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dennis100
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« Reply #120 on: May 11, 2019, 12:45:04 AM »

Model Number 106
Device Problem Detachment of Device or device Component
Event Date 03/20/2019
Event Type  Malfunction   
Event Description
Initial report was that the generator's septum plug came out of the generator during lead pin insertion during surgery. The surgeon attempted to replace the septum plug and it was noted that the septum plug would not seat properly in the generator. The lead insertion was noted to be without difficulties. A backup generator was used in place. The device history records for the generator were reviewed and show that no unresolved non-conformance's were found. The device met all specifications for release prior to distribution. The product was received by product analysis. Product analysis has not been completed to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8506083
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dennis100
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« Reply #121 on: May 14, 2019, 12:51:36 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/06/2011
Event Type  Injury   
Event Description
It was reported by the patient¿s mother that her son has more seizures when his battery reaches 25%, and that the neurologist increases the keppra dose to counteract the seizures. The patient had generator replacements in 2007, 2011, 2015, and is scheduled for replacement currently. The increase in seizures in 2007 is reported under mfr. Report # 1644487-2007-01077, the increase in seizures in 2015 is reported under mfr. Report # 1644487-2019-00636, and the increase in seizures in 2019 is reported under mfr. Report # 1644487-2019-00652. This report concerns the increase in seizures in 2011 and subsequent generator replacement. The generator replacement was initially reported to be prophylactic. The explanted generator was later received by the manufacturer and an analysis was performed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Additionally, the generator¿s header was found to be detached, but based on the observed tool marks on the pulse generator case it is very likely that this occurred during or after the explant procedure. Other than the header anomaly, there were no performance or any other type of adverse conditions found with the pulse generator. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8491278
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dennis100
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« Reply #122 on: May 14, 2019, 12:52:27 AM »

Model Number 302-20
Device Problems Detachment Of Device Component; Fluid Leak; High impedance
Event Date 01/12/2015
Event Type  Malfunction   
Event Description
It was reported by the physician's office that the patient was referred for a vns consult for an unknown reason and the plan was for vns generator replacement, but a lead replacement may also be needed. No information was initially provided. An implant card was later received showing the patient underwent a full vns revision. The diagnostics for the old device showed high impedance. It was also explained that the lead had visible "holes" and fluid within the silicone tubing. Diagnostics with a new generator and the old lead still showed high impedance. Adequate insertion of the lead pin into the generator was confirmed, but the high impedance did not resolve. The new generator was tested using the resistor pin and confirmed good diagnostics. Upon exposing the electrodes within the neck, it could be seen that one of the electrodes was no longer wrapped around the vagus nerve. Per the anesthesiologist, the patient had been known to have severe falls due to seizure activity and the compromises in the lead may have occurred during one of the falling evens. Once both the lead and the generator were replaced, diagnostics were within normal limits. The explanted generator and lead were reported to be discarded after the surgery.
 
Manufacturer Narrative
This information was inadvertently reported incorrectly on the initial mfr. Report.
 
Event Description
The programming history database was reviewed and no anomalies related to the high impedance was noted. Additional information was received from the patient's following physician stating the reason for the vns replacement referral was due to battery depletion and high impedance. Additionally, the physician did not know the cause of the holes, fluid leaks, or electrode detachment from the nerve.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6461922
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dennis100
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« Reply #123 on: May 18, 2019, 12:38:59 AM »

Model Number 106
Device Problem Detachment Of Device Component
Event Date 05/05/2017
Event Type  Malfunction   
Event Description
It was reported that a generator's septum plug became detached during implant surgery. The septum plug was reportedly stuck to the hex screwdriver. The septum plug was then reattached to the generator header. System diagnostics were performed and returned normal values. No other abnormal instances occurred during the surgery. The physician opted to leave the generator implanted in the patient. A review of the manufacturing record for the generator confirmed it had passed all quality inspections prior to release for distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6598123
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dennis100
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« Reply #124 on: May 18, 2019, 12:39:44 AM »

Model Number 106
Device Problem Detachment Of Device Component
Event Date 02/11/2017
Event Type  Malfunction   
Event Description
It was reported the patient underwent repositioning surgery for patient comfort. During the surgery, the surgeon had unscrewed the setscrew so that the vns generator could be removed from the lead for repositioning. It was noted the septum was no longer lying flat and it was explained that it could be pushed back down flush as it likely dislodged while unscrewing the setscrew. It was later explained the vns generator had to be replaced as the septum popped out when the surgeon attempted to push it back down flush. The device history record was reviewed and confirmed the vns generator passed all tests prior to distribution. The vns generator was received by the manufacturer. While analysis is expected, it has not been completed to date.
 
Event Description
Analysis was completed on the received generator however it was noted that the septum was not received. During analysis the generator performed to functional specification. During dimensional assessment, the header septum cavity was measured and found to be outside of specification (higher than the maximum upper limit). The header lead cavity was measured and found to meet specification. Receiving inspection documentation was reviewed for the lot of septum cavities used to manufacture the generator. No anomalies were observed with the sampled septum cavities. A company representative reported that the following explant the generator left the or and underwent a process prior to being returned to the manufacturer. It was unclear what type of sterilization process the generator may have been exposed to that could have potentially affected the dimensions of the septum cavity. Further follow-up with the explanting facility found that there was no record of the generator undergoing additional sterilization after explant and prior to return to the manufacturer. The cause of the out of specification septum cavity could not be determined as it was unclear if the generator was exposed to additional sterilization after explant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6600771
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dennis100
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« Reply #125 on: May 18, 2019, 12:40:39 AM »

Model Number 302-30
Device Problems Fracture; High impedance
Event Date 02/09/2017
Event Type  Malfunction   
Event Description
It was reported that high impedance was found on the patient's device when interrogated. The patient had an x-ray performed where it was stated no break could be seen. The x-rays have not been reviewed by the manufacturer to date. The patient was referred for a lead replacement due to the high impedance. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient underwent surgery where the vns generator was replaced and the high impedance resolved. No fractures were observed at the time of the surgery so the lead was not initially replaced. The explanted generator was tested on its own and found to be functioning properly. After the surgery the device was programmed on and intermittent high impedance was observed. This indicated that there might be an intermittent microfracture. The patient was returned to the operating room and the lead was replaced. Impedance was then within normal limits with the new lead and generator. The explanted lead and generator was discarded following the surgery.
 
Event Description
The manufacturer received two user facility medwatch reports related to the events previously captured in this report, (b)(4).
 
Event Description
It was reported that the explanted products were actually not discarded and were available for return. The products have not been received to date.
 
Manufacturer Narrative
Corrected data: describe event or problem; "the explanted lead and generator were received" this information was inadvertently left off on mfg. Report #3. Corrected data: device available for evaluation?; this information was inadvertently left off on mfg. Report #3.
 
Event Description
The explanted lead and generator were received and underwent product analysis. The generator performed to functional specification during analysis. No anomalies were observed during a series of diagnostic tests and interrogations. It was noted only a portion of the lead was received and the segment did not contain the electrodes. Upon visual analysis it was found that the lead¿s pin had two full sets of set screw marks, indicating proper contact between the generator and lead had existed at one point in time. However there was a single set screw mark near the end of the lead pin which indicated that proper contact was not occurring at one point in time. It was unclear when this partial connection occurred. The lead's connector boot was partially detached and there were abrasions near the connector boot. The reason for the partial detachment and abrasions was unknown. Abrasions were noted in the outer tubing in multiple locations and there was fluid inside the inner and outer tubing. The only obvious point of entry was the end of the lead that had been cut during the explant and the abrasions in the outer tubing. Continuity testing was performed on the lead and no discontinuities were identified within the returned lead portion. Other than the abraded outer insulation, no other anomalies were identified in the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6603299
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dennis100
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« Reply #126 on: May 18, 2019, 12:41:27 AM »

Model Number 303-20
Device Problems High impedance; Difficult to Insert
Event Date 05/09/2017
Event Type  Malfunction   
Event Description
It was reported that a lead could not be fully inserted into a generator, causing high impedance to occur during implant surgery. The surgeon tried removing and reinserting the lead multiple times, but the high impedance continued to occur. The lead could not be implanted due to the high impedance/insertion difficulties. The generator was tested with a test resistor and confirmed that it was accurately measuring impedance values. A different lead was implanted and post-op impedance values were all within normal limits. The lead that was not implanted has not been received by the manufacturer to date.
 
Event Description
The lead that was unable to be inserted was returned to the manufacturer for analysis. The visual analysis of the lead found the small o-ring appeared partially detached from the connector pin. Dimensional analysis was performed on the small o-ring, the large o-ring, the connector pin, and the connector boot and provided results all within normal limits. A half set of screw marks was identified on the lead pin confirming that the lead had not been fully inserted during implant. Continuity checks of the returned lead assembly verified that there were no discontinuities present. The remainder of the lead was within specifications and no other abnormal performance or other adverse conditions were identified.
 
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 0. 135 in 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. This lead had both characteristics. The lead's large o-ring boot diameter was 0. 134 in, which is close to the 0. 135 inches specification max and therefore, may cause pin insertion difficulties. In addition, 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6604102
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dennis100
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« Reply #127 on: May 18, 2019, 12:42:11 AM »

Model Number 106
Device Problem Detachment Of Device Component
Event Date 03/08/2017
Event Type  Malfunction   
Event Description
It was reported that the septum plug fell out when the surgeon when he took it out to insert the lead. The generator was not used and the patient was implanted with a different generator. The suspect device was received and was returned due to "faulty generator/loose screw. " analysis is underway but has not been completed to date. A review of device history records for the generator shows that no unresolved non-conformances were found.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis was performed on the returned generator and showed that the pulse generator performed according to functional specifications. Detachment of the septum plug was observed ¿as received¿ prior to decontamination, which may possibly be implant-related damage. The returned setscrew shows mechanical wear on the socket (suggesting numerous insertion attempts) and septum debris is in the socket (verifies the setscrew was extracted up into the septum). In addition, the returned septum shows damage on the underneath side, which indicates the setscrew was extracted up into the septum, which may have been the contributing factor for the detachment of the septum plug. The header septum cavity and returned septum meets specification requirements. Other than the noted septum plug detachment, 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=6453706
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dennis100
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« Reply #128 on: May 18, 2019, 12:42:52 AM »

Model Number 304-20
Device Problems Detachment Of Device Component; Fracture
Event Date 04/27/2017
Event Type  Malfunction   
Event Description
It was reported that a neurologist observed high impedance on a patient's device during a clinic visit. The neurologist reported that high impedance was not observed during the previous clinic visit (b)(6) prior. The patient's family also reported that she had fallen during her seizures. The patient was referred for surgery. No additional relevant information has been provided to date. No surgical intervention has occurred to date.
 
Event Description
The patient's father reported that the patient was experiencing an increase in seizures due to the high impedance. According to the patient's father, the surgeon believed that the lead may have become dislodged from the patient's vagus nerve. The patient underwent full revision surgery. The surgeon and company representative confirmed that the electrode had become dislodged from the nerve, but the surgeon did not know what caused the electrode to come off of the nerve. The explanted lead and generator were discarded and are unavailable for analysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6586456
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dennis100
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« Reply #129 on: May 20, 2019, 09:14:57 PM »

Model Number 102
Device Problem Detachment Of Device Component
Event Date 04/19/2017
Event Type  Malfunction   
Event Description
It was reported that during a prophylactic generator replacement surgery, the explanted generator was found to have a detached header. The surgeon stated the generator had been implanted under the muscle so he believes that put more pressure on the generator and caused the header to break off. Review of the manufacturing records for the generator revealed no anomalies during the manufacture of the device. The explanted generator was received 05/05/2017. Analysis is underway, but has not been completed to-date. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Event description, corrected data: it was inadvertently not provided on the initial report that the pre-operative diagnostics were within normal limits. (b)(4).
 
Event Description
Pre-operative diagnostics were within normal limits. Analysis was completed for the returned generator. The reported detachment of the header was confirmed. The detachment of the generator header was most likely the result of inadequate adhesive application during manufacture. A lack of adhesive was found on the can and header.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6566110
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dennis100
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« Reply #130 on: May 27, 2019, 10:59:24 PM »

Model Number 105
Device Problem Detachment Of Device Component
Event Date 05/31/2017
Event Type  Malfunction   
Event Description
It was reported that during the patient¿s surgical case, the septum plug and setscrew popped out of the new intended replacement generator. Prior to this occurrence, diagnostic results of the generator connected to the lead outside the implant pocket were within normal limits. It was at the point, the screwdriver was removed from the setscrew that the septum plug came out. The surgeon tried to put the septum plug back in, but it would not stay in. The setscrew also came out with reportedly little or no manipulation. The generator was not used in the patient¿s implant case. The generator device history record was reviewed by the manufacturer. It was found that all quality tests passed prior to distribution. The unused generator has not been received by the manufacturer to date. No additional pertinent information has been received to date.
 
Manufacturer Narrative
Corrected data: the initial report inadvertently listed the wrong contact as the initial reporter.
 
Event Description
The generator was received by the manufacturer for product analysis. Product analysis was completed on the returned generator. Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted on this device. Both interrogation and system diagnostic tests were performed. An electrical load was attached to the pulse generator, and results of diagnostic test demonstrate that accurate resistance measurements were obtained. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 2. 995 volts during functional testing and showed an ifi=no condition. The internal device data showed that 1. 519% of the battery had been consumed. The microscopic visual assessment of the septum shows no visual anomalies. The visual assessment of the returned set screw shows mechanical wear to the set screw socket, suggesting numerous insertion attempts. The socket was not stripped. The set screw also shows indention marks on the bottom of the set screw, which indicates that a lead pin or test resistor was secured with the returned set screw. Manipulation of the torque wrench may have been the contributing factor for the component detachment. The septum and septum cavity met all dimensional requirements. Besides the observed detached components, there was no evidence of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6652810
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dennis100
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« Reply #131 on: May 27, 2019, 11:00:21 PM »

Model Number 304-20
Device Problems Corroded ; Fluid Leak; Fracture; Appropriate Term/Code Not Available
Event Date 04/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for a vns lead and generator replacement due to high impedance being observed. It was also noted that the patient was experiencing an increase in seizures. The physician reviewed x-rays of the patient and did not observe any obvious fractures however the patient¿s mother reported that the patient ¿messes with it all the time¿. X-rays were reviewed by the manufacturer and no obvious fractures were observed. Based on the ap view there appeared to potentially be a sharp angle in the region of the lead near the strain relief, however due to the quality of the image this could not be confirmed in the lateral view. Also due to the quality of the image provided the integrity of the lead near the lead pin could not be assessed. The connector pin did appear to be fully inserted into the generator and the generator¿s feed thru wires appeared intact. Based on the images provided no obvious source of the high impedance could be identified. It should be noted that the presence of a microfracture cannot be ruled out. It was later reported that the patient's family decided to disable the device before going forward with surgery. No surgical interventions are known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was further clarified that the increase in seizures began approximately a month prior to the high impedance warning being observed. At a later follow-up visit it was reported the patient continued to be experiencing an elevated seizure frequency and the patient's parents decided to change the patient's prescription medications rather than replacing the vns device.
 
Event Description
Patient plans to undergo full revision surgery. No known surgical interventions have occurred to date.
 
Event Description
Patient underwent full revision surgery. The surgeon took out the old generator but in the process he bent the header too much to where it broke the seal on one side. The new generator was connected to the lead and system diagnostics was performed again resulting in high impedance and >10,000 ohms. The lead was thus taken out. The surgeon noted that the lead wire was completely separated from the silicone cover in the middle portion. The surgeon was able to remove one of the electrodes but the other two helices were left on the nerve. The new lead electrodes were placed above the old electrodes. The explanted devices have not been received to date.
 
Event Description
The explanted generator and lead were received. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the pa lab. 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 battery, 3. 011 volts , shows an ifi=no condition. The data in the generator memory locations revealed that 13. 112% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway and has not been completed to date. In addition, the header was partially detached from the pulse generator case, which is not typical in a surgical procedure. It is very likely that the header was separated from the pulse generator case during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case and header. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during the explant process. This will not be coded as it is due to explant process.
 
Event Description
Break was identified in the positive coil at two locations. Also, abraded openings were identified in the positive and the negative lead coils. Scanning electron microscopy of the positive coil show that pitting or electro etching conditions occurred at the 1st break location. Also, scanning electron microscopy images of the positive coil breaks (break-1 mate end, and break-2 ends) showed what appears to be wear (flat surfaces) on the coil strands, resulting in a reduction of the diameter of the quadfilar coil strands up to the break point. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6646622
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dennis100
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« Reply #132 on: May 27, 2019, 11:01:01 PM »

Model Number 304-20
Device Problem Low impedance
Event Date 05/30/2017
Event Type  Malfunction   
Event Description
A neurologist observed a low impedance error message when she interrogated the patient's device. The patient underwent full revision surgery. The surgeon believed that the original lead may have slipped off the patient's nerve, resulting in the low impedance. The explanted lead and generator were not returned for analysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6663167
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« Reply #133 on: June 01, 2019, 03:26:34 AM »

Model Number 102R
Device Problem Detachment Of Device Component
Event Date 05/12/2017
Event Type  Malfunction   
Event Description
During a generator replacement surgery due to battery depletion, it was reported that when the surgeon removed the generator from the patient, its septum plug fell out. The physician did not manipulate the device in any way. System diagnostics prior to surgery were within normal limits. The device history records were reviewed and it was confirmed that the generator passed all functional tests and quality inspection prior to final release. No further relevant information has been received to date. The product was received but product analysis has not been completed to date.
 
Event Description
Product analysis was completed on the suspect generator and it was found that the septum plugs of the generator were in place. Instead, the header was found to be detached. Product analysis found that the header detachment most likely occurred during the explant procedure and it was possible that the feedthru wires in the header were broken during the explant procedure. After test wires were used to attach the generator to the final test fixture, the device performed according to functional specifications. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6616010
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« Reply #134 on: June 02, 2019, 01:02:53 AM »

Model Number 106
Device Problem Detachment Of Device Component
Event Date 06/13/2017
Event Type  Malfunction   
Event Description
During a new patient implant, the surgeon backed the setscrew all the way out and it could not be put back in. The surgeon used a new generator for the surgery. The suspect generator was received and analysis is underway.
 
Event Description
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 ¿detachment of component(s) septum plug¿, was observed ¿as received¿ prior to decontamination, the septum was inserted up-side down in the header septum cavity, which may possibly be implant-related. In addition, the returned set screw shows mechanical wear on the socket, suggesting numerous insertion attempts. Furthermore, the returned septum shows what appear to be tears in the body of the septum, suggesting that the torque wrench was pushed into the septum, which may have been the contributing factor for the detachment of septum plug. 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=6695459
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« Reply #135 on: June 02, 2019, 01:03:52 AM »

Model Number 304-20
Device Problems Fracture; High impedance
Event Date 05/13/2017
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2017 that the patient had high impedance. Her device was disabled. Clinic notes reported that the patient felt that the magnet wasn't working as the magnet swipes didn't make her cough like typically had before. No known surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
The patient underwent full revision surgery due to the high impedance. During explant of the lead, the surgeon noted that the patient's lead was not attached to the vagus nerve. All parts of the lead were anterior to the carotid artery. The surgeon said that the electrodes were around 0. 5 inches away from the vagus nerve. The suspect device has not been received to date. No further relevant information has been received to date.
 
Event Description
The patient's lead and generator were received into product analysis. Pa was completed on the returned lead. The lead was returned in 3 portions without tie-downs. Set screw marks were observed on the lead pin, indicating that at one point in time, there was a good electromechanical connection between the lead and generator. The condition of the returned lead portions was consistent with those that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portions were performed during the visual analysis, and no discontinuities were identified. Product analysis was completed on the returned generator. The generator was monitored in a simulated body-temperature environment for over 24 hours. The generator provided the expected output current for the entirety of the monitoring period. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrated that accurate resistance measurements were obtained in all instances. The generator performed according to functional specifications with no anomalies found. The surgeon and the treating physician indicated that they didn't know what caused the patient's electrode to migrate off the nerve. The treating physician did not know of any trauma to the neck site. No further relevant information has been received to date.
 
Manufacturer Narrative
Supplemental mdr 1-- describe event or problem, corrected data:supplemental mdr 1 inadvertently reported that the suspect product hadn't been received instead of "the suspect lead and the generator were received and pending completion of product analysis. " supplemental mdr 1-- device available for evaluation?, corrected data: supplemental mdr 1 inadvertently reported that the patient's product had not been received. However, prior to submission the mdr the product was received on 08/31/2017. Supplemental mdr 2-- date received by manufacturer (mo/day/yr), corrected data: supplemental mdr 2 inadvertently reported 08/31/2017 as the aware date instead of 09/13/2017.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6694894
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« Reply #136 on: June 05, 2019, 12:45:01 AM »

Model Number 103
Device Problems Detachment Of Device Component; Fracture; High impedance
Event Date 06/14/2017
Event Type  Malfunction   
Event Description
An implant card was received which reported that the patient underwent a lead and generator replacement due to high impedance and battery depletion. No additional relevant information has been received to date.
 
Manufacturer Narrative
Corrected data: expiration date; this information was inadvertently reported incorrectly on mfg. Report #0.
 
Event Description
It was reported that high impedance was observed during the last visit however at the previous visit the impedance was noted to be higher, although still within acceptable limits. At the surgery the lead's pin was re-inserted into the existing generator however the high impedance did not resolve. The generator and lead were then replaced. Acceptable impedance was observed with the new generator and new lead. The explanted products have not been received to date.
 
Event Description
It was reported that x-rays were taken prior to the surgery and the physician could not identify anything wrong with the lead. During the surgery the surgeon intended to complete pin insertion troubleshooting however he found that the set screw would not tighten and the high impedance remained. When the generator was explanted the septum plug (covering the set screw) and set screw feel out of the generator without any interference. A new generator was then connected to the existing lead and the impedance was found to be ok. The explanted generator was then put in a sterilization solution before being packaged to be returned for analysis however during the cleaning process the set screw and septum plug were misplaced. The manufacturing records for the generator were reviewed and confirmed that the generator passed quality control inspection prior to distribution. The generator was received and is currently pending analysis.
 
Event Description
Analysis was completed on the returned generator. Visual assessment found that the generator had scratches on the can and header consistent with manipulation that occurs during the explant procedure. It was noted that the septum and set screw were not received with the generator. Dimensional analysis confirmed that the header septum cavity meet specification requirements. A test resistor was secured in the header on the bench using a pa set screw. Then a series of interrogations and diagnostic tests found that the generator performed normally and the battery indicator was ifi = no. During electrical testing the generator performed to functional specification. Since the detached septum and set screw were not returned these components could not be analyzed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6772300
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« Reply #137 on: June 06, 2019, 02:01:33 AM »

Model Number 105
Device Problems Detachment Of Device Component; Fluid Leak
Event Date 09/15/2017
Event Type  Malfunction   
Event Description
Report received that fluid was found in the generator header. A patient had been receiving a lead revision due to low impedance. Low impedance was reported in mfr. Report #1644487-2017-04471. While replacing the lead, the septum plug on the generator was unintentionally removed. This required the generator to be explanted. Upon explant, fluid was found in the generator header. The generator was replaced. A device history performed on the generator showed all quality inspections were performed and passed prior to release for distribution. The generator has not been received by the manufacturer to date. No further relevant information has been received to date.
 
Event Description
Further information was received that the fluid found in the generator header was due to the detachment of the silicone tubing reported in mfr. Report #1644487-2017-04471. There was no generator malfunction that caused the fluid to enter the generator header. The generator was received by the manufacturer but product analysis has not been completed to date. No further relevant information has been obtained.
 
Event Description
Product analysis was completed on the generator. Visual examination was performed, and besides typical marks and discoloration associated with explant, no anomalies were found. The septum plug was not returned. No bodily fluid remnants were observed in the header septum cavity. Both an interrogation and system diagnostic test were performed. Lead impedance and current delivered were normal for all tests performed. The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current. 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. The septum cavity size was within specification requirements. There were no performance or any other type of adverse conditions found with the pulse generator. The downloaded data from the generator was also reviewed. An auto-measurement was performed and provided the battery voltage and estimated charge consumed. The values were normal. No further relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6874741
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« Reply #138 on: June 08, 2019, 05:05:35 AM »

Model Number 106
Device Problem Detachment of Device or device Component
Event Date 05/01/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was receiving a replacement due to battery depletion. During the replacement surgery, the initial generator used had the septum plug come out after using the torque wrench therefore it was not used. A backup generator was used for the replacement. The generator has not been received for analysis to date. No additional relevant information had been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8631636
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« Reply #139 on: June 09, 2019, 12:48:08 AM »

Model Number 106
Device Problem Detachment Of Device Component
Event Date 08/29/2017
Event Type  Malfunction   
Event Description
During a lead revision surgery, the setscrew came out of the generator, and therefore the generator was replaced as well. A review of device history records for the generator shows that no unresolved non-conformances were found. Additional information was received reporting that the doctor barely unscrewed the set screw and the screw backed out. No other relevant information has been received to date.
 
Event Description
The product has been received by the manufacturer and analysis is underway but has not been completed to date. No additional relevant information has been provided to date.
 
Event Description
The generator underwent product analysis. The device was monitored and showed no signs of variation in the output signal. The pulse generator diagnostics were as expected for the programmed parameters. The detachment of the set screw, was observed when the product was received. The returned set screw shows mechanical wear on the socket, suggesting numerous insertion attempts. In addition, the underneath side of the returned set screw shows indention marks, suggesting a lead pin or an in-line test resistor was once secured by the set screw. The returned septum shows damage on the underneath side, which suggest the returned set screw was extracted up into the returned septum, which may have been the contributing factor for the detachment of components. There were no performance or any other type of adverse conditions found with the pulse generator.

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« Reply #140 on: June 10, 2019, 12:32:21 AM »

Model Number 302-20
Device Problems Corroded ; Fracture; High impedance
Event Date 08/02/2017
Event Type  Malfunction   
Event Description
It was reported that the patient's device was showing high impedance before a prophylactic generator replacement. During the surgery, the lead was pulled from the old generator and reinserted to rule out a pin insertion issue. High impedance was still observed after reinserting the pin. The generator was explanted and generator diagnostics were performed to rule out a generator malfunction. The generator diagnostics were ok, so the surgeon went forward with the lead replacement. When the surgeon went to remove the lead, it was noted that there was a lot of scar tissue. The lead also appeared to be hanging off the nerve by only the top electrode. The lead and generator were replaced. Further information was received from the physician that high impedance had been observed at a clinic visit prior to the referral for generator replacement and the high impedance was thought to have been caused by a lower battery. The products have not been received by the manufacturer to date. No additional relevant information has been received to date.
 
Event Description
The explanted lead and generator were received by the manufacturer. Product analysis has not been completed to date.
 
Event Description
Generator analysis was completed. There were no other issues noted and the generator passed the final test for the m102 devices. No abnormal performance or any other type of adverse condition was found with the generator. Lead analysis was also completed. There was a significant portion of the lead not returned including the section which contained the manufacturing id making it impossible to verify the serial number. There was only one returned portion of the lead returned which did not contain the pin or the electrodes. The segment returned contained the anchor tether and was cut right above that. A coil break was noted and believed to be the negative coil. Sem was performed on the lead break observed which showed that pitting or electro-etching conditions occurred. The broken coil appears to be caused by a fatigue fracture. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

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« Reply #141 on: June 10, 2019, 12:33:13 AM »

Model Number 303-20
Device Problem High impedance
Event Date 10/04/2017
Event Type  Malfunction   
Event Description
Report received that a patient's vns was interrogated and a system diagnostic was run which showed high impedance. The patient reportedly did not have any adverse events associated with the high impedance. The patient reportedly had a generator replacement about 11 months prior to the high impedance being present. X-rays were taken and returned to the manufacturer for analysis. The complete insertion of the connector pin into the connector block could not be accurately assessed because of the quality and angle of the image. The feedthru wires appeared fully intact. There appeared to be a strain relief bend present secured by two tie-downs. However, there was no strain relief loop present. A lead fracture was not identified in the image. The lead wire did appear to be fully connected at the connector pin. The electrodes appeared to be placed adjacent to one another instead of vertically. A review of the programing history did not indicate whether high impedance was present prior to this finding. There was reportedly no trauma that would have caused the high impedance. Surgical intervention has not occurred to date.
 
Event Description
Further information was received that the patient's lead was replaced. While in the or, it was found that the lead electrodes appeared to be off the nerve as the anchor tether was outside the carotid sheath. The lead was discarded after surgery. A review of the patient's last implant card showed that impedance was normal after the last generator replacement. No further relevant information has been received to date.

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« Reply #142 on: June 11, 2019, 12:36:27 AM »

Model Number 103
Device Problem Detachment Of Device Component
Event Date 10/03/2017
Event Type  Malfunction   
Event Description
Report received that during an implant procedure, the septum plug was incidentally removed. Further information was received that the septum plug was already removed when the surgeon went to place the generator in the patient's pocket. The surgeon indicated that nothing unique occurred during tightening or retracting the setscrew. It was later reported that the generator with the detached plug was implanted. A system diagnostic test was taken in the or and showed normal impedance, so the surgeon decided to implant the generator. The removed plug was received by the manufacturer but analysis has not been completed to date. A review of the generator device history record indicated it had passed all quality inspections prior to release for distribution. No further relevant information has been obtained.
 
Event Description
Product analysis was completed on the returned generator septum plug. The septum was not cored, however slight damage to the septum was observed. This damage was consistent with damage found after surgical tool manipulation. The septum's overall diameter, cap diameter, and width measurements were taken. With the exception to the damage seen, the septum met all specification requirements. No anomalies were found. The generator was not returned and therefore it was not analyzed. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6988583
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« Reply #143 on: June 12, 2019, 02:32:43 AM »

Model Number 106
Device Problems Detachment Of Device Component; Premature End-of-Life Indicator
Event Date 09/13/2017
Event Type  Malfunction   
Event Description
It was reported that the patient¿s device was explanted due to "battery near end of service, in the red". It was stated that the lead was not replaced. The explanted generator¿s header was detaching from the generator and it was unknown by the or specialist if this happened during surgery when the surgeon was removing the lead or if it was like this prior to surgery. It was reported that the surgeon was pulling with forceps to pull the generator out and was unsure if it happened prior to or during the explantation, but it did appear that she was using some force to get the battery out. They did not conduct system diagnostics prior to surgery and only interrogated the device to get old settings. It was also alleged that the m106 battery that was explanted depleted quicker than expected. The device history record was reviewed, and it showed that the device passed all specifications prior to release. The device was also laser-routed during manufacturing. Data from the generator was reviewed, which showed that the battery voltage was dropping more quickly than expected as compared to the amount of charge that had been consumed. This was most likely related to the laser-routing process during manufacturing, which is known to leave debris on the edge of the printed circuit board, thus providing a leakage path for current from the battery. The explanted generator was received for analysis and analysis is currently underway but not yet completed and approved.
 
Event Description
Product analysis for the generator was completed and approved on 10/17/2017. Visual observations showed that the header was detached from the pulse generator case, which is not typical in a surgical procedure. It is very likely that the header was detached from the pulse generator case during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during or after the explant process. The pulse generator was opened. A visual assessment on the pcba, performed showed contaminates on the trimmed edge of the pcba (tab removed). No other visual anomalies were identified. During the bench interrogation, the pulse generator interrogated at a distance of one and one-quarter inches (spacer block) between the pulse disabled and eos warnings were set. The battery was removed. The printed circuit board assembly (pcba) was subjected to a postburn electrical test and results show that the pcba failed several electrical tests: r2 verification, supply current 2 ma/normal, supply current off, supply current off sense, magnet detection normal, magnet response, and trim diagon current. Fine grit sandpaper and isopropyl alcohol were used for the removal of the observed contaminates from the trimmed edge of the pcba. Based on the postburn electrical test results, the contamination that was observed on the trimmed edge of the pcba suggest probable electrical paths (resistive path) were established between the copper edges on the trimmed edge of the pcba, which contributed to the supply current conditions. No additional relevant information has been received to date.

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« Reply #144 on: June 13, 2019, 02:59:46 AM »

Model Number 106
Device Problems Detachment Of Device Component; Mechanical Problem
Event Date 11/02/2017
Event Type  Malfunction   
Event Description
It was reported that during a replacement surgery, the surgeon attempted to screw in the setscrew on the new generator with two separate screwdrivers, but he could not get the screw to click. The septum plug and screw then proceeded to fall out of the generator, so they had to implant a new generator. Reportedly, the set screw was turned in the correct direction, but it would not engage from the very first turn. There was no clicking sound at all and it wouldn¿t hold the lead securely in place. The suspect product was returned but product analysis has not been completed to date. No further relevant information has been received to date.
 
Event Description
Product analysis was completed on the returned generator on. Analysis found that the header septum cavity and the septum met dimensional specifications. Examination of the set screw identified indentation marks at the bottom of the set screw which shows that a lead pin or test resistor was secured with the returned set screw. Furthermore, the hex head was damaged with the hex socket rounded out, which can occur when the torque wrench is not fully engaged into the hex head. This damaged hex head would prevent the tightening of the set screw on the lead pin or the test resistor and may have contributed to the detachment of the set screw. No further anomalies were identified. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7062442
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« Reply #145 on: June 14, 2019, 05:57:36 AM »

Model Number 106
Device Problem Detachment Of Device Component
Event Date 10/23/2017
Event Type  Malfunction   
Event Description
It was reported that during a repositioning surgery, the septum plug came out of the generator and was unable to be secured in its original place. A new generator was placed instead. The explanted device has not been received by the manufacturer to-date.
 
Event Description
The explanted device was received by the manufacturer. Analysis is underway, but has not been completed to-date.
 
Event Description
Analysis was completed for the returned generator. The device output signal was monitored for more than 24 hours, while the pulse 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. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 2. 966 volts and was not in a depleted condition. The downloaded data revealed that 2. 772% of the battery had been consumed. The reported detachment of the septum plug was observed as the septum was not returned for evaluation. The header septum cavity meets specification. Therefore, a root cause for the condition could not be determined. 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=7042821
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« Reply #146 on: June 14, 2019, 05:58:30 AM »

Model Number 304-20
Device Problem Detachment of Device or device Component
Event Date 05/06/2019
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that high lead impedance was found while the patient was in the clinic and suspected to be a lead break. Output current was stated to be low. Patient had consult with surgeon and scheduled lead revision surgery. Information was received confirming the revision surgery took place. It was stated that during the replacement case, the lead pin was found in the generator cavity and the silicone portion of the lead was detached from the lead pin. Surgeon located the generator and found that it was not attached to the lead. Both the generator and lead were replaced. It was stated both the generator and lead would be sent back for analysis, but has not been received to date. It was stated that the wires were not abraded and was a clean detachment from the pin. It was also stated that there was no known trauma to the area and physician does not know what could have caused this. No additional relevant information has been received to date.

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« Reply #147 on: June 15, 2019, 11:12:04 PM »

Model Number 102
Device Problems Detachment Of Device Component; High impedance
Event Date 10/23/2017
Event Type  Malfunction   
Event Description
It was reported from an implant card that the patient had a full replacement. It was reported that the replacement was due to high impedance ¿intraoperative broken connection between battery and lead. ¿ clarification was provided through pictures received that the header was detached from the generator. System diagnostics prior to the replacement were not available. It was stated that the reason for the generator replacement was due to the high impedance and that at break was not viewable on x-ray. The detachment of the header from the generator was stated to be seen after the surgeon opened the pocket at surgery. The surgeon does not know the reason for the damage to the header. The explanted lead and generator have not been received for analysis to date.
 
Event Description
Per the physician, the explant devices were returned but have not been received by the manufacturer to date. It appears as though the device may have been lost in transit. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7045406
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« Reply #148 on: June 17, 2019, 04:16:52 AM »

Model Number 106
Device Problem Detachment Of Device Component
Event Date 10/18/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during the implant surgery for a patient, the torque wrench got stuck in the generator. While trying to remove the torque wrench the set screw came out with the wrench. A new generator was used and the surgery was completed. The generator that was not used was returned to the manufacturer however product analysis has not been completed to date. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Product analysis was completed on the returned generator. The septum plug and set screw that fell out of the generator were not returned to the manufacturer for analysis. The header septum cavity measured 0. 125 inches which met specifications. A set screw was inserted into the negative connector block and secured a bench lead with no issues. A comprehensive automated electrical evaluation showed that the device performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Unique identifier (udi) # - corrected information: the udi number on the initial report submitted should have been (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7023776
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« Reply #149 on: June 18, 2019, 12:29:54 AM »

Model Number 304-20
Device Problems Detachment Of Device Component; High impedance
Event Date 10/18/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was detected on the patient's device through both normal mode diagnostics and system diagnostics. Follow-up with the physician found that the patient's lead wire had reportedly dislodged and the patient was experiencing a burning pain in their neck. The patient was also experiencing an increase in auras. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
The treating neurologist indicated that they believed that the wire was dislodged because they could palpate it in the subcutaneous tissue. The patient's lead and generator were replaced. Product return is not expected. The replacement operative notes indicated that there was significant scar tissue in the patient's neck and it was unclear if a portion or the electrode was actually around the nerve. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7023835
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