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dennis100
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« Reply #390 on: February 10, 2019, 03:56:47 AM »

Model Number 102
Event Date 12/01/2014
Event Type  Injury   
Event Description
It was reported through clinic notes dated (b)(6) 2014 that the vns device has moved and is causing the patient pain. It was noted that this happened when her sister did chest compressions after a seizure. The generator is now down into the left breast tissue. Diagnostics showed the device was fine, with eos=yes. The patient had not had an increase in seizures and the physician felt that the patient having chest compressions was unnecessary and inappropriate and did cause the device migration. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Event Description
It was reported that the patient underwent generator replacement on (b)(6) 2015.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4383816
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dennis100
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« Reply #391 on: February 10, 2019, 03:58:05 AM »

Model Number 102
Event Date 10/06/2014
Event Type  Injury   
Event Description
Clinic notes were received indicating that the vns patient believed something was wrong with her lead during an office visit on (b)(6) 2014. The patient was experiencing neck pain, so the physician subsequently lowered the patient¿s device settings. During an office visit on (b)(6) 2014, the patient¿s device was tested and diagnostic results showed normal device function. The patient had a seizure in the office in which she was unresponsive and leaning her head back and forth with her eyes closed. No shaking or rhythmic movement was noted. The magnet was used and the seizure lasted approximately three minutes. The patient opened her eyes but was unresponsive for several minutes. The patient was unaware of the seizure. Since her last office visit on (b)(6) 2014, the patient had eight gtc seizures and had been to the er twice. The physician was questioning the battery status of the patient¿s device. A battery life calculation using the available programming history showed approximately three years remaining until neos = yes. The patient underwent generator replacement surgery on (b)(6) 2014. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.
 
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient¿s increase in seizures was due to the decrease in device settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377886
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dennis100
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« Reply #392 on: February 10, 2019, 03:59:30 AM »

Model Number 304-20
Device Problem Insufficient Information
Event Date 12/03/2014
Event Type  Injury   
Event Description
Additional information was received that the patient was referred for vns device explant due to chronic pain since implant, which was not resolved even though the device was disabled. The patient underwent a generator and lead explant surgery on (b)(6) 2015. The explanted devices were received by the manufacturer for analysis. However, analysis has not been completed to date. Additional information was received that the patient's diagnostic results have been within normal limits. Furthermore, the explant surgery was taken for patient comfort, not to preclude a serious injury.
 
Manufacturer Narrative

Event Description
Analysis of the explanted generator and lead was completed. Analysis of the generator showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the return lead was completed as well. Note that a large portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Furthermore, additional information was received that the patient's vocal cord paralysis has resolved since first being reported.
 
Event Description
It was reported on that the vns patient had left vocal cord paralysis following implant surgery on (b)(6) 2014 which required the patient to go to the emergency room. The patient did not have a prior history of vocal cord paralysis. Follow up with the patient's treating physician indicated that the believed cause for the left vocal cord paralysis was surgical trauma. The patient was referred to an ent.

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dennis100
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« Reply #393 on: February 11, 2019, 02:28:26 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
A patient reported that her vns vibrated every 3 minutes, and afterwards she then would experience pain and swelling in her throat. The patient requested the device be explanted. No additional relevant information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7187534
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dennis100
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« Reply #394 on: February 12, 2019, 03:28:03 AM »

Model Number 102
Device Problem Device Operates Differently Than Expected
Event Date 06/20/2014
Event Type  Injury   
Event Description
It was reported that the vns patient felt her generator moving and flipping in her chest which was causing burning sensations. The patient¿s device was tested and showed normal device function. The patient previously reported that her magnet was not aborting her seizures and that magnet mode stimulation was causing burning sensations in the chest. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
It was found from the surgeon's office who had originally implanted the generator in 2012 that the generator was secured with a non-absorbable silk suture during implantation.
 
Event Description
The patient's generator was explanted and replaced on (b)(6) 2015. The patient's device was discarded after explant and will therefore not be received for analysis.
 
Manufacturer Narrative

Event Description
It was reported that the patient underwent surgery to remove the generator from the chest pocket, and place it in the left shoulder. The patient experienced more discomfort following the repositioning of the generator. Additional surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4535345
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dennis100
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« Reply #395 on: February 12, 2019, 03:29:41 AM »

Event Date 01/26/2015
Event Type  Malfunction   
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed. Clinic notes were received indicating that the vns patient presented with new symptoms during an office (b)(6) 2015. The right side of the patient¿s lower face and upper neck was twitching which would occur for a few minutes and then stop. The patient also was having sharp pains on the left side of her head that occurred daily. High impedance was observed during the office visit and the patient¿s device was not disabled.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2015 and system diagnostic results revealed high impedance (dcdc ¿ 7). The patient¿s device showed lead impedance within normal limits (dcdc ¿ 2) at the previous office visit on (b)(6) 2014 the patient was referred for surgery but no known surgical interventions have occurred to date.
 
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=4532847
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dennis100
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« Reply #396 on: February 13, 2019, 03:07:06 AM »

Model Number 103
Event Date 12/01/2010
Event Type  Injury   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported that the vns patient was referred for surgery to explant her device due to pain that began in (b)(6) 2010. No known surgical interventions have occurred to date. The device was disabled in (b)(6) 2011 due to pain and the patient¿s preference. Review of the available programming and diagnostic history showed normal diagnostic results the date the device was disabled.

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dennis100
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« Reply #397 on: February 14, 2019, 02:25:36 AM »

Model Number 304-30
Event Date 11/23/2014
Event Type  Malfunction   
Event Description
Additional information was received that the patient is still experiencing ¿pulling¿ sensation and discomfort in his left neck area. The device is currently off.
 
Event Description
It was reported that, for the past 1. 5 months, the patient has had random episodes of sudden discomfort from the generator site up to the left side of his neck that is progressively worsening and occurs 5 times per day. The nurse practitioner has adjusted vns but the discomfort doesn't seem to reduce and might not be associated with the stimulation. The patient experiences discomfort when he is lying still, sitting, or standing, doesn't seem to have any trigger. Patient was contacted several times to visit the clinic to adjust vns or disable vns if needed. But patient has not been able to visit due to transportation issues. Patient was last seen in (b)(6) 2014 and patient was set to comfortable settings at that time. No issues were reported with the device during this visit. Patient has been provided with medications for the pain meanwhile. X-rays were received with a note stating that the patient has been complaining of severe neck pain that radiates into his left clavicle. The pain was reported to be independent of vns activation and he does have pain when he turns his head. Per the nurse practitioner, there is a possible mircrofracture of the lead and the vns was disabled. The patient¿s next appointment is on (b)(6) 2015. The x-rays were reviewed and there did not appear to be any lead discontinuities in the portion of the lead that could be visualized. It was noted that the strain relief bend did not appear to be present. The lack of strain relief bend could possibly be a factor in the patient¿s pain. However no conclusions can be drawn regarding the exact cause of the pain. Attempts made for the diagnostic test results were unsuccessful to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.
 
Event Description
Additional information was received that the patient's device diagnostics were checked on (b)(6) 2015 and that the results were within normal limits. It was also reported that the patient's pain was slightly better.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4639353
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dennis100
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« Reply #398 on: February 14, 2019, 02:26:16 AM »

Model Number 102
Event Date 01/07/2015
Event Type  Injury   
Event Description
It was reported from the physician's office that the patient hasn't actually been seen since 2013. The nurse indicated that the reason for replacement is not actually known since the patient has not been seen and the mention of throat pain and shortness of breath was a serious issue. She had no more information to provide about the adverse events mention since these occurred a couple of years ago she is no longer their patient. She did not know the patient's current physician. This was all the information provided.
 
Event Description
It was reported that the vns patient underwent surgery to explant her device due to lack of efficacy. Follow-up indicated that the reason for surgery was throat pain and dyspnea. No further information relevant to the event has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4515632
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dennis100
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« Reply #399 on: February 15, 2019, 04:01:52 AM »

Event Date 01/01/2011
Event Type  Injury   
Event Description
An anonymous vns patient reported that she had lost her voice for the past four years and was having worsening seizures and uncontrollable pain. The relationship of the patient¿s events to vns is unknown.
 
Manufacturer Narrative

Manufacturer Narrative
Date of this report; corrected data: the previously submitted manufacturer report inadvertently provided an incorrect date for this field. This report is being submitted to correct this date. Date received by manufacturer; corrected data: the previously submitted manufacturer report inadvertently provided an incorrect date for this field. The reported date should have been 02/25/2015.

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dennis100
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« Reply #400 on: February 15, 2019, 04:02:45 AM »

Model Number 103
Event Date 09/01/2012
Event Type  Malfunction   
Event Description
On (b)(4) 2013 it was reported that the vns patient had been experiencing 3-4 episodes of severe shortness of breath within the last 6 months. These events lasted approximately 30 seconds and she had great difficulty getting a full breath. She cannot reproduce these events and is unsure of any pattern or triggers that could possibly be causing these events. The patient also had a complaint of throat pain in (b)(6) 2012. At that time her settings were lowered. The patient's settings prior to the (b)(6) 2012 complaint of throat pain were output=1. 5ma/pulse width=250usec/frequency=20hz/on time=30sec/off time=1. 1min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=250usec. After the (b)(6) 2012 visit, the patient's settings were changed to the following to alleviate the throat pain: output=1. 5ma/frequency=15hz/pulse width=130usec/on time=30sec/off time=1. 1min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=130usec. The patient was interrogated during the (b)(6) 2013 visit, then a system diagnostics test was performed, and then upon second interrogation, the device showed an error message stating "programmed current is possibly not being delivered at the specified level (possibly limited by battery voltage, lead impedance, or other reason). Reprogram the pulse generator to a lower output current and a wider pulse width. " there was no impedance issues, output current errors, or elevate impedance values when running the diagnostics. The patient was re-programmed to a wider pulse width, from 130 usec to 250 usec, per the instructions of the error message (both normal output and magnet output) and the error seemed to resolve itself. No changes were made to the output current or the rest of the patient's settings. Diagnostics were performed again and all results were within normal limits. A final interrogation was performed without an issue. The patient left the clinical visit at settings of output=1. 5ma/pulse width=250usec/frequency=15hz/on time=30sec/off time=1. 1min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=250usec. The manufacturing records for the generator were reviewed and the device met all specifications prior to distribution. It was later clarified that the issue has resolved itself. Also, the patient's shortness of breath only happened 3-4 times over a 3-4 month span. It was unclear if the patient's pain and shortness of breath coincided with stimulation and if they had resolved. It was stated that x-rays were taken and would be sent to the manufacturer for review but they have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3079679
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dennis100
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« Reply #401 on: February 16, 2019, 03:07:02 AM »

Model Number 302-30
Event Date 07/01/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Clinic note dated (b)(6) 2015 note that the patient was undergoing surgery due neck pain at the left side of the neck. Surgical notes indicate that the surgery was unremarkable. It was reported that the patient did not have another vns system placed because the patient was "epilepsy free". The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Clinic notes were received dated (b)(6) 2015 that indicated that a patient implanted with a vns device has been experiencing pain at one of their lead "anchor" sites since he was last seen in (b)(6) 2014. The pain has persisted, the patient takes advil but is still able to complete daily activities. The patient was referred for surgery for "removal of the anchor. " additional information was received that reported they were having their vns removed although unclear if whole device or just the anchor. Their pain is reported to be located in their neck and caused by a disconnected lead. It is unknown whether their was any trauma that caused the event.
 
Event Description
Analysis of the returned generator and lead was completed. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation cannot be made on that portion of the lead. There were no performance or any other type of adverse conditions found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4588059
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dennis100
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« Reply #402 on: February 16, 2019, 03:07:56 AM »

Model Number 102
Event Date 02/18/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2015 the patient¿s generator was explanted. It was reported that the removal was ¿painful¿ but this may be suspected to be just a difficult removal although it is unclear. No other details were provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4613666
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dennis100
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« Reply #403 on: February 16, 2019, 03:08:55 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2015
Event Type  Injury   
Event Description
The physician reported that the nocturnal seizures were unusual for the patient, however she has still experienced an overall decrease in her seizures compared to before vns. She also said that there was no way of telling if these seizures are related to vns or not and that they were not witnessed.
 
Event Description
It was reported that the patient began feeling pain and a pulling type sensation in her neck. It was noted that there was no trauma. X-rays were taken and sent for review. Per the x-rays, the generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appear in proper alignment. Strain relief bend was present but not per labeling. No strain relief loop was present. Two tie-downs were observed but were not placed per labeling. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Part of the lead was behind the generator and could not be assessed. The presence of a micro-fracture in the lead cannot be ruled out. As the entire lead could not be assessed, continuity in that portion of the lead cannot be confirmed. Based on the x-rays received, the cause for the pain and lead pulling sensation could possibly be due to the lack of proper strain relief. The patient was seen by the physician and the diagnostics (systems and normal mode) read normal. The doctor upped the output current to 1. 0ma and reduced the pulse width to 250 to see if it would help with the side effects she was having. It was noted that the patient had been experiencing pain in her chest and a ¿pulling¿ sensation when the device is on. Since the doctor saw her last, she had a cluster of nocturnal seizures and now she is noticing more effect on her voice and pain when the device is on. She went to see an ent who investigated and was able to determine that her vocal cord was not moving when the device was on. The patient doesn¿t want to turn the device off, as she feels it is really helping with her seizures and she is able to ¿tolerate¿ the effects. The physician also mentioned the patient also has horners syndrome on the left side.
 
Manufacturer Narrative

Event Description
The ent could not tell if the device was stimulating or not during his evaluation of the patient, so he could not comment on any dynamic changes in vocal cord function. The physician stated that the improvement in vocal cord function may have been due to the decrease in output current or because the device was not stimulating at the time of evaluation. The ent felt that it was reasonable to keep the patient's vns on and doubted that there would be any progressive decline in vocal cord function. No further relevant information has been received to date.
 
Event Description
On (b)(4) 2015, it was reported that the patient's painful stimulation is worsening (erratically, and more noticeable when active) as well as her voice hoarseness becoming worse and sometimes painful. This has been noticeable over the last 4-5 months. She also reports that since this time, she has noticed that several times, she has had a jolt from the stimulation and it feels like it takes her breath away. This most recently happened in (b)(6) 2015. The nurse mentioned that the diagnostics back in (b)(6) 2015 were within normal limits.
 
Event Description
An update was received on 06/24/2016 regarding the patient's voice issues. The patient was still experiencing voice issues, which were also occurring during off-times. The ent was concerned about possible vagus/laryngeal nerve damage because the issue is still occurring when the device was not stimulating. The patient's previous settings were decreased two separate times to alleviate the voice issues. The patient did not want to try a temporary disablement due to the possibility of an increase in seizures. The ent consult notes stated that the patient's laryngeal function was affected by vns, but the function and voice was improving. The notes did not explicitly mention laryngeal nerve damage. The patient's settings were recently adjusted to help with tolerability. The patient also reported having painful stimulation with magnet mode, but she has had fewer and milder seizures than pre-vns and is overall happy with vns therapy. No further relevant information has been received to date.

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dennis100
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« Reply #404 on: February 17, 2019, 06:26:57 AM »

Model Number 302-30
Event Date 01/01/2015
Event Type  Injury   
Event Description
Analysis of the generator was completed on 03/05/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.
 
Manufacturer Narrative

Event Description
Initially it was reported that the patient was scheduled for generator and lead replacement for an unknown reason. It was reported that the generator was replaced due to end of service and that it was believed that the patient experienced an increase in seizures, but the pre-vns baseline frequency is unknown. The patient requested to have the lead replaced due to the lead having become more prominent over the last year and pain in the neck when turning head in different directions for 2 weeks prior to surgery. The reason for the protrusion is unknown. Device diagnostics were within normal limits. It was reported that the lead was replaced to preclude a serious injury and for patient comfort. The pain and protrusion resolved following generator and lead replacement surgery. The explanted lead was discarded during surgery. The explanted generator was returned for analysis on 02/10/2015. Analysis is underway, but has not been completed to date. No additional relevant information has been received to date.

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dennis100
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« Reply #405 on: February 17, 2019, 06:28:08 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2017
Event Type  Injury   
Event Description
It was reported by the patient that she felt like she was having a heart attack and questioned if the vns would make you feel like that. It was explained to the patient that vns does not make you feel like that. The patient took some of her husband's nitroglycerin, which made her feel better. She explained that she still felt that she had a knife stabbing her in the shoulder and her jaw hurt when using the vns magnet. The patient was urged multiple times during the call to speak with emergency care if she suspects a heart attack. The patient insisted on seeing a neurologist. It was later reported the vns was programmed off. The device history records for both the lead and the generator were reviewed and they had passed qc review prior to distribution. Attempts for further relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician's office. It was explained the patient had come in the month prior complaining of headache, left arm numbness, nausea, and chest pain. The device was programmed off and x-rays were performed. Nothing remarkable on the x-rays; the x-rays were normal. It was noted the patient came back a few days later and the physician stated since the patient was doing fine with the vns programmed off, they decided to leave it programmed off. No diagnostics were performed and it was not noted if the battery was low or not. A battery life calculation was performed showing the vns should have approximately 2 years remaining until neos = yes (near end of service), so it is not suspected the issues are due to a depleted battery. Additionally, the information available in the in-house programming history database was reviewed, and there were no anomalies observed with the patient's vns. However, the last diagnostic tests available were performed back in 2012.

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« Reply #406 on: February 19, 2019, 03:47:35 AM »

Model Number 304-20
Event Date 05/31/2012
Event Type  Malfunction   
Event Description
Analysis of the explanted generator was completed on 06/02/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the explanted lead was completed on 06/04/2015. Other than the typical wear and explant related observations, no anomalies were identified in the returned lead portions.
 
Event Description
It was reported that the patient feels pain at the generator site up to the neck area. It was reported that it is unclear whether or not the pain occurs with device stimulation. There has been no falls or trauma that may have caused the pain. Device diagnostics were within normal limits (3337 ohms). Clinic notes dated (b)(6) 2012 note that the patient has some vague complaints of neck pain over his left side, moving down to his left arm and leg. It was noted that the patient describes the pain at sharp in nature and that the patient attributes the pain to vns. Clinic notes dated (b)(6) 2015 note that the patient is having significant discomfort on his left side with vns stimulation. It was noted that the physician believes the generator and lead need to be replaced. The patient underwent generator and lead replacement. The implant card indicated that the generator and lead were replaced due to lead discontinuity and adverse event. No additional relevant information has been received to date.
 
Event Description
The explanted lead and generator were returned for evaluation. Analysis is underway but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4723453
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« Reply #407 on: February 20, 2019, 12:18:59 PM »

Model Number 303-20
Event Date 08/01/2014
Event Type  Injury   
Event Description
The lead was returned for analysis on 04/24/2015. Operative notes state that the electrode appeared to be in good shape throughout its course. It seemed to have good adhesion and attachment to the vagus nerve. There were no obvious flaws or problems that were identified. Analysis of the device is underway but has not been completed to date.
 
Event Description
Clinic notes were received dated (b)(6) 2015. Notes mention that the patient was seen for follow-up regarding her neck pain associated with vns. The patient states that swiping the magnet causes uncontrollable pain. Today he reduced her magnet settings to match the normal mode of 1. 75ma, 30sec, 250 pulse width. Normal mode diagnostics were ok. The patient noted severe pain in the areas where her vns wire seemed to protrude from her neck. The physician repeated the x-ray of her neck and compared to her prior x-ray and showed no change. The patient feels the vns has shifted. The patient had a referral in place to have the surgeon evaluate vns due to the migration focal pain and to evaluate to see if there needs to be repositioning of the device. The physician stated that way the wire is looped is very uncomfortable and has been ongoing since insertion but recently the issue is worse. The lead was replaced on (b)(6) 2015. The explanted device has not been received to date.
 
Event Description
Product analysis for the explanted lead was completed and approved on 05/20/2015. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4707673
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dennis100
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« Reply #408 on: February 21, 2019, 02:05:46 PM »

Model Number 102
Device Problems Migration or Expulsion of Device ; Unexpected Therapeutic Results
Event Date 01/01/2015
Event Type  Injury   
Event Description
Analysis of the generator was completed on 04/15/2015. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The generator performed according to functional specification. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 04/14/2015. 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 typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report.
 
Event Description
It was reported that the patient was not tolerating the system and would undergo explant. The patient reported that the device was programmed off in 2008 due to lack of efficacy. The patient reported that the generator site is currently tender, sore and itches and she can see the shape of the device under her skin. The patient also indicated that she can feel the lead electrode pushing up against the skin like "it wants to poke out". The patient reported that the seizures are pre-vns baseline frequency. The patient indicated that she wants the device explanted. The patient underwent generator and lead explanted due to pain and hoarseness. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4674518
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« Reply #409 on: February 21, 2019, 02:06:42 PM »

Model Number 103
Event Date 06/20/2014
Event Type  Injury   
Event Description
It was reported that the patient's device was disabled due to uncontrollable coughing. It is unknown whether or programming the device off was to preclude a serious injury. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Further follow-up revealed that the device was programmed off, so that the patient could undergo monitoring for the coughing. The device was subsequently programmed back on. The patient underwent device explant on (b)(6) 2015 at the request of the patient¿s caregiver due to pain and dyspnea. The physician indicated that the surgeon would not have been performed had the caregiver not requested and the vns was functioning as intended. The explanted generator has not been received for analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4698038
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« Reply #410 on: February 22, 2019, 08:15:56 AM »

Model Number 302-20
Event Date 12/01/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s generator had migrated to the left armpit which was causing discomfort and pain. Clinic notes were received indicating that the physician observed the generator migration during an office visit on (b)(6) 2014. Diagnostic results from the office visit showed normal device function at that time. Follow-up revealed that the patient returned to the office on 04/06/2015 due painful stimulation that began approximately two week before the visit. The patient¿s device was tested and diagnostic results revealed high impedance. The patient¿s device was subsequently disabled and the pain subsided. The patient continued to have discomfort and stated that he could feel the device poking him under his skin. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have not been returned to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
The explanted lead and generator were received, and analysis is underway but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contributed to a death or serious injury.
 
Event Description
Analysis of the generator was completed on (b)(4) 2015. Electrical test results showed that the pulse generator performed according to functional. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead was completed on (b)(4) 2015. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 385mm portion quadfilar coil 1 appeared to be broken approximately 12mm from the electrode bifurcation. During the cleaning process a coil strand became detached from the electrode (mating) end of the quadfilar coil 1 coil break. Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break (found at 12mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The fourth broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the electrode (mating) end of the quadfilar coil 1 coil break (found at 12mm) and identified the area on three of the broken coil strands as being mechanically damaged with pitting which prevented identification of the coil fracture type. Evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture was observed on one of these broken coil strands. The fourth broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and 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. 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. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4669616
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« Reply #411 on: February 22, 2019, 08:16:35 AM »

Model Number 302-20
Event Date 05/09/2011
Event Type  Injury   
Event Description
It was initially reported by the epileptologist that the patient was to undergo a prophylactic generator replacement, and at the same time have his lead released from scar tissue. Additional information was received through an implant card indicating that the patient's lead was replaced and the patient had been experiencing coughing, tightness in the lead, and difficulty breathing. A review of the patient's history showed that the patient was implanted in 2006. The patient had started experiencing pain and tightness in his neck, following implant. This resulted in a procedure to release his lead wire from scar tissue in (b)(6) 2009. At that time, the procedure was performed for patient comfort. Follow up with the surgeon revealed that the patient's pain and tightness had reoccurred approximately a year after the previous surgery. The symptoms had gradually worsened, until it caused the patient pain and coughing when he turned his head to the right. During the procedure to loosen the lead wire from the scar tissue, the surgeon noticed damage to the "lead sheath" so he replace the lead wire. He indicated that the patient had developed severe fibrosis which entrapped the cable causing the pain, coughing, and discomfort. The fibrosis was also restricting the patient's neck motion. The surgeon stated that the procedure was performed primarily for patient comfort, but also potentially to preclude a serious injury. Follow up for additional information regarding the damage to the lead has been unsuccessful to date. The explanted products have not been returned to the manufacturer for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2129926
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« Reply #412 on: February 23, 2019, 02:39:41 AM »

Model Number 302-20
Event Date 03/04/2015
Event Type  Malfunction   
Event Description
It was reported that the vns patient presented with neck pain. The patient¿s device was tested and diagnostic results showed high impedance. The patient¿s device was subsequently disabled. Since device disablement, the patient experienced a seizure while previously being seizure-free. Follow-up revealed that high impedance was observed on both normal mode and system diagnostic tests. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to high impedance. The explanted devices have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator and lead was completed. The generator performed according to functional specifications. There were no anomalies found with the pulse generator. Analysis confirmed discontinuity of the positive quadfilar coil in the body region of the returned lead portions. An abraded opening of the positive inner tubing was observed near the break area. Scanning electron microscopy was performed on the connector end of the quadfilar coil break and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting. Pitting was observed on the coil surface.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4651958
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« Reply #413 on: February 23, 2019, 02:40:32 AM »

Model Number 103
Event Date 01/01/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient was experiencing pain at the electrode site and a lead pulling sensation. The physician observed that the patient¿s generator had migrated lower down the patient¿s chest and that the lead was protruding at the neck. The tension on the lead could be visualized from the neck to the clavicle. It was noted that the patient was very thin. X-rays were provided to the manufacturer for review and found to be unremarkable. The patient underwent surgery on (b)(6) 2015 and the surgeon noted that no suture was securing the generator. The surgeon stated that the suture either dissolved or had broken. The surgeon elected to replace the generator prophylactically and implanted the replacement generator higher up the patient¿s chest.
 
Event Description
It was reported that diagnostics were taken immediately before replacement of device and the impedance was good with a value of 2709 ohms. Diagnostics were taken after the device was replaced and the new device was connected to the patient's current lead. Diagnostics were taken once the new generator was implanted and the impedance was good with a value of 2546 ohms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4654528
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« Reply #414 on: February 23, 2019, 02:41:11 AM »

Model Number 302-20
Event Date 03/12/2015
Event Type  Malfunction   
Event Description
It was reported that the vns patient had been experiencing neck pain. The patient¿s device was tested and system diagnostic results revealed high impedance (impedance value ¿ 6525 ohms). No known surgical interventions have occurred to date.
 
Event Description
An implant card was received indicating that the patient underwent generator and lead replacement surgery on (b)(6) 2015 due to battery depletion and lead discontinuity. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.
 
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=4657106
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« Reply #415 on: February 23, 2019, 02:41:57 AM »

Model Number 302-20
Event Date 03/26/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient had presented a sharp pain in the left side of the neck and pulling sensation. The patient did not perceive the stimulation and she could not indicate whether the pain occurred with stimulation or not. The settings were programmed at 1. 5ma, 25hz, 130usec, 30secs on and 5mins off. The patient has dystonia and moves her neck quite a lot. X-rays were recommended but the patient did not wish to undergo any further surgical revision and preferred to have the generator disabled. Additional information was received indicating that the patient was implanted for depression. The pulse generator vns was disabled as the patient was experiencing severe discomfort. The patient wishes to undergo vns explant surgery because she believes that her cervical dystonia/torticollis is being worsened by vns. It was reported that the patient presented a severe pain episode caused by the lead, which seemed to be protruding more than it had done previously. It was reported that the patient also presented breathing difficulties, loss of some vision in one eye, severe pain in the middle of her back and abdominal pain which was relieved by the application of plasters. It was believed that these symptoms were related to the patient¿s depression. Surgical intervention for the explant of the vns system is expected but it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4804054
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« Reply #416 on: February 24, 2019, 09:22:17 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
Information was received that the patient's seizure increased from (b)(6) to (b)(6) 2017. Vns was returned to original settings by april after being turned off for surgery few months back. Yet the seizures are still worse currently. Per the physician, the relation of the seizures to vns is unclear. Patient's magnet swiping technique was observed to confirm that it is effective in initiating magnet stimulation. Normal mode diagnostic test results were provided with a dcdc - 5. Patient's device was disabled for patient's hysterectomy. Following that, the settings were titrated up to 2. 75 ma. The patient experienced pain in the throat which went away when the settings were decreased to 2. 5 ma. Since then the patient noticed that vns has not helped with her seizures and wanted it removed. Patient saw a neurosurgeon, who recommended that the vns be programmed off to see changes in seizures before removing. The patient did receive benefit from vns initially but has had a lot of stress. The nurse practitioner mentioned that she can't say the increase in seizures is directly related to vns. The seizure rate in comparison to pre-vns baseline is unknown.
 
Manufacturer Narrative

Event Description
Per the neurologist's note, patient is receiving benefit from device. No known surgical interventions to remove the vns has occurred to date.
 
Event Description
Clinic notes were received for patient, who would like to have her device removed, because she feels she no longer is receiving efficacy from the therapy. Notes dated (b)(6) 2017 indicate that patient's seizure frequency is worse than before over the last several months. Patient reported that the use of the magnet has had no effect in reducing seizure frequency or aborting seizures. Since patient's visit in (b)(6), patient has ben seen several times for vns adjustment. In (b)(6) visit, patient noted that she had increased frequency of seizures and that she has had multiple different types including drop events, convulsions, and starring/spacing. Patient cannot identify any changes in her life or medication use to correspond with this worsening. Patient also tried cbd oil and found it to be somewhat helpful. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6822371
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« Reply #417 on: February 24, 2019, 09:26:40 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that this patient did not think the vns was helping with seizure control and therefore the device was turned off in (b)(6) 2018. Now the patient is having pain on the left side of their neck and chest and therefore would like the device removed. Multiple attempts for relevant information were made, but no information has been received to date. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7921839
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« Reply #418 on: February 25, 2019, 02:36:34 AM »

Model Number 103
Event Date 03/23/2015
Event Type  Injury   
Event Description
The patient had generator and lead replacement surgery on (b)(6) 2015 due to pain and painful stimulation. At that time, the physicians reported that the surgery was for patient comfort reasons and not to preclude a serious injury. The implant card reported that lead impedance was okay after replacement surgery. Additional information was later received that patient complained of pain after the surgery. Initially at post-op appointment on (b)(6) 2015, the notes recorded no post-operative complications and no patient complaints. The scars/incision sites were reported to be healed nicely. Later on (b)(6) 2015, the notes reported that the patient reported having continued problems with a burning sensation and a sensation of electricity around the vns site. The pain/discomfort did not improve after full replacement surgery. She could not tolerate this continued problem. The clinic notes from (b)(6) 2015 reported that the patient presented after full replacement complaining of pain in the area of the vagus nerve stimulator and neck. The patient reported that the pain was persistent if the device was not on. As a result, she wanted the device removed. The patient's device was programmed off due to the pain, and the physician assessed that it needs to be removed due to pain experienced even with the device off. The patient was referred for removal of the vns. The manufacturer¿s field clinical engineer attended the explant surgery on (b)(6) 2015. Explant of the generator and lead occurred on (b)(6) 2015, and the explanted devices were discarded. As a result, product analysis is unable to be performed.
 
Event Description
It was reported that the patient has had pain in the vns region of the neck since the first date of initial implant. Therefore, it was felt that since the patient was still complaining of pain with the replacement vns system, that the physician did not see any reason for it to remain implanted. It was felt to be removed more for patient comfort reasons.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Describe event or problem: the initial report inadvertently did report this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4760249
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« Reply #419 on: February 25, 2019, 02:37:33 AM »

Model Number 304-20
Device Problems Generator; Device Operates Differently Than Expected
Event Date 08/25/2014
Event Type  Injury   
Event Description
It was reported by the patient that the vocal cord paralysis was permanent. The explanted generator was requested for evaluation; however, it was discarded and cannot be returned.
 
Event Description
It was reported by the patient that she has experienced nerve damage in her face, and paralysis on the left side of her face as a result of vns surgery. The patient reported swelling on her neck with the nerve damage to her face. The patient's physician and cardiologist have reported they believe the tachycardia to be pre-existent and not related to vns. Attempts for additional information have been unsuccessful to-date.
 
Manufacturer Narrative
Describe event or problem, corrected data: it was inadvertently reported on the initial report that the physician attributed the tachycardia to vns. Brand name, corrected data: the suspect device was inadvertently reported as the generator and was the brand name was reported incorrectly on the initial report. Type of device, corrected data:the suspect device was inadvertently reported as the generator and the type of device was inadvertently reported incorrectly on the initial report. Model, serial number, lot number, expiration date, corrected data: the suspect device was inadvertently reported as the generator and the model, serial number, lot number and expiration dates were inadvertently reported incorrectly on the initial report. Explanted date, corrected data: the suspect device was inadvertently reported as the generator and an explant date was incorrectly reported on the initial report. No known surgery to explant the suspect lead device has occurred to-date. Evaluated by mfr, corrected data: it was inadvertently reported on follow-up #1 that the device was not returned to the manufacturer when it had already been correctly reported on the initial mdr, resulting in a duplicate statement. Device manufacture date, corrected data: the suspect device was inadvertently reported as the generator and the device manufacture date was incorrectly reported on the initial report. Evaluation codes, corrected data: the conclusion code was inadvertently reported incorrectly on the initial report.
 
Event Description
The patient has stated that the generator was removed because her left vocal cord was clipped during the surgery and has caused voice issues. The patient reported pain in her neck and stated she had no feeling on the left side of the face as a result of the surgery, which has not fully resolved to-date. Attempts for additional information have been unsuccessful to-date.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient underwent surgery on (b)(6) 2015 to explant the generator due to vocal cord paralysis and tachycardia which the physician attributed to vns. The lead was not explanted during the procedure. The patient began experiencing these issues following initial implant surgery on (b)(6) 2014. No further information relevant to the event has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4762712
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