appeared to be white deposits were observed on the connector boot. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the half set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. In the (b)(4) lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

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« Reply #766 on: March 25, 2019, 01:18:01 AM »

Model Number 103
Event Date 01/01/2015
Event Type  Injury   
Event Description
It was reported that the patient was referred for surgery due to the generator migrating under the patient's armpit and causing pain. It was reported that the patient is developmentally delayed and patient manipulation is suspected. The physician reported that the generator replacement was being performed to preclude a serious injury. It was reported that the patient was experiencing breakthrough seizures and there is concern that the vns is not working as effectively as it was before which is why the generator will be replaced when the revision surgery occurs. No known surgical interventions have been performed to date.
 
Event Description
Pre-operative diagnostics performed prior to surgery for the generator migration identified high impedance (7335 ohms). Both the lead and generator were replaced. The generator and lead were received for analysis. Analysis of the lead was completed on 03/07/2016. Note that portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils, anchor tether and the (-) green electrode were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 230mm portion quadfilar coil 1 appeared to be broken approximately 21mm from the end of the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting with mechanical damage which prevented identification of the coil fracture type. Pitting and residual material were observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded open / torn area found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
Analysis of the generator was completed on 03/21/2016. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

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« Reply #767 on: March 29, 2019, 07:45:50 AM »

Model Number 300-20
Event Date 01/06/2016
Event Type  Malfunction   
Event Description
Clinic notes for a visit dated (b)(6) 2016 were received which observed high impedance on the patient¿s vns system. The patient¿s generator was previously replaced prophylactically on (b)(6) 2015. The patient¿s father estimates 10 partial seizures since the last visit. It was reported that the magnet rescue is no longer working where it usually works for the patient. Interrogation data showed 25 magnet activations had occurred. Side effects were denied. Vimpat was increased as it was stated the patient is not receiving adequate vns stimulation, however the patient was not satisfied with seizure control and side effects. No settings changes were made. The patient was referred for surgery. Follow-up to the company representative revealed that the implant case was covered and no high impedance was observed from that surgery. Review of the available programming history in the manufacturer¿s in-house database for the previously implanted generator revealed that diagnostics with the suspect lead were within normal limits on (b)(6) 2014. No additional information has been received to-date. No known surgery has occurred to-date.
 
Manufacturer Narrative
Event description, corrected data: information relevant to the suspect device was inadvertently not included on supplemental report #01.
 
Event Description
Product analysis was completed for the previous generator (b)(6) 2016. Review of the downloaded data revealed the last >25% change in impedance was on (b)(6) 2015, after the date of surgery on (b)(6) 2015. The lead impedance value prior to the change was within normal limits of 2241 ohms. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Follow-up to the physician's office revealed that at the (b)(6) 2015 replacement surgery, the generator was interrogated and found to have good impedance. It was not provided whether the high lead impedance was with the previous generator or the replacement generator.
 
Event Description
It was reported the patient had generator and lead replacement surgery. The explanted product is to be returned for complete product analysis, but has not been received to date.
 
Event Description
The explanted products were received 05/16/2016. Analysis was completed for the returned generator 06/07/2016. Results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings. The generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the generator performed according to functional specifications. The battery, measured 2. 995 volts during completion of the final electrical test and shows an intensified follow-up indicator=no condition. The downloaded data revealed that 5. 315% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the downloaded data from the generator indicated the last >25% change in impedance showed high impedance was present the date of explant (b)(6) 2016.
 
Event Description
Analysis was completed for the lead. Four sets of setscrew marks were seen on the marked connector pin providing evidence that proper contact between the setscrew and the connector pin existed at least once. Scanning electron microscopy images of the marked connector pin show that pitting or electro-etching conditions have occurred on the pin surface. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No discontinuities were identified within the returned lead portions. A tear opening was noted on the outer silicone tubing at approximately 3. 2cm and 17. 3cm from the end of the connector bifurcation. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the cut ends of the returned lead portions. A suture constricting the lead body was removed and abrasions due to its presence were noted at this location. Another abrasion most likely caused by the presence of a suture constricting the outer silicone tubing were noted. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

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« Reply #768 on: April 01, 2019, 12:33:19 AM »

Model Number 302-20
Event Date 04/01/2016
Event Type  Malfunction   
Event Description
It was reported that a patient had high impedance on a follow-up visit with the physician that occurred on (b)(6) 2016. The patient also reported not feeling stimulation and an increase in seizures. In (b)(6), the patient had experienced a hard fall while hiking and the increase in seizures and the change in perception of the stimulation occurred after the fall. The seizure rate increased from 2-3 per month to 9 seizures during the month of april, after the fall. X-rays were sent to manufacturer for review. Based on the images provided, the source of the reported high impedance could not be determined. There did not appear to be any obvious lead discontinuities in the portion of the lead that could be visualized; however, part of the lead was difficult to assess due to the quality of the images. The presence of a micro-fracture in the lead could not be ruled out. Review of the x-rays showed inadequate strain relief. The patient underwent full revision surgery on (b)(6) 2016. Post-op system diagnostics showed impedance values within normal limits. No additional relevant information has been provided to date.
 
Event Description
The generator and lead were received for analysis. Analysis of the lead was completed on 06/17/2016. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis what appeared to be pitting was observed on the connector pin surface. A definite cause for the pitting could not be determined based on the lead portion returned. The condition of the returned lead portion is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Analysis of the generator was completed on 06/21/2016. Review of the ram/flash data downloaded from the pulse generator shows a possible indication of increased impedance; the ¿diagvinitialprechange¿ value of 2085 ohms, the ¿diagvinitialpostchange¿ value of 19121 ohms, and the time of change detection (b)(6) 2016. It is likely that the generator was tested with a test resistor after explant to confirm high impedance within the lead. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no additional performance or any other type of adverse condition found with the pulse generator.

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« Reply #769 on: April 01, 2019, 12:34:16 AM »

Model Number 105
Event Date 02/11/2016
Event Type  Malfunction   
Manufacturer Narrative
Suspect device udi: (b)(4).
 
Event Description
High impedance was observed on (b)(6) 2016. The physician ran multiple diagnostic tests and received a >10000 ohms lead impedance warning message. The last time the patient was interrogated was on (b)(6) 2016 and the interrogation settings were reported as ok. And before that, the device was interrogated in her office on (b)(6) 2015 and the settings were ok. The physician indicated that the x-rays taken didn't show any obvious break. At that time, the physician was advised of exploratory surgery with consent need for full revision. The physician also confirmed that the patient is non-ambulatory so it is not likely due to a trauma event. A review of device history records for the generator and lead shows that no unresolved non-conformances were found.
 
Manufacturer Narrative
Suspect device udi: (b)(4).
 
Event Description
Patient was indicated for high impedance by neurologist and confirmed by the surgeon on (b)(6) 2016. X-ray was unavailable for case per the surgeon. During the surgery, the lead pin was unscrewed and reconnected using accessory pack. Surgeon made a comment that the lead pin felt loose. Two system diagnostics were ran that gave ok impedance. Surgeon opted for a prophylactic replacement of old generator with new generator. Two more system diagnostics were ran which indicated an ok impedance. The explanted generator was received on 04/11/2016. Analysis is underway but has not been completed to date.
 
Event Description
The pulse generator was explanted/returned due to prophylactic replacement. The reported allegation of pin not fully inserted was not duplicated in the (b)(4) laboratory. No obstructions were observed in the pulse generator header lead cavity or the connector blocks. In addition, the in-line cavity go gauge test passed and a bench in-line lead fully inserted into the pulse generator header, past the negative connector block (lab conditions). The reported allegation of high impedance was not duplicated in the (b)(4) laboratory. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 026 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

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« Reply #770 on: April 02, 2019, 12:25:44 AM »

Model Number 302-20
Event Date 04/19/2016
Event Type  Malfunction   
Event Description
Patient was referred for a full revision due to high impedance observed on normal mode diagnostics. A system diagnostic test was not performed and therefore the results are not available. No known surgical interventions have occurred to date.
 
Event Description
Patient underwent generator and lead replacement on (b)(6) 2016. During the surgery, the generator was replaced prophylactically first. The impedance with the old lead showed > 10,000 ohms, which confirmed that there was a lead discontinuity. The lead was also revised as a result. Impedance was within normal limits (2144 ohms) after the lead was replaced. The explanted generator and lead have not been received to date.
 
Event Description
The explanted devices were received on 07/29/2016. The device performed according to functional specifications of the current automated final test 102. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. The lead assembly was returned for analysis due to high impedance and lead fracture allegations. These allegations were not verified within the returned lead portions. Though difficult to state conclusively, the presence of a single setscrew mark at the end tip of the connector pin may be a contributing factor for the reported ¿high impedance¿ allegation. However the reason for this condition or the timing of when it may have occurred is unknown. Based on the location of the one of two sets of setscrew marks on the connector pin and scratches from the canted spring observed on the connector ring, it is believed that proper contact between the pulse generator ¿+¿ and ¿¿¿ terminals and the lead connector respective contact points (connector ring and connector pin) existed at one time. The lead connector was inserted completely in a pulse generator and no anomalies that could prevent proper insertion were identified. The electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

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« Reply #771 on: April 02, 2019, 12:26:33 AM »

Model Number 304-20
Device Problems Fracture; High impedance; Low impedance
Event Date 04/17/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
A physician reported to an international distributor that low lead impedance had been observed in a patient's vns system at a device follow-up. X-rays were taken and provided to the manufacturer for review. The x-rays showed no obvious anomalies but did reveal a possible sharp bend in the lead just above the generator and a possible pin insertion issue. The entire lead body could not be evaluated based on the x-ray images submitted. Submitted diagnostic data shows three low impedance (<600 ohms) measurements on (b)(6) 2016 along with 7 normal impedance measurements on that same date. A decrease in impedance is observed in the data over the last seven months. No patient adverse events have been reported. The physician intends to monitor the patient's condition and continue normal patient following. No specific intervention is planned and no surgical interventions have occurred to date.
 
Event Description
Follow-up on this event was provided indicating that the patient's impedance values were fluctuating. The patient had low impedance values that fluctuated to high impedance on (b)(6) 2016. Then, on (b)(6) 2016 the impedance values were all within normal limits. Then, the patient was visited on (b)(6) 2016 and the impedance values were high on multiple system diagnostic tests. The system diagnostic test on (b)(6) 2016 was also high. Then, the patient was seen on (b)(6) 2017 and the impedance was within normal limits. A new set of x-rays was provided for review and there was no indication of a sharp angle on this x-ray and the lead pin did not appear fully inserted into the connector block. No know surgical intervention has occurred to date.
 
Event Description
The patient was seen for a clinic visit on (b)(6) 2018, and high lead impedance was observed on her device. The distributor noted that the patient's device had previously shown both high and low lead impedance, but the impedance values had recently been within the normal range. Diagnostics performed at the clinic visit indicated an output current of only 0. 50 ma was being delivered, although the generator was programmed to 1. 5 ma. The distributor planned to send x-rays to the manufacturer for review. The x-rays were received by the manufacturer but have not been reviewed to date. The full programming history was reviewed for the patient's generator. Fluctuating impedance values were observed throughout a significant portion of the programming history, including the aforementioned low and high impedance, along with several internal impedance changes not observed in previous diagnostic tests. Low impedance was internally detected between multiple interrogations when impedance appeared to be normal in system diagnostic testing, indicating several quick fluctuations in impedance value. On (b)(6) 2017 impedance values were within the normal limits and remained so through multiple clinic visits until (b)(6) 2018; however, the high impedance was internally detected three days prior. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
The x-ray images were reviewed by the manufacturer. Due to the angle of the generator in the image, lead pin insertion into the generator could not be assessed. The filter feedthrough wires appeared intact, and the lead wire appeared intact at the lead pins. The lead was observed in the neck and chest. Due to the exclusion of the patient¿s upper neck from the provided images, the presence of strain relief could not be assessed in its entirety; however, a strain relief bend did appear to be present, and a strain relief loop appeared to be complete. Two tie-downs secured the lead at the strain relief bend, and one tie-down secured the lead at the strain relief loop. A portion of the lead appeared to be routed behind the generator. No gross fractures or lead discontinuities were observed in the provided images as visibility of the lead was lost near the collarbone. 3d-ct images were also included with the provided x-ray images. The presence and completeness of the lead strain relief was confirmed in the 3d-ct images. The portion of the lead routed behind the generator was also visible in the images, and a gross fracture was visualized in the portion of the lead that was not visible in the x-ray image. The thickness of the lead was minimal at the fracture location compared to the remainder of the lead body, signaling the potential for a short circuit condition to have existed. No additional relevant information has been received to date. No surgical intervention has occurred to date.

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« Reply #772 on: April 02, 2019, 12:27:16 AM »

Model Number 103
Event Date 03/28/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient developed an infection following generator re-implant after the previous generator was explanted due to an infection (mfr. Report # 1644487-2016-00270). The infection was present at the chest incision. The patient underwent generator and lead explant. Review of device manufacturing records for both the generator and lead confirmed sterilization of the devices prior to distribution.
 
Event Description
The generator and lead were received for analysis. Analysis of the generator was completed on 06/22/2016. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed on 06/23/2016. Note that the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the half set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified.

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« Reply #773 on: April 13, 2019, 04:04:37 AM »

Model Number 106
Event Date 08/01/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that high impedance was registered on the patient's vns system. The site performed a chest x-rays and reported to not show a visual anomaly with the lead. The device was disabled at that time and the patient was referred for surgery. The generator and lead dhrs were reviewed and found that all specifications met prior to distribution. The patient underwent surgery on (b)(6) 2016. At the start of the case, system diagnostics were performed that still showed high impedance. During the case, the test resistor was inserted into the generator, and a generator diagnostic showed expected values that were within normal limits. The lead was re-inserted and the impedance was measured to be within normal limits, 3718 ohms on one test and 3659 ohms on the second. The surgery was completed without replacing any products. The x-ray images taken prior to the case were reviewed by a company field representative, and the lead could not be visualized to be inserted past the generator connector block in the images. No additional pertinent information has been received to date.

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« Reply #774 on: April 13, 2019, 04:05:18 AM »

Model Number 303-20
Device Problem Difficult to Insert
Event Date 08/09/2016
Event Type  Malfunction   
Event Description
It was reported that during a first implant surgery, the surgeon had difficulties to insert the lead into the generator block. It was reported that during the surgery on (b)(6) 2016, the lead got stuck and it wouldn't completely go into the receptor head of the generator. The grub screw was lost out of the head and both lead and generator had to be replaced. It was reported that both products (generator and lead) are still at the hospital for examination to see if there is any defect. No further information was provided to date.
 
Manufacturer Narrative
Udi number: (b)(4).
 
Event Description
Further information was received from a nurse, indicating that the suspected device will be returned to the manufacturer for analysis. It was reported that when the reported issue was found, another device was implanted instead. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution.
 
Event Description
The suspected generator and lead were returned to the manufacturer on 09/26/2016. An analysis was completed on the returned lead portions and the reported "insertion difficulties" (lead section) allegation was not confirmed. The connector pin section including the small front o-ring and large o-rings was not returned. A portion of the connector boot was returned. The condition of the returned lead portions is consistent with conditions that typically exist following an attempted implant procedure. No obvious anomalies were noted. Continuity checks of the returned portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a product anomaly with the returned portions of the lead which may have contributed to the stated complaint. An analysis was completed on the returned generator and the reported allegation of "insertion difficulties" was not duplicated in the laboratory. No obstructions were observed in the pulse generator header lead cavity or the connector blocks. The in-line cavity go gauge test passed and a bench in-line lead fully inserted into the pulse generator header, past the negative connector block (lab conditions). The pulse generator header lead cavity (critical dimension 1) accepts a pin gauge of 0. 136 inches minus (limits 0. 137 +/- 0. 002). The pulse generator header lead cavity, critical dimension 1, meets specification. In addition, review of the ram/flash data downloaded from the pulse generator shows an impedance test was performed on the date of the attempted implant ((b)(6) 2016). The "time stamp impedance diagleadzhistory" results show: impedance value (ohms): 14240 - time stamp: (b)(6) 2016. This would suggest the lead pin was inserted into the pulse generator header. The reported allegation of "detachment of component(s) set screw" was not duplicated in the laboratory. The septum was cored and damaged on the underneath side. This suggests that the setscrew was extracted up into the septum. This may be the contributing factor for allegation of "detachment of component(s) set screw". The pulse generator performed according to functional specifications. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows an ifi=no condition. The data in the diagaccumconsumed memory locations revealed that 0. 767% of the battery had been consumed. There were no performance or any other type of adverse condition found with the pulse generator.
 
Event Description
An internal investigation of pin insertion difficulties identified two possible cause of pin insertion difficulties. First, it was determined that if any lead's large o-ring boot diameter was closer to the assembly specification of. 135 max, it may cause insertion difficulty. Second, model 303 lead assembly document allows for di water to be used for lubrication of the pin for insertion, if required, although it is not prescribed in labeling. It is suspected that the costa rica manufacturing facility potentially used di water to lubricate the pin when excessive force was needed. Review of the device history records found that the lead was manufactured in costa rica and therefore may have been subject to di water lubrication. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5893260
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« Reply #775 on: April 13, 2019, 04:06:43 AM »

Model Number 302-20
Event Date 07/26/2016
Event Type  Malfunction   
Event Description
It was reported that a patient had high impedance identified by his physician. The physician ran multiple system diagnostic tests that gave high impedance results. The patient had a full replacement on (b)(6) 2016. The lead and generator were both returned to the manufacturer and are both currently undergoing product analysis. After replacement, the impedance values were found to be within normal limits.
 
Manufacturer Narrative
Supplemental mdr #1 inadvertently did not include information regarding pitting that was identified in the lead analysis.
 
Event Description
The abraded openings identified in analysis of the lead most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. Pitting and corrosion were identified on the coil surface of the lead.
 
Event Description
Product analysis on the returned lead portions was completed on 08/29/2016. A portion of one of the inner silicone tubes and quadfilar coils past the electrode bifurcation was not returned for analysis and therefore an evaluation could not be performed on those sections of the lead. The lead was returned in 6 portions. Visual analysis of the lead identified two coil breaks on one portion of the returned quadfilar coil. Scanning electron microscopy was performed on the two coil breaks, with one having extensive pitting which prevented identification of the coil fracture type, and the other broken coil end having evidence of a stress induced fracture with mechanical damage. Visual analysis identified another coil break on another portion of the lead, proximal to the anchor tether. Scanning electron microscopy identified the area as having evidence of a stress induced fracture with mechanical damage and no pitting. The presence of metal pitting suggested that stimulation was present for a certain period of time. Abraded openings were identified on the outer and silicone tubing in multiple locations. A half set screw mark was identified on the connector pin, indicating the lead had not been fully inserted into the generator cavity at one time. An additional set of screw marks were found on the lead connector pin indicating that at one point in time a good mechanical and electrical connection was present. No other anomalies were identified in review of the returned lead. The explanted generator was also returned and had product analysis completed on 09/12/2016. The generator confirmed proper functionality in its ability to measure impedance values as well as in its ability to provide appropriate output current. No abnormalities were identified for the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5908690
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« Reply #776 on: April 14, 2019, 01:11:16 AM »

Model Number 302-20
Event Date 07/22/2016
Event Type  Malfunction   
Event Description
A call was received from a nurse on (b)(6) 2016. The nurse performed system diagnostics and high impedance and low output current was observed. The patient had a generator replacement (b)(6) 2015. A lateral and ap x-ray was suggested to evaluate the lead. No known trauma has occurred and the device has been left on for now. X-ray report was received but did not include any relevant information. No known surgical interventions have occurred to date.
 
Event Description
X-rays and x-ray report were received on (b)(6) 2016. Per the images received, it appears that the lead pin is inserted, but it is not completely inserted as the pin cannot be seen on the other side of the connector block. The lead wires at the connector pin and the feedthru wires appear to be intact. Of the lead portion assessed, there were no apparent sharp angles or gross fractures of the lead that could be seen in the images given. Patient underwent a full revision procedure on (b)(6) 2016. Several diagnostic tests were run in the or to confirm that it was not a lead pin insertion issue. Per the or supervisor, explanted devices are discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5880964
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« Reply #777 on: April 16, 2019, 12:41:06 AM »

Model Number 300-20
Event Date 09/13/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient had high impedance during a follow-up visit after their replacement surgery on (b)(6) 2016. It was also reported that high impedance occurred intra-operatively during the surgery, but was alleviated with proper pin insertion. The patient underwent full replacement on (b)(6) 2016 and post-op impedance within normal limits. The device was reportedly discarded immediately after surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5972760
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dennis100
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« Reply #778 on: April 21, 2019, 03:17:51 AM »

Model Number 103
Event Date 11/23/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that high impedance was observed on vns patient who was implanted on (b)(6) 2015. The high impedance has been seen in (b)(6) 2016 for the first time. The patient underwent a full revision on (b)(6) 2016 because they were not sure what caused the problem. Implant card received by the manufacturer reporting about the devices replacement. It was reported also that on the first implant date the lead impedance was ok. The review of the manufacturing records confirmed all tests passed for the generator and lead prior to the distribution. The explanted generator and lead were returned to the manufacturer where the analysis has been not completed to date.
 
Event Description
No programming history data review could be performed as no internal records found. The lead analysis showed that the reported high impedance was not verified within the returned lead portions. A single setscrew indentation was noted in the vicinity of the connector pin end tip suggesting that the lead connector was not inserted completely at one point in time. However, based on the location of the three additional sets of setscrew marks on the connector pin and scratches from the canted spring observed on the connector ring, it is believed that proper contact between the pulse generator ¿+¿ and ¿¿¿ terminals and the lead connector respective contact points (connector ring and connector pin) existed at least once. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions. The generator analysis showed that generator performed as intended, there were no performance or any other type of adverse conditions found with the returned generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6123881
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« Reply #779 on: April 24, 2019, 01:04:04 AM »

Model Number 302-20
Device Problems Fracture; Mechanical Problem
Event Date 12/07/2016
Event Type  Malfunction   
Event Description
Patient was scheduled for a prophylactic generator replacement on (b)(6) 2016 due to ifi - yes. Prior to the surgery, high impedance noted in three times and twice again in the or. The generator was replaced first and the lead was connected to the new m 106 generator. High impedance persisted and so the lead was revised. Impedance was within normal limits after the lead revision. The explanted devices have not been received to date.
 
Event Description
The explanted lead and generator is believed to be discarded.
 
Event Description
The explanted generator and lead were received. Analysis is underway but has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions and the reported allegation of fracture of lead(s) was not confirmed. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The abraded openings found in the outer and inner silicone tubing, slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. White deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except the half set of set screw marks observed near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional set screw marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the lab, there is no evidence to suggest discontinuities in the returned portions of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6198234&pc=LYJ
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