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dennis100
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« on: September 27, 2018, 09:50:16 AM »

Model Number 303-20
Event Date 08/18/2011
Event Type  Malfunction  
Event Description
The generator and lead were returned to the manufacturer on (b)(4) 2011. Additional information received from the return product form indicated that the ''generator screw would not release lead after one trial tightening. '' product analysis on the generator has been completed. No mechanical anomalies were observed with the returned torque wrench or generator. The torque wrench functioned properly when tightening the setscrew on the generator. Visual inspection results revealed that the septum was damaged on the inside by the setscrew; small pieces of the septum were in the hex head socket of the setscrew. No anomalies were noted on the hex head socket of the setscrew. A test resistor was inserted into the lead cavity and the setscrew tightened and secured the test resistor with the returned torque wrench. No anomalies were noted on the hex head of the torque wrench. No surface abnormalities (such as sharp edges, header delamination, open pockets, decomposition, corrosion or voids) were noted on this device. Results of diagnostic testing indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
It was reported that during the patient's initial implant procedure, a lead and generator were opened and not used because the set screw broke intraoperatively. Attempts for additional information and product return have been unsuccessful to date.
 
Event Description
Additional information was received from the product analysis. When returned, the lead pin was still attached to the generator. Also, during the decontamination process, the pieces of septum which were observed inside the hex head socket of the setscrew may have been removed, so it is unknown if the pieces could have contributed to the inability for the setscrew to be loosened. Also, the damage to the septum was observed on both the slit side, most likely caused by the torque wrench, and the underside most likely caused by backing out the setscrew to make sure it wasn't binding on the lead tip - to allow removal. Product analysis on the lead was completed on (b)(4) 2011. During product analysis the connector pin was found to be bent. Identification of the reported bent pin may confirm this to be a contributing factor for the reported event; however, the exact point in time of when this occurred is unknown. The lead connector boot appears to have been torn and the lead coils appear to have been torn at this location as well. Also, the connector ring has noticeable scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The exact point in time of when this occurred is also unknown. Other than the above mentioned observations and typical wear and explant related observations, no additional anomalies were identified within the returned lead portions. Follow up was performed with the implanting surgeon regarding the bent pin. The surgeon indicated that the pin did not appear bent or misshapen prior to implant. He indicated that the setscrew would not reverse initially, however when it did, he then could not remove the pin. The device history record for the lead was also reviewed. It was confirmed that the lead passed all functional and visual inspections prior to shipment.
 
Manufacturer Narrative
While no device failure was identified during product analysis of the device, it is likely that user interface caused the damage to the septum.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2279016
« Last Edit: October 11, 2018, 06:11:27 AM by dennis100 » Logged
dennis100
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« Reply #1 on: September 27, 2018, 09:51:20 AM »

Model Number 302-20
Event Date 02/27/2013
Event Type  Malfunction   
Event Description
The patient had their lead replaced on (b)(6) 2013 and their explanted product has been returned for analysis. Analysis completion is pending.
 
Manufacturer Narrative
Analysis of programming history. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional prior to distribution. Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Event Description
Notes from the patient's (b)(6) 2013 surgery were received on (b)(4) 2013. The device was reportedly not functioning for several years. (this was clarified to mean the device was at end of service). In surgery, the generator was disconnected and a new unit was connected to the existing lead. Testing showed impedance: the device was rechecked and retested. Inspection of the lead showed a longitudinal linear separation in the plastic around the metallic wires. While the wires themselves were grossly intact and there was no side of disconnect or fracture, the sheath around the wires appeared to have been worn down and split in a linear distribution. The plastic itself appeared to have eroded away from the wires. The lead was not replaced at this time. The generator was sewn into place. Lead revision is still likely but has not taken place.
 
Event Description
The lead analysis was completed on (b)(4) 2013. Analysis of the lead showed that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Visual analysis of the returned 309 mm portion showed abraded openings on the outer and inner silicone tubing in some areas. Visual analysis found that the quadfilar coil one appeared to be burnt in half in the body area of the returned lead portion. Scanning electron microscopy was performed and identified the burnt area as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). Based on the obvious signs of mechanical damage on the coil surfaces, it is possible the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. During the visual analysis of the returned 309 mm portion quadfilar coil two appeared to be broken approximately 211 mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type and mechanical damage. During the visual analysis of the returned 309 mm portion quadfilar coil two appeared to be broken approximately 250 mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and no pitting. 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 and inner silicone tubing two and the torn ends observed on both of the inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. 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, potassium, sulphur 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. 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 portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
On (b)(6) /2013, it was reported that high impedance was seen during generator revision due to end of service. The surgeon performed a generator diagnostic on the newly implanted generator. The generator was then reconnected to the lead ensuring that the pin was past the connector block and fully inserted. Diagnostics again showed high impedance. The surgeon inspected the portion of the lead that was able to be visualized, and a break was seen with fluid in the tubing. The lead was not replaced at this time. No patient manipulation or trauma was suspected, no x-rays were taken, and the explanted generator was discarded. The new generator was not programmed on. The last known diagnostics indicated a system diagnostic with dcdc=2 approximately two years prior. The patient was lost to follow-up; however, the patient had been experiencing an increase in seizures six months prior (below baseline), and the resident generator could not be interrogated or programmed because it was at end of service. The patient could not feel normal mode or magnet mode stimulation. The patient's physician believed the increase was due to loss of therapy. A blc at this time indicated negative results. Lead revision is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2983386
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dennis100
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« Reply #2 on: September 27, 2018, 09:52:14 AM »

Model Number 102
Event Date 02/04/2013
Event Type  Malfunction   
Event Description
Reporter indicated that during initial vns implant surgery of a patient, the hex screwdriver did not "click" and appeared to "spin around" in the generator receptacle. An additional hex screwdriver was used with the same results. While removing the lead from the generator, the lead reportedly broke. A new vns lead and generator were used to complete the surgery, and an audible "click" was heard when using the screwdriver. The generator, lead and hex screwdrivers involved have been returned and are pending analysis. Analysis of the lead did not identify a fracture. During the visual analysis the connector boot / inner silicone tubes appeared to be torn in half approximately 3mm from the end of the 2nd o-ring (at the end of the connector ring) and the appearance of the connector boot / connector ring backfill interface area suggests there was partial detachment. With the exception of the torn connector boot, the condition of the returned lead portion is consistent with conditions that typically exist following an attempted implant procedure. 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 assembly were performed with no discontinuities identified. No coil breaks were found. On the findings in the product analysis lab, there is no evidence to suggest any device-related anomaly with the returned lead. Analysis of the generator and screwdrivers is pending.
 
Manufacturer Narrative
Device failure occurred, but this was likely due to user error; this did not cause or contribute to a serious injury or death.
 
Manufacturer Narrative

Event Description
Analysis of the hex screwdriver packaged with the generator, based on the dimensional analysis, confirmed the hex screwdriver met design requirements. There were no performance or any other type of adverse conditions found with the hex screwdriver. The decontamination process showed the pulse generator was received with the lead connected. The lead was observed to be secured with the setscrew and both (lead and setscrew) were easily removed from the pulse generator. Visual examination, performed at the pa test bench, showed tool marks on the pulse generator case and header. These tool marks are most likely associated with manipulation of the device during the explant procedure, as the observed markings are consistent with devices typically used in a surgical procedure (forceps, etc. ). The septum was not cored. No other surface abnormalities (such as sharp edges, header delamination, open pockets, decomposition, corrosion or voids) were noted on this device. The returned setscrew hex socket was observed to be stripped. No burred or stripped threads were observed on the returned setscrew or the negative connector block of the returned pulse generator. However, the flat area and striations observed at the starting thread of the returned setscrew, suggests the setscrew was partially down during lead insertion. The returned setscrew was mounted into the negative connector block of a bench generator with no difficulties. Due to the stripped setscrew hex socket, no attempt was made to set the setscrew. A bench lead inserted past the negative connector block of the retuned pulse generator and was secured with a bench setscrew, no difficulties observed (lab conditions). The set screw shows that the hex socket depth is 0. 050 inches minimum. The returned hex screwdriver shows that approximately 0. 030 inches of the hex shaft end was damaged, rounded (non-hex shaped). These measurements suggest that the hex screwdriver was not fully engaged into the setscrew hex socket. Analysis of the hex screwdriver in the accessory kit identified that approximately 0. 030 inches of the hex shaft end is damaged, rounded (non-hex shaped). Per the hex screwdriver specification, the acquired measurements (area not affected by damage) met design requirements.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2988259
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dennis100
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« Reply #3 on: September 27, 2018, 09:53:11 AM »

Model Number 302-20
Event Date 10/06/2011
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies causing high impedance. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported by the physician that the patient had high impedance on diagnostic testing. There was no known cause for the impedance issue. Further information in the patient's clinic notes stated the last known good diagnostics had been performed (b)(6) 2010. The patient was being referred for a revision surgery. Attempts for further information have been unsuccessful.
 
Event Description
On (b)(6) 2012, it was discovered that after the patient's full revision surgery, the lead impedance was within normal limits. Product analysis on the generator was completed on (b)(6) 2012. The generator performed according to functional specifications and there was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Product analysis of the lead was completed on (b)(6) 2012. The electrode array portion of the lead was not returned for analysis, therefore a full evaluation and commentary on the entire lead could not be made. Scanning electron microscopy image of the connector ring shows that pitting or electro-etching conditions have occurred on the ring. The exact reason for this condition is unknown. The lead connector has partial detachment at the ring/backfill interface. No adverse effect was identified on the device performance as a result of this condition. The outer silicone tubing was abraded open in multiple locations. The lead assembly had remnants of what appears to be dry body fluids inside the inner and outer silicone tubing. No obvious points of entrance were noted other than the end of the returned lead portion. Other than the mentioned observations and typical wear and explant related observations, no additional anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received on (b)(6) 2011, when it was discovered that the vns patient had a full revision surgery that day. The generator was replaced for prophylactic reasons and the leads were replaced due to high impedance. The nurse practitioner later reported that no x-rays had been taken. She also reported that no trauma or patient manipulation occurred that is believed to have caused or contributed to the high impedance. The patients settings are output=1. 5ma/on time=21sec/off time=1. 1min. The explanted lead and generator were returned to the manufacturer for product analysis on (b)(6) 2011, that has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2340410
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dennis100
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« Reply #4 on: September 27, 2018, 09:54:36 AM »

Model Number 302-20
Event Date 08/11/2011
Event Type  Malfunction   
Event Description
Additional information as received that the patient had a generator and lead replacement. The generator and lead were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received that product analysis was completed on the generator and lead. 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. Scanning electron microscopy images of the connector ring of the lead show that pitting or electro-etching conditions have occurred on the connector ring surface. The exact reason for this condition is unknown. 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. Other than the above mentioned observations and typical wear and explant related observations, no other 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 one time.
 
Event Description
It was reported that the patient had high impedance on both system and normal diagnostics. Per patient, the high impedance was actually found back in (b)(6) 2011. At the time, the physician did not turn patient's device off and made no plan for lead revision since patient's seizures were well-controlled. X-rays were also taken, but no obvious lead break was observed. Patient did not report any trauma/falls or manipulation. Again, the patient did not want to turn the device off so the physician lowered the output current to 1 ma. Physician will see the patient again in 3 to 4 weeks and may turn off device at that time and possibly refer patient for lead revision.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2457877
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dennis100
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« Reply #5 on: September 27, 2018, 09:55:32 AM »

Model Number 102
Event Date 03/13/2013
Event Type  Malfunction   
Event Description
Analysis of the vns generator and lead was completed. No obstructions were observed in the generator header lead cavity or connector blocks of the pulse generator. In addition, the in-line cavity go gauge test, designed to verify proper lead cavity dimensions in the header area, passed. A bench lead inserted completely past the negative connector block and was set/released with the returned setscrew (lab conditions). The bench test lead removed from the pulse generator header with no difficulties (lab conditions). In addition, the as received photos (prior to decontamination) of the returned pulse generator and lead show that the setscrew is in the down position (set), which may have been a contributing factor for the removal difficulties. 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. 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. The generator was still connected to the lead. Documented ¿as-received¿ condition provided by the decontamination technician notes that the generator setscrew was tightened onto the lead connector pin. During the visual analysis the connector boot / inner silicone tubes appeared to be torn in half at the end of the connector ring with the quadfilar coils stretched and kinked in between the two halves. The (+) white and (-) green electrode ribbons appeared to be stretched and the helices misshaped; indicating the lead assembly had been attempted to be used. What appeared to be remnants of dried body fluids were observed on the ribbons and helices. With the exception of the damaged connector boot, the condition of the returned lead assembly is consistent with conditions that typically exist following an attempted implant procedure. The resistance measurements taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead assembly were performed with no discontinuities identified. No coil breaks were found. Based on the findings in the product analysis lab, there is no evidence to suggest any device-related anomaly with the returned lead. The tightened setscrew may have contributed to the damaged connector boot.
 
Event Description
During implant surgery on (b)(6) 2013, a physician disconnected the lead and generator in order to tunnel lead. Even with several attempts to unlock the screw (visible via dome of silicon plug in generator block) he was finally not able to disconnect. 'power' was used which disrupted the lead: the generator was still connected to the lead. The lead and generator were both explanted, and a back-up system was implanted. Clarification was received that several attempts to unscrew were made, and screwdriver worked well. Upon disconnection of the generator with the lead, a small disconnect field was seen in the connection point; therefore a new generator and lead were implanted. The surgeon could already see the silicon seal come up (dome). The lead and generator were returned on (b)(6) 2013 and are pending product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3040354
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« Reply #6 on: September 27, 2018, 09:56:26 AM »

Model Number ASKU
Event Date 10/12/2011
Event Type  Malfunction   
Event Description
Product analysis of the explanted lead was completed on (b)(6) 2012. During the visual analysis of the returned 151 mm portion the ends of the marked and unmarked quadfilar coils appeared to be broken. Scanning electron microscopy was performed and identified the area on both quadfilar coils as being mechanically damaged which prevented identification of the coil fracture type with pitting on the marked quadfilar coil break area. 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 what appeared to be remnants of dried body fluids / tissue and white deposits found 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. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found 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 other discontinuities were identified. Note that since the marked connector boot, and a large portion of the lead assembly (body) including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
Additional information received revealed that the patient underwent full revision surgery in which the lead and generator were explanted and replaced. The explanted lead was discarded and will not be returned for analysis. Good faith attempts to obtain the explanted generator are in process.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted lead and generator have been returned to the manufacturer and device evaluation of the explanted generator has been completed. The generator performed according to functional specifications and there was no abnormal performance or any other type of adverse conditions found. Product analysis of the explanted lead has not been completed at this time.
 
Event Description
It was reported that during a prophylactic generator revision surgery, a lead break was identified and the surgery was cancelled as the patient would need a full revision. Follow up with the site revealed that x-rays were not taken prior to surgery and at the time of surgery, a dcdc of 7 was obtained (unknown which mode). No device diagnostics were performed prior to surgery per the physician however the patient was not reporting any issues to the physician which would indicate there was an issue with the lead. Revision surgery to address the high lead impedance will likely occur but has not to date.
 
Manufacturer Narrative
Describe event or problem, corrected data - previous report stated that the lead was discarded however it was not. The information has been corrected on this report. Conclusions, corrected data - previous report stated that the lead was discarded however it was not. The information has been corrected on this report.

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« Reply #7 on: September 27, 2018, 09:58:17 AM »

Model Number 105
Event Date 01/02/2015
Event Type  Malfunction   
Event Description
The generator was returned for analysis on 05/07/2015, and is in progress. The lead assembly was returned for analysis and was completed on 05/22/2015. The connector ring has what appears to be pitting. Scanning electron microscopy images of the connector ring verified that pitting or electro-etching conditions have occurred on the connector¿s ring surface. 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 connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. 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.
 
Event Description
It was reported that the patient's generator and a portion of the lead were explanted on (b)(6) 2015 due to the patient no longer wanting vns. The explanted devices have not been received to date.
 
Manufacturer Narrative

Event Description
It was reported that the patient started having pain in the left arm and neck that was bad enough for him to go to the emergency room on (b)(6) 2015. The patient¿s vns was then disabled and an x-ray taken to ensure that the lead had not been damaged. Once disabled, the pain initially felt a little better, but the shocking feeling continued after the device was turned off and still had some shocking sensations for the next 24-36 hours. The lead impedance was noted to have shown ¿ok¿ at the patient¿s appointment on (b)(6) 2015 and the patient was turned back on to the lowest possible settings without issue. When asked whether any trauma may have occurred to the lead, the patient admitted to being under the influence of marijuana and that he seemed to ¿loose time¿ and when he came to he was standing in his garage. A copy of the patient¿s x-ray review was received and it was noted that the generator was unable to be disabled with the magnet. The patient later stated that he woke up one day after some seizures and he started to feel really hard stimulations (almost euphorically). Patient said it gave him a good feeling and he was even having conversations with dead people. This went on for 2 days and the hard stimulations were, so overwhelming for him that he went to the emergency room. While he was in the waiting room, he started pushing on his device in his chest and then heard a pop. After that everything went back to normal. System diagnostics were performed on the patient's device again and everything was normal. The patient was referred to a surgeon. The patient reported that he attributes his hallucination and continuous stimulation to the vns. It was noted that the patient¿s device was disabled.
 
Event Description
Analysis was completed for the pulse generator on 06/10/2015. The septum was not returned and no evidence of body fluids was observed in the header septum cavity. The device output signal was monitored for more than 24 hours, 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. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative

Event Description
It was later reported on (b)(6) 2015 that the patient was referred for explant surgery. Although surgery is likely, it has not occurred to date. The surgeon and the neurologist think that the patient is having mental issues that are causing the patient¿s problems, not the vns device. There have been multiple attempts to send the patient to psychology but the patient will not go. The patient is convinced the device is broken and wants a new one once his beliefs that the device is broken are confirmed, but the neurologist has concerns that this issue will be a recurrent one, as he believes the issue is psychological in nature, and therefore feels an explant is best.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4501232
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« Reply #8 on: September 27, 2018, 10:01:12 AM »

Model Number 102
Event Date 08/25/2011
Event Type  Injury   
Event Description
On (b)(6) 2012, additional information was received when the surgeon requested a copy of the product analysis results for the generator as he said the generator looked like it "might have leaked".
 
Manufacturer Narrative
There were observed corrosion/dried fluids and pitting conditions in the negative connector block and setscrew that were most likely related to the observed fluid ingress of the lead that was returned with this pulse generator. In the product analysis 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. Other than the visual observation of the header area, there were no performance or any other type of adverse conditions found with the pulse generator. Product analysis on the lead has not yet been completed.
 
Event Description
On december 6, 2011 additional information was received from the surgeon. The surgeon has no evidence that there was any patient manipulation that could have caused the high impedance or infection. No x-rays were taken. The surgeon stated that cultures were taken during surgery and both aerobic and anaerobic cultures were negative. The surgeon believes that the patient's events are directly related to the vns. He stated that the patient developed an increased seizure frequency in 2009 and a decision was made to replace the vns generator. When the new generator was turned on, the patient experienced significant pain and has had vocal cord paralysis since that point in time, approximately (b)(6) 2009. The lead was then replaced. The patient's vocal cord paralysis had not recovered by (b)(6) 2010 and she underwent operative nerve transposition to help with the vocal weakness. The patient was seen in (b)(6) 2011 with pain at the generator site. The patient had stated that she had been experiencing pain for several months prior and the surgeon stated that there was necrotic-appearing tissue at the incision site itself. The surgeon said he was concerned that there was a possible infection, but there was not purulent material at the time of surgery. The surgeon instead said there was very unusual appearing changes to the tissue surrounding the device, and the device itself had a hard metallic build up around it. The surgeon stated that therefore, the device was removed to prevent further injury. The surgeon did not say whether he was aware that the patient had high impedance since (b)(6) 2010 and whether or not the patient's device had been disabled.
 
Event Description
On (b)(6) 2011, a vns implanting neurosurgeon reported that the after the patient's generator was replaced in (b)(6) 2009, the patient was experiencing vocal cord paralysis where her left vocal cord did not move and had to have a re-innervation procedure. The patient was seen again as she developed what looked like a burn or fungating mass over the generator site. The surgeon removed the generator on (b)(6) 2011 and he reported that it had appeared to have leaked into the pocket; there was metal and scar tissue on histology and the device looked like a rusted battery. Clinic notes from the surgeon were also received. The notes dated (b)(6) 2011 revealed that the patient was experiencing worsening pain at the generator pocket site and had gone to the hospital and been evaluated for any cardiac disease. No cardiac disease was found. She started using a heating pad over the device and she reported that she developed significant blistering at the incision site of the generator and that this has been slowly improving. The device has become more prominent and more painful over the last few weeks however. The surgeon reported that the patient's skin is black and convoluted over the patient's generator incision scar. The device is easily palpable and somewhat mobile. He stated that the patient has likely a burn with some necrosis of the skin at the generator site. It also seems that she may be developing an infection at the generator site and that it should be removed. The surgeon said the patient's seizure control is now much worse without the vns functioning. The operative report from the date of explant, (b)(6) 2011, was also received by the surgeon. The report reveals that the patient had an existing 5cm linear skin incision from the implant of the generator and that a central area of this had turned black and widened to about 0. 5 cm in size. Therefore, an incision was performed to ellipse out the prior scar. The subcutaneous fat was found to be relatively normal in appearance; however, a capsule was encountered with significant fluid and samples were taken for cultures. The capsule was relatively black in color and there appeared to be a wall of possible hemosiderin-stained tissue, several millimeters thick, all within the generator pocket. The surgeon reported that the color of the titanium close to the header of the generator was altered and pictures were taken of it. The surgeon also stated that there was also a collection of very hard black porous material intimately attached to the device. The generator was explanted and the skin biopsy was sent for pathological evaluation. The generator pocket was then copiously irrigated and all of the black material within the scar capsule was removed mechanically. The wound was then closed. The patient's programming history was reviewed in the manufacturer's database which revealed that high impedance was detected on (b)(6) 2010 with a system diagnostics test and normal mode diagnostics test showing results of output=limit/lead impedance =high/dcdc=7/eri=no. The patient was disabled that day to output =0ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=3min/magnet output=0ma/magnet pulse width=500usec/magnet on time=60sec. The manufacturer's consultant reported that she obtained the explanted generator from the surgeon on (b)(6) 2011 and will be sending it back to the manufacturer for product analysis. It has not yet been received by the manufacturer to date. When additional information is received, it will be reported.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2011 when product analysis was completed on the explanted lead. A large portion of 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 connector pin quadfilar coil appeared to be broken approximately 213mm from the end of the connector boot. The area was identified as being thin which prevented identification of the coil fracture type with evidence of electro-etching, pitting and residual material on the surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Discoloration was observed inside the majority of the outer silicone tubing. Discoloration was observed throughout the inside of the connector pin inner silicone tubing and on the quadfilar coil. What appeared to be pieces of inner silicone tubing were observed inside the outer silicone tubing. The tubing discoloration suggests that fluid was present in the tubing at some point in time. Based on the returned lead portion, the initial location of fluid ingress into the tubing cannot be determined. With the exception of the identified discontinuity, pitting, and the discoloration observed, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure; no other obvious issues 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. Additional information has been requested from the surgeon but no further information has been received to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
Additional information was received on (b)(6) 2011 when the explanted generator and lead were returned to the manufacturer for product analysis. Product analysis was completed on the generator on (b)(6) 2011. Bodily fluid remnants were observed in the negative connector block and header cavity. The anomalies in the header area may have been a contributing factor to the adverse events. Corrosion/dried fluids and pitting conditions in the negative connector block and setscrew were observed and are most likely related to the observed fluid ingress of the lead that was returned with this pulse generator. The septum was not cored. In the product analysis 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. Other than the visual observation of the header area, there were no performance or any other type of adverse conditions found with the pulse generator. Although initial visual analysis of the lead showed fluid ingress, full product analysis on the lead is still pending.

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« Reply #9 on: September 27, 2018, 10:02:14 AM »

Model Number 101
Event Date 06/29/2009
Event Type  Malfunction   
Event Description
It was reported that a vns pt had undergone generator revision surgery due to the end of service of the device. The product was returned to the mfr and an analysis of the device confirmed the reported end of service event. During the analysis, it was revealed that the generator exhibited an out-of-limit (higher) leakage current caused by two transistors with in the device. Once the suspect transistors were replaced with known functional bench transistors, the device performed according to specification. Though these transistors could have potentially contributed to the end of service of the device, a battery longevity prediction confirmed that the end of service condition was an expected event. Calculation resulted in -0. 77 years until elective replacement indicator = yes. It was also observed that there was evidence of body fluid intrusion/corrosion in the negative connector block lead hole, which is related to report # 1644487-2009-01885. No surface abnormalities were noted on this device.

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« Reply #10 on: September 27, 2018, 10:04:22 AM »

Model Number 103
Event Date 05/22/2013
Event Type  Malfunction   
Manufacturer Narrative
Further follow-up revealed that the suspect device has changed.
 
Event Description
Further follow-up revealed that the high impedance was likely a result of the generator being programmed on during or prior to surgery. It appears that the high impedance was not observed from diagnostics, but rather after the first interrogation. It is suspected that this is not a true high impedance event and that the generator was displaying a high impedance warning message based on the 24 hour impedance check.
 
Event Description
On (b)(6) 2013 it was reported that the vns patient underwent initial implant surgery and when the generator was connected to the lead, high impedance was observed. The surgeon proceeded to try to re-insert the lead pin; however, he was unable to pull the lead pin out of the generator. It was then pulled so hard that the header of the generator detached. As a result, a new lead and generator were implanted. Diagnostics were fine with the second generator and lead. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator and lead passed all functional tests prior to distribution. The generator and lead were returned to the manufacturer for product analysis on (b)(4) 2013. Product analysis on the generator is still underway and has not yet been completed. It was later reported that during surgery the surgeon tried to remove the lead pin from the header after the first interrogation outside of the generator pocket and that it looked like the header and screwdriver were stripped. So the surgeon proceeded to pull out the pin from the generator and then ended up with the generator in one hand and the torn lead in the other. Product analysis was completed on the lead. The generator was still connected to the lead when received. During the visual analysis the connector boot / inner silicone tubes appeared to be torn in half at the end of the connector ring with the quadfilar coils stretched and kinked in between the two halves. The (+) white and (-) green electrode ribbons appeared to be stretched and the helices misshaped; indicating the lead assembly had been attempted to be used. What appeared to be remnants of dried body fluids were observed on the ribbons. With the exception of the damaged connector boot, the condition of the returned lead assembly is consistent with conditions that typically exist following an attempted implant procedure. Continuity checks of the returned lead assembly were performed with no discontinuities identified. No coil breaks were found. Based on the findings in the product analysis lab, there is no evidence to suggest any device-related anomaly with the returned lead. The tightened setscrew may have contributed to the damaged connector boot.
 
Manufacturer Narrative

Event Description
On (b)(4) 2013 product analysis was completed on the explanted generator. Removal difficulties were related to tightened setscrew on connector pin; the location of setscrew marks on the connector pin suggests there was no adverse effect, from silicon in connector block, on lead insertion process. No detachment of the header was noted during analysis. The removal difficulty was most likely due to the setscrew being tightened on the lead pin. The reported high impedance allegation may be related to the silicone rubber found in the connector block. However, the setscrew marks on the connector pin suggest a complete insertion. The source of the silicone rubber material in the connector block is unknown. Results of diagnostic tests indicated the device operated and communicated properly, the reported high impedance was not duplicated. Electrical test results showed that the pulse generator performed according to functional specifications. Other than the material in the connector block there were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
Review of the device internal data was performed. High impedance message was seen upon interrogation of demipulse generator but resolved after completion of a system diagnostics test. This is an issue related to the generator being programmed on following implant surgery without first performing a system diagnostics test to clear the stored impedance value from the final electrical test. This event is addressed in product labeling to perform system diagnostics prior to programming the device on.

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« Reply #11 on: October 03, 2018, 03:23:26 AM »

Model Number 300-20
Event Date 07/17/2011
Event Type  Malfunction   
Event Description
It was reported that the patient had generator and lead replacement surgery on (b)(6) 2012. The implant card confirmed the date of surgery and indicated the reason for replacement as battery depletion with neos=yes and lead discontinuity. The explanted products were received by the manufacturer on (b)(6) 2012, however product analysis has not been completed to date.
 
Event Description
A physician reported on (b)(6) 2012 that upon interrogation of a patient's model 104 generator, the physician received a warning about low output. The patient's output current was at 1. 0ma, so the company representative instructed the physician to turn the output current up to 1. 5ma. Normal mode diagnostics at 1. 5ma were performed and showed low output current, and then systems diagnostics were performed and showed high lead impedance. On the patient's previous visit on (b)(6) 2012, all diagnostics were reportedly okay. No patient trauma is suspected to have contributed to the high impedance. The patient did pick up a (b)(6) child in (b)(6), and the child wiggled around. The physician was unsure if this may have caused the high impedance. The physician does not suspect that fibrosis would cause the high impedance. The patient has not experienced an increase in seizures. The physician is requesting x-rays be taken of the patient's vns, but it is unclear if the x-rays will actually be taken. Therefore, the x-rays have not been received to date. The physician elected to keep the device programmed on because the patient is doing fine, and he did not want to stop therapy. Although surgery is likely, it has not occurred to date. No additional information was provided.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays received by the manufacturer, no gross lead discontinuities visualized.
 
Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the incorrect date of the event, so the patient age was reported incorrectly. Date of event, corrected data: the initial report inadvertently reported the incorrect date of the event. With the additional information received, the patient's symptoms began around (b)(6) 2011 and the impedance began to increase as first captured on this day.
 
Event Description
It was reported on (b)(6) 2012, that the patient had x-rays taken in (b)(6). The ap and lateral cervical spine x-rays were later received by the manufacturer on (b)(6) 2012. The radiology report was also received which reported that the leads appeared to be radiographically intact. Due to only neck images being taken, the generator cannot be visualized, and thus, resulting commentary on pin insertion and feed-thru wires being intact cannot be assessed. The electrodes appear to be in alignment. There are no gross lead discontinuities or sharp angles present. However, resulting commentary on the area in the chest that is not visible cannot be assessed. In addition, the presence of an unpronounced lead discontinuity or discontinuity in the portion of the lead not seen in the provided x-rays cannot be ruled out. Therefore, there is no indication from the x-rays that would reveal the cause of the high impedance. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
Additional clinic notes were received for the upcoming surgery which has not occurred to date. The notes dated (b)(6) 2011, does not indicate any vns abnormalities or patient adverse events. The vns settings were changed, and there were plans to titrate the settings higher. On the next visit on (b)(6) 2011, it was reported that the patient was "doing somewhat worse since the last visit. " the husband reported that her seizures were slightly worse. He reported a total of eight bigger seizures in the past two months. Her milder, atypical absence episodes are just as long but less intense. There were no recent other changes in the patient's medical history. The patient's vns settings were still titrated up to prior settings, the output currents were increased on (b)(6) 2012. The patient was doing about the same on the (b)(6) 2011, visit. The notes indicated the patient was now reporting about 15-20 seizures in the last 10 weeks on (b)(6) 2012, and the patient was not satisfied with her seizure control. The vns settings were titrated up again. In the notes dated (b)(6) 2012, the patient reported 3 tonic-clonic seizures and four smaller seizures since the last visit. She reported improvement with the vns increase and no side effects, and she was somewhat satisfied with her seizure control at that point. She was doing better since the last visit. An increase in output current was attempted but the patient experienced coughing, so the pulse width was decreased. However, the device indicated high lead impedance from system diagnostics. The physician planned to leave the output current at 1. 0 ma with increased pulse width to 750usec. Attempts for additional information from the physician have been unsuccessful to date. Review of the diagnostic history revealed that a > 25% impedance occurred on (b)(6) 2011.
 
Event Description
The patient reported that she "does not like the magnet because it hurts. " however, the company representative followed up with the physician's office. The clinic notes were provided to him to review, and there was no mention of the patient experiencing pain with the magnet in the notes. In addition, there did not seem to be a recent change in magnet settings. Attempts for additional information from the physician's office were unsuccessful.
 
Event Description
The clinic notes and cover sheet were received from the patient's physician's office. It reported that the patient has been referred for surgical follow up regarding the "lead issues" and the fact that the leads have been implanted for about 12 years. Although surgery is likely, it has not occurred to date.
 
Event Description
Product analysis of the generator and lead was completed. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. During analysis of the explanted lead, an abraded opening in the outer tubing was observed as well as dried body tissue on the positive electrode ribbon. Note that a portion of the lead assembly (body) was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 87 mm portion pitting was observed on the surface of the marked connector pin. The front portion of the connector boot appeared to be detached from the connector pin. Scanning electron microscopy was performed and identified evidence of pitting on the surface of the marked connector pin. A definite cause for the pitting could not be determined based on the lead portion returned. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. Of note, suture indentations were observed on the outer silicone tubing. Manufacturer labeling indicates to not use sutures on the lead body. 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. During the visual analysis, the (+) white electrode ribbon appeared to be embedded in remnants of dried body tissue. This condition may have prevented the electrode ribbon from coming in contact with the vagus nerve; therefore, contributing to the reported allegations. Other than observed pitting on the marked connector pin and tissue-covered (+) white electrode ribbon, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins 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 a discontinuity in the returned portions of the device which may have contributed to the stated allegations.
 
Event Description
Follow up with the physician was performed which revealed that the patient's increased seizures were believed to be due to loss of vns therapy. The patient experienced coughing with attempted increase in vns settings. The increase in the patient's seizures in 2011, were still below pre-vns baseline levels, and there were no clear causal factors for the increased seizures. The patient experienced painful stimulation during vns programming changes on (b)(6) 2012. To prevent morbidity from seizures, the patient's background medication dosing was adjusted while waiting to address the vns issue, per the physician. No additional information was provided.

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« Reply #12 on: October 04, 2018, 03:57:26 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/30/2014
Event Type  Death   
Event Description
A representative of the following neurologist's facility confirmed that the patient was deceased. The representative did not provide a cause of death for the patient. Clinic notes on file for the patient indicated that the patient was admitted to the hospital for abdominal pain and was pronounced dead two days later. It was unknown whether the patient's abdominal pain was related to the patient's death or to the vns. The representative did not provide an assessment regarding the relationship of the patient's death to vns. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Explanted devices were received from another medical device manufacturer. The reason for explant was not indicated; however, an obituary search indicated that the patient implanted with the devices was deceased on (b)(6) 2014. Product analysis was performed on the explanted lead and generator. Analysis was approved for on the returned generator. An end-of-service message was observed on the generator. Review of the data downloaded from the indicated increased impedance; the pre-change impedance value was 1705 ohms, and the post-change value was 19911 ohms. The time of change detection (b)(6) 2014, indicating likely explant on this date. The pulse generator was tested and performed according to functional specifications, and there were no adverse conditions found with the generator. Analysis was approved for the lead. No discontinuities were identified within the returned lead portion. Setscrew marks were observed on the connector pin, providing evidence that proper contact between the setscrew and the connector pin existed at least once. Microscopy showed that pitting occurred on the surface of the connector ring. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant. Note that since a significant portion of the lead, including the electrode array, was not returned for analysis, an assessment cannot be made on that portion of the lead. No anomalies were identified in the returned lead portion. No additional relevant information has been received to date. The circumstances of the device explant have not been confirmed to date.

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« Reply #13 on: October 08, 2018, 01:17:14 PM »

Model Number 302-20
Event Date 03/02/2012
Event Type  Malfunction   
Event Description
A country manager in sweden was notified by a vns surgeon that a patient had their generator explanted for a suspected infection. Their generator was explanted on (b)(6) 2012 and their lead has been left in place as possibly a new generator may be placed later. The patient's surgery was a scheduled planned replacement, no clinical signs of infection, when opening the pouch there was a yellow fluid, possibly from blood and it was noted the generator appeared corroded. Cultures were taken and no infection was confirmed. Since no infection was present, there is likely a correlation between the corrosion and the presence of the stained fluid. There was no patient manipulation or trauma prior to the event. The fluid was noted around the generator, subclavical area. During review of internal programming history it was noted that the patient had high lead impedance on (b)(6) 2008 and later on (b)(6) 2010, a dcdc 0 on their system diagnostic test indicating a possible short circuit condition. At this time the lead remains implanted in the patient.
 
Event Description
On (b)(6) 2013 the programming history for the patient's currently implanted generator was reviewed and high impedance was observed on (b)(6) 2012. The same lead was previously implanted with the patient's previous generator and high impedance was detected. On (b)(6) 2012 patient underwent surgery for generator replacement and the lead was left in place. Good faith attempts for further information were made but no additional information was received.
 
Event Description
Additional information was received through a return product form indicating the reason for explant was due to localized 'empyema' as well as corroded stimulator. At the moment good faith attempts to obtain further information from the treating physician have been unsuccessful to date.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Additional information was received on (b)(6), 2012 when it was discovered that the patient had undergone re-implant surgery on (b)(6), 2012. The vns device had been explanted 6 months prior due to suspected infection.
 
Event Description
Additionally, analysis was completed on the returned generator. Analysis of the returned generator indicated the generator was not corroded. In addition, dried bodily fluid remnants were observed in the header lead cavity, both connector blocks, and the feed-thru area. There were signs of fluid ingress/egress (direction of fluid flow could not be determined) through both of the negative and positive connector blocks backfill areas. Pitting (etching/corrosion) was observed on the negative connector block and setscrew. Nonetheless, the findings of fluid inside the generator possibly contributed to the low dc dc and also high impedance.
 
Event Description
An implant card was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 because the device was dysfunctional. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.

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« Reply #14 on: October 09, 2018, 12:27:11 PM »

Model Number 103
Event Date 05/01/2012
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Additional information was received from the area representative indicating the patient underwent generator replacement surgery. Surgical intervention was initially done to re-insert the lead pin inside the connector block of the generator; however the lead pin could not be pulled out of the generator. Once the lead pin was removed, the surgeon decided to use another generator as he believed the connector block of the old generator was broken. Diagnostics were performed after the use of a new generator and same lead which indicated good impedance values. The explanted generator was returned to the manufacturer and at the moment remains under analysis.
 
Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report.
 
Event Description
It was reported by a company representative that high impedance was received during a follow-up appointment. The patient was implanted 2 weeks prior to the report of high impedance and no patient manipulation or trauma was reported to have contributed to the event. Additionally, the company representative provided a video of implant. Full video of implant procedure was reviewed, which showed 21 seconds of the electrodes attached to nerve, lead pin being inserted into generator, and tightening of the set screw. X-rays were provided to the manufacturer which indicated the generator was able to be visualized and its placement appeared normal. The end of the connector pin could not be visualized past the connector block on the received images. The filter feedthru wires appeared intact, and the lead wires appeared intact at the connector pin. The lead body was also able to be visualized, but there was a portion of the lead behind the generator that could not be assessed. No obvious discontinuities or acute angles were noted. At the moment surgery has been planned for the patient. Programming history was received and reviewed by the manufacturer. Review of history indicated system diagnostics at the time of implant were ok/ok/ 1253 ohms/ ok. The high impedance was confirmed to have occurred on (b)(6) 2012.
 
Event Description
Analysis of the generator the in-line cavity go gage passed the insertion test. A model 304 bench lead was inserted completely passed the negative connector block and was secured with the returned setscrew. The bench lead disconnected from the generator with no difficulties. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

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« Reply #15 on: October 10, 2018, 02:30:54 AM »

Model Number 300-20
Event Date 09/19/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but is not suspected to have contributed to the patient's death.
 
Event Description
A lead for a patient who passed away was received by the manufacturer on (b)(6) 2012, as previously captured in manufacturer report number: 1644487-2011-02547. The product analysis of the lead was completed on (b)(6) 2012. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the cut end and at the suspected pitted area. A significant portion of the lead (including the electrode array) was not returned for evaluation. Since a significant 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. Two sets of setscrew marks were seen on each connector pin providing evidence that proper contact between the setscrew and the connector pin existed at least once. Both the marked and the unmarked connector boot have partial detachment from the pin at the area where the pin exits the boot. Abrasions were identified at the areas located between the end of the connector boots and connector bifurcation. Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead portion.

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« Reply #16 on: October 11, 2018, 06:13:00 AM »

Model Number 302-20
Event Date 05/25/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2012 it was originally reported by a nurse practitioner that the vns patient was scheduled for a full revision surgery as the patient (non-verbal) was experiencing pain near the electrode site. The patient was seen on (b)(6) 2012 and the pain was timed as the patient winces with the pain, and it was found to be associated with stimulation. Normal mode and system diagnostics were run and were within normal limits; system dcdc=2, normal mode dcdc=3. The patient's current settings are: output=1. 5ma/frequency=20hz/pulse width=250usec/on time=14sec/off time=0. 8min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=250usec. Based on just the physical symptoms, the doctor has decided to move forward with a full revision for the patient. No x-rays have been done and will not be done. No setting changes, medication changes, or trauma had occurred prior to the patient's pain. The doctor is aware that the diagnostics show that the device is functioning as intended, but wants to move forward with the full revision in hopes that it will resolve the patient's pain. The reason for the replacement is prophylactic based on the age and the patient's settings. On (b)(6) 2012 the patient had a full revision surgery. Diagnostics were within normal limits prior to surgery and in surgery. Although the revision was because of painful stimulation, the surgery was for patient comfort and not a serious injury. Prior to surgery, the surgeon stated that he thought the helices may have slipped off the vagus nerve but during surgery he noticed that they had not. Everything looked fine when he dissected to the vagus nerve. As vns had been a great success for the patient, the parents and surgeon decided to replace the entire system as vns was the only thing that worked for the patient and they didn't want to lose efficacy. X-rays were taken in the operating room and looked normal. After surgery the patient was going to be programmed to output current of output=1ma/frequency=20hz/pulse width=250usec/on time=14sec/off time=0. 8min/magnet output=1. 25ma/magnet on time=60sec/magnet pulse width=250usec. The explanted lead and generator were returned for product analysis on (b)(6) 2012. The returned product form reported that the patient's system was replaced due to "stimulation causing patient pain and drops". The manufacturer's consultant clarified that these drops were actually a reaction to the painful stimulation. Product analysis of the leads was completed on (b)(6) 2012. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. The positive coil appears to be retracted against the connector ring. The positive coil tubing appears to be torn open at the ring/backfill interface. Further inspection of the lead verified that the inner silicone tubing of the positive coil appears to be torn open at the ring/backfill interface. Based on the appearance of the lead it is believed that this condition was most likely caused by forces exerted on the lead during manipulation of the lead. However, the exact point in time of when this occurred is unknown. The outer silicone tubing is cut at approximately 28. 7cm from boot. The inner silicone tubing of the lead coils is cut/torn in the vicinity of the outer tubing end. A portion of the lead coils is exposed at the end of the returned lead portion. The lead assembly has remnants of what appears to be body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Product analysis of the generator was completed on (b)(6) 2012. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis 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 and there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2630367
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dennis100
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« Reply #17 on: October 11, 2018, 06:13:53 AM »

Event Date 04/12/2012
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury. Type of report, corrected data: inadvertently did not check "30-day" on initial report.
 
Event Description
On (b)(6) 2012, product analysis was completed on the explanted generator. The generator performed according to functional specifications and there were no anomalies found with the pulse generator. Product analysis on the leads was completed on (b)(6) 2012. The electrode array portion of the lead was not returned for analysis, therefore an evaluation and resulting commentary cannot be made on that portion of the lead. The connector boot has what appears to be a bump near the large o-ring resulting in a slight out-of-tolerance dimensional issue; however, setscrew marks show that it did not have an adverse affect on lead pin insertion and did not affect functionality. The lead assembly was cut at approximately 34. 1cm from boot and the outer silicone tubing had a cut opening at approximately 30cm from the boot. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2012, it was reported that the vns patient was scheduled for prophylactic battery replacement that day and during pre-operation diagnostics, high impedance was observed with output=limit/lead impedance=high/eos=no. The patient therefore underwent a full revision surgery to resolve the high impedance. The patient's settings pre-operation was output=0. 75ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=1. 8min/magnet output=0. 75ma/magnet on time=60sec/magnet pulse width=250usec. The surgeon reported that he visualized a lead break in the old lead by the neck inside the silicone. The lead impedance after surgery was reported to be within normal limits. The patient was re-interrogated to ensure it was disabled. The explanted lead and generator were returned for product analysis on (b)(6), 2012 which is still underway and has not yet been completed. The physician later reported that the high impedance was first observed on (b)(6), 2012. No x-rays had been taken. No patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance.

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dennis100
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« Reply #18 on: October 13, 2018, 04:27:17 AM »

Model Number 302-20
Event Date 06/22/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2012, it was reported that a patient underwent total revision on this date and that the explanted devices would be returned to the manufacturer. The generator was replaced due to end of service, and the lead was replaced due to high impedance. A manufacturer's consultant also indicated that these physicians may not be willing to provide additional information. On (b)(6) 2012, the explanted generator and lead were returned and are currently undergoing product analysis. A returned product form received on (b)(4) 2012, indicated that the lead came out in pieces and the largest piece was returned. A battery life calculation was performed on (b)(4) 2012. The results indicated negative years to eri = yes. On (b)(6) 2012, it was reported that the physician would not provide any additional information regarding these events.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis for the explanted generator and lead was approved on (b)(6) 2012. The near end of service flag was set (n eos = yes) for the generator. The battery was partially depleted and determined to be the result of normal expected battery consumption based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Only a section of the lead was returned for product analysis. The lead's electrodes were not returned. Two tie-downs were returned with the lead. Two sets of setscrew marks were seen on the connector pin, providing evidence that contact between the setscrew and the lead pin existed at least once. One of the setscrew marks is located toward the end tip of the connector pin. Also, the connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The exact point in time when this occurred is unknown. Based on the location of the 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. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. Abrasions were identified on the connector boot. Abrasions were identified on the outer silicone tubing at multiple locations. White deposits were identified on the outer silicone tubing at various locations. The lead assembly has remnants of what appears to be dry body fluid inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion. An energy dispersive spectrometry analysis performed on a sample of the white deposits identified si, p, ca, na, and mg as the composition for the substance. The exact reason for the presence of the substance is unknown. The lead assembly was returned for analysis due to high impedance. The reported high impedance allegation was not verified within the returned lead portion. 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. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

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dennis100
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« Reply #19 on: October 18, 2018, 01:16:12 AM »

Model Number 302-20
Event Date 01/10/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a serious injury or death.
 
Event Description
On (b)(6) 2013, it was reported that the patient had both her generator and lead replaced on (b)(6) 2013 due to end of service and high impedance respectively. Per the implant card, the replacement surgery was due to a lead discontinuity with lead impedance marked as high. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided. The explanted devices have not been returned for product analysis.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.
 
Event Description
Product analysis of the explanted generator found that the battery was not at an ifi condition. The battery voltage measured 2. 881 volts as measured during completion of test parameter 7. 16. 10. 2 of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 11. 989% of the battery had been consumed. With the exception of parameters related to the reed switch, results of the final electrical test were successful. Functional bench testing, and internal downloaded data from the generator, both demonstrate that consistent magnet activations are attainable. With the exception of the noted test-related issue, there were no adverse functional, mechanical, or visual issues identified with the returned generator. Review of the device history records for the lead confirmed the lead met all final testing specifications prior to distribution. Attempts were made for additional information; however, they were unsuccessful. No additional information has been provided.
 
Event Description
Product analysis of the lead was completed and approved on (b)(6) 2013. Two sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. A reddish-brown substance was noted on the connector pin in the vicinity of the end tip. The connector pin has what appears to be pitting at this location. Also, the connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The exact point in time of when this occurred is unknown. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. Abrasions were identified on the connector boot and on the outer silicone tubing at multiple locations. The lead coils have a spiral appearance along the lead body. The lead coils are stretched along the lead body. The inner silicone tubing appears to have been cut/torn at approximately 38. 5cm from boot. The inner silicone tubing of the lead coils has what appear cut openings in the vicinity of the tubing ends. The cut ends of the lead coils are located at approximately 38cm from boot. The outer silicone tubing has internal abrasions at approximately 33. 5-36. 9cm from boot. The end of the outer silicone tubing appears to have been cut/torn at approximately 38. 3cm from boot. The lead assembly has remnants of what appears to be dry body fluids inside the inner silicone tubing of the lead coils. No obvious point of entrance was identified other that cut end of the returned lead portion. Incisions in the silicone tubing were necessary to perform proper inspection of the lead coils. Scanning electron microscopy images of the connector pin showed that pitting or electro-etching conditions have occurred on the pin. The exact reason for this condition is unknown. 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. Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2968711
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dennis100
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« Reply #20 on: October 19, 2018, 11:14:18 AM »

Model Number 302-20
Event Date 08/14/2012
Event Type  Malfunction   
Event Description
Additional information was received indicating that x-rays were taken; however, the device was not visible. Attempts to obtain new images were unsuccessful. The patient's increase in seizures was attributed to the high impedance. The patient underwent revision on (b)(6) 2012. The new device was successfully implant and verified to be working properly. The generator was replaced prophylactically. After re-implant, the patient responded to treatment. The lead and generator were received on (b)(6) 2012. Product analysis for the explanted lead showed that the reported "high impedance" allegation was not verified within the returned lead portion. 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. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Four sets of 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 connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The exact point in time of when this occurred is unknown. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. White deposits were identified on the connector boot in the vicinity of the ring/backfill interface. Abrasions were identified on the connector boot. The outer silicone tubing has what appear to be abrasions/imprints. The outer silicone tubing appears to have been compressed at three locations. Abrasions most likely caused by the presence of a tie-down were identified; the outer silicone tubing is cut open at approximately 33 cm from boot. No obvious damage to the lead coils or the inner tubing was noted at this location. The outer silicone tubing has what appear to be internal abrasions at multiple locations. Abrasions were identified on the silicone tubing of the lead coils. The lead assembly has remnants of what appears to be body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. No discontinuities were identified within the returned lead portion.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned but did not cause or contribute to a death.
 
Event Description
On (b)(6) 2012, it was reported that normal mode and system diagnostics for a vns patient indicated high impedance. Diagnostics were repeated with the same results. The device subsequently programmed off. The physician requested a new generator due to the fact that this generator was implanted in 2008. The event was reported to be continuous, of moderate severity, and possibly related to stimulation. Device parameters were changed as intervention. It was also noted that the patient had an increase in seizures over the previous seizure rate. The patient reportedly has generalized tonic-clonic seizures and atonic seizures. The patient's settings and diagnostics from this date were provided. Additional information was received that x-rays were taken and would be provided for manufacturer review; however, they have not been received to date. The patient had not had any fall, injury or manipulation of her vns lead that could be attributed to the high impedance. The increase in seizures was over thee pre-vns seizure rate at baseline rate two months prior. The physician attributed the loss of therapy to the high impedance. Adjustments to mediation were made to treat seizures and to preclude a serious injury. Surgery is likely, but has not occurred.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Product analysis for the explanted generator was completed on (b)(6) 2012. The pulse generator was explanted/returned due to prophylactic replacement. 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. A battery life calculation on (b)(6) 2012 indicated 6. 49 years remaining.
 
Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2744314
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