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dennis100
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« Reply #60 on: September 21, 2017, 12:32:32 AM »

Model Number 103
Event Date 05/15/2012
Event Type  Injury   
Event Description
Attempts for additional information have been unsuccessful. Surgery is still likely, but has not occurred.
 
Event Description
On (b)(6) 2012, a surgeon's office reported that they had received a phone call from a patient's mother. The mother reported that the vns patient had been experiencing continual hoarseness, choking, blue lips, face redness, vomiting, and inflammation at the surgical site. The patient's mother stated that the device was turned on at the date of surgery. At first, the patient's coughing was mild; however, as the day progressed, the coughing and choking became worse. She reported that the patient was feeling anxiety and, as a result, pacing due to the side effects. She also stated that the patient feels "like her head is going to explode. " the mother also reported that the patient has not had a grand mal seizure in two years; however, she has had two grand mal seizures since implant and went to the emergency room. (the date of the hospital visit is unknown. ) the patient went in to see her neurologist and the settings were decreased; however, the symptoms continued. The patient returned to the neurologist on (b)(6) 2012 and the device was disabled; however, the magnet output current was intentionally not programmed to 0 ma, and the patient and mother were told to swipe the magnet if they felt a seizure coming on. On (b)(6) 2012, a physician's office reported that they had spoken to the patient's mother on this date. The mother reported that the neck incision was swollen (there was a somewhat hard bump there that hurt when touched). She also stated that each time the device stimulated, the patient felt like she was being choked, turned red, the lips turned blue, and she would vomit. When the patient spoke, the mother noticed that the nerves were "pulling at her upper lip. " on (b)(6) 2012, a voicemail was received from the neurologist. He stated that he saw the patient and disabled the output current, expect for magnet stimulation. The physician stated that the patient was problematic and could not tell if the patient had a lot of anxiety or if the events were actually occurring. He stated that the patient reported choking; however, he did not see this and thought her swallowing was normal. He also stated that the patient reported tightness in her throat and coughing. In addition, he stated that there is a little swelling at the neck incision that was typical for surgery and not alarming. On (b)(6) 2012, the neurologist reported the patient's wounds were fine; however the patient was very anxious about the device and wanted it removed. The neurologist suggested using vitamin e cream for the wounds and giving the healing process a chance. The neurologist believed that the device was still programmed to only deliver magnet stimulation. The neurologist also believed that it would be best to leave the device in for a few months, especially after wound healing. On (b)(6) 2012, a surgeon's office reported that the patient's anxiety made the mother become anxious and any little pin prick sensation caused them to call everywhere. Surgery is likely but has not taken place to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2638613
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dennis100
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« Reply #61 on: September 23, 2017, 03:15:07 AM »

Event Date 05/31/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6), 2012, it was reported that the patient was inspected at age thirteen. The device was turned off prior to this physician's care. The patient came to the practice with her device off. The patient's vns was never assessed by this physician due to the fact that she had it off prior to their care. The location of pain was unknown. It was also stated that the patient never tolerated vns therapy, even at minimal settings. The vns stimulation caused increased anxiety. The device was disabled prior to the patient's first visit with the physician in 2008.
 
Event Description
It was initially reported that this vns patient was scheduled for generator and lead explant. The reason for explant was not provided. The patient underwent explant surgery on (b)(6), 2012. On (b)(6), 2012 a vns treating physician reported that the patient's generator was explanted due to discomfort and pain when lying on the left side. The device has been disabled for several years due to lack of efficacy. The patient has since undergone resective surgery for epilepsy. The lead was explanted as a result of a patient/surgeon decision. Attempts for additional information, product information, and product return have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2683633
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dennis100
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« Reply #62 on: October 19, 2017, 01:02:58 AM »

Model Number 104
Event Date 07/09/2013
Event Type Malfunction
Manufacturer Narrative
Review of device history records. Review of the generator device history records confirmed all quality tests were passed prior to distribution.

Event Description
Additional information was received that product analysis was completed on the generator and lead. The pulse generator was interrogated at multiple orientations adjacent to the programming wand, with a one inch spacer between the pulse generator and the programming wand. The pulse generator interrogated at all orientations. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications as defined in ets 28-0000-3300/2. The battery, 2. 952 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 15. 884% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sulphur, sodium, magnesium and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurements taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Event Description
It was initially reported that the patient was having her device explanted due to having pseudo-seizures and anxiety. The physician did not think the patient was a good candidate for vns therapy originally. Clinic notes dated (b)(6) 2013 reported that the patient¿s vns generator was checked and it appeared to be ¿malfunctioning. ¿ the physician reported in the notes that excessive stimulation was provided, and he was unable to program the settings down. Therefore, the vns magnet was taped over the device to disable the stimulation. The physician noted that it was desired to have the device explanted anyway, so she was referred for surgery. Previously on (b)(6) 2013, the patient asked to have her vns settings turned down. The physician turned the settings down to 0. 75 ma with the plan to turn it off at the next visit in two months. Patient was admitted to medical center on (b)(6) 2013 and discharged on (b)(6) 2013 due to recurrent seizures. Eeg confirmed that the patient does not have epileptic seizures. Attempts to the physician for additional information on not being able to program the device settings down have been unsuccessful to date. The patient was originally implanted with vns in 2001 but had generator replacement in 2010. The patient had generator and lead explant on 07/26/2013. The explanted products were received by the manufacturer on 08/01/2013. However, analysis has not been completed to date. The return product form indicated reason for explant was "patient desired. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3267316
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dennis100
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« Reply #63 on: October 21, 2017, 12:54:43 AM »

Model Number 102R
Event Date 04/09/2012
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2012 indicate that the patient experienced an increase in seizures the month prior. It was noted that the patient had no change in his schedule, no missed medications, and experienced good sleep as usual with no sickness or recent illnesses, but had more anxiety last month. It was noted that the patient experienced 5 seizures the month prior. It was noted that the vns current was increased, the frequency was increased and the off time was decreased to 1. 1 min. It is unknown whether or not the increase in seizures is above the patient's pre-vns baseline frequency. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3427211
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dennis100
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« Reply #64 on: October 24, 2017, 12:40:29 AM »

Model Number 102
Event Date 08/26/2013
Event Type Malfunction
Event Description
On (b)(6) 2013, it was reported that the physician was unable to interrogate the patient's vns device. A battery life calculation was performed which found the vns generator had 1. 46 years until end of service. Troubleshooting was later performed on the programming system which found that the programming system was working fine. The patient's device was last successfully interrogated in 2009. The patient's device has not been interrogated since then. Clinic notes were received which indicate the patient needs a vns replacement due to the vns not working. Additionally, the patient has been experiencing an increase in depression. Per clinic notes dated (b)(6) 2013, the patient was admitted to the hospital on (b)(6) 2013 due to depression and suicidal thoughts. The patient stated that she has had no suicidal thoughts, but continues to have anxiety and stress.

Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3520174
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dennis100
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« Reply #65 on: November 03, 2017, 02:56:13 AM »

Model Number 102
Event Date 06/21/2007
Event Type Injury
Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014. The explanted device has not been returned to date.

Event Description
Clinic notes were received for the vns patient's office visit with her psychiatrist on (b)(6) 2007. The patient had been experiencing an increase in depression, anxiety, and mood lability. The patient did not experience any improvement with the previous changes to her device settings. The patient did not experience any pain or discomfort from her device. The patients output current was increased during the office visit. The patient's device was programmed on for the first time at the patient's device was programmed on for the first time at the patient's previous office visit on (b)(6) 2007. It was noted that an attempt was made to taper the patient's medication during the office visit on (b)(6) 2007, which may have contributed to the patient's increased symptoms. The patient's medication was restarted and increased during the office visit on (b)(6) 2007. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
Describe event or problem, corrected data: the supplemental report #1 inadvertently reported this data, but it was not related to the events previously reported in this mfg report #. Suspect device explant date, corrected data: the supplemental report #1 inadvertently reported this data, but it was not related to the events previously reported in this mfg report #.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4092195
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dennis100
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« Reply #66 on: November 07, 2017, 01:53:35 AM »

Model Number 102
Event Date 09/01/2014
Event Type Injury
Event Description
It was reported that the recently implanted vns patient had been experiencing an increase in seizures and a new seizure type for the past week. On (b)(6) 2014, the patient had a seizure that lasted for approximately 35 minutes and was taken to the er. The patient was given medication and admitted to the icu. The patient¿s seizures were determined to be non-epileptic but a new type for the patient. It was noted that vns had improved the patient¿s epileptic seizures. Follow-up revealed that the patient¿s device was tested and diagnostic results showed normal device function. The patient¿s device pulse width was decreased from 500usec to 250usec. The physician believed that the patient would have an anxiety attack that could trigger seizures if the patient felt stimulation from the device. With the adjustment to the device pulse width, the patient no longer felt stimulation and did not have another event since the adjustment. The patient¿s seizures have improved past pre-vns baseline levels.

Event Description
On 03/18/2015 it was reported that the patient¿s device was turned off on (b)(6) 2015. He was having ¿panic attacks¿ that would lead to seizures. The physician believes that the panic attacks may be brought on from the stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4131946
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dennis100
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« Reply #67 on: November 13, 2017, 02:34:13 AM »

Model Number 102
Event Date 12/08/2014
Event Type Injury
Manufacturer Narrative

Event Description
Analysis of the returned generator was completed. Monitoring of the device output signal 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. The generator performed according to functional specifications. There were no anomalies found with the pulse generator.

Event Description
The explanted generator was returned to the manufacturer where analysis is currently underway.

Event Description
Handwritten clinic notes were received which were mostly illegible. The notes included assessments of the severity of the patient¿s symptoms on a 1-10 scale. On (b)(6) 2014, the patient¿s mood was classified as level 5 and the patient¿s anxiety and insomnia were classified as level 4. It was noted that the patient presented manic symptoms. The patient had been doing worse with the prescribed medications so the medications were adjusted. On (b)(6) 2014, the patient¿s symptoms were noted to be slightly improved and stable. The patient¿s mood, anxiety, and insomnia were all classified as level 3. The physician indicated that the patient¿s device had been or will be checked. On (b)(6) 2015, the patient¿s mood and insomnia were noted to have worsened and were classified as level 6. The patient¿s anxiety was listed as stable and classified as level 3. The patient presented with manic and general anxiety symptoms. The patient¿s medications were adjusted during this office visit. On (b)(6) 2015, the patient¿s mood and anxiety were classified as level 4 and the patient¿s insomnia were classified as level 3. The patient also complained of a new issue classified as level 5, which could not be determined due to the illegible handwriting of the notes. The patient presented with depressive and general anxiety symptoms. On (b)(6) 2015, the patient¿s mood was noted to be up and down and was classified as level 3. The patient¿s anxiety and insomnia were classified as level 3 and noted to be stable. The patient showed moderate improvement in her condition. There is no indication in the notes that the patient¿s symptoms were related to vns.

Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2015. The explanted generator has not been returned to date.

Event Description
Additional information was received stating that the vns patient was referred for surgery due to battery depletion. No known surgical interventions have occurred to date.

Event Description
Additional information was received stating that the vns patient was unable to perceive stimulation on-times from her device. Attempts for additional relevant information have been unsuccessful to date.

Event Description
It was reported that the vns patient¿s device was not working properly. The patient stated that she had good results with vns but recently began experiencing severe changes in her mood. The patient¿s physician was making plans to resolve the issue but no details were provided. Attempts for additional relevant information will be made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4391182
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dennis100
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« Reply #68 on: November 14, 2017, 02:07:56 AM »

Event Date 02/01/2015
Event Type Malfunction
Event Description
Additional information was received that the patient was referred for explant surgery. Clinic notes were received stating that the patient attended a surgical consult with the chief complaint of wanting the vns system removed. It was stated that the patient is concerned that an anti-theft system on his new car caused the stimulator to be turned back on after having been disabled for approximately the past 7 years. The patient reportedly has not had his vns interrogated since purchasing the new car. No known surgical interventions have occurred to date.

Manufacturer Narrative

Event Description
It was reported that the vns patient¿s had been disabled seven years ago due to anxiety. However, the patient believes electric hair clippers or the car door opener had programmed the device back on. 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=4549218
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dennis100
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« Reply #69 on: November 16, 2017, 02:27:50 AM »

Model Number 102
Event Date 02/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received dated 02/03/2015 which indicate the patient is feeling more depressed and anxious since her last visit. Lately she hasn't noticed the vns much for the past year and she is getting more depressed. The patient was referred for a generator replacement, although surgery is likely it has not occurred to date. Good faith attempts for further information from the physician were made but no additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4573558
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dennis100
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« Reply #70 on: November 27, 2017, 02:54:14 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 07/13/2015
Event Type Injury
Manufacturer Narrative
The udi number was inadvertently left off of the initial mfr. Report. (b)(4).

Event Description
It was reported that the patient visited the er as she was experiencing an altered perception of stimulation as it was stated she could feel it, go off, every 30 seconds; however, the patient claimed the neurologist had set the device to go off every 3 minutes. It was also noted that this stimulation was painful. During this visit to the er, she was given ativan for her anxiety. The patient visited the er the following day with the same complaints. She also stated the ativan was not helping; however, later she states that she felt much better after her shot of ativan. The patient then stated that she does not usually have an aura, but she now has a sense of smell and burnt toast almost all the time recently. It was also reported that the patient has some discomfort earlier in her chest radiating to the left shoulder. There was no additional information on the chest pain other than it was not related to exertion or breathing. The patient's pain was treated with dilaudid. It was noted that the patient's device has been checked several times since it was implanted in (b)(6) of 2014 and there have been no issues. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description
It was later reported by the physician that he does not believe the patient's reported pain is related to vns. It was also reported that system diagnostics were normal and the impedance value was normal. It was noted this patient has a number of psychological issues. No other additional relevant information has been reported to date.

Manufacturer Narrative
Results; this information was inadvertently left off of the supplemental #02 mfr. Report.

Event Description
It was reported by the patient's following physician that the er physician had said the patient's smell of burnt toast was not related to seizures. However, it was noted by the patient's following physician that this was new to the patient after the patient was seen and assessed on (b)(6) 2015. Additionally, the physician explained that the patient has a history of anxiety issues which is the cause of the patient's complaint of the vns device firing too often. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5005006
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dennis100
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« Reply #71 on: December 15, 2017, 01:58:43 AM »

Model Number 106
Event Date 02/24/2016
Event Type Injury
Event Description
Follow up indicated that patient have sleep fragmentation, sleep apnea, day time sleepiness, impairment of pre-existing depression/ anxiety, impairment (or at least: lack of improvement) in seizure frequency. The physician changes the patient's settings two times a day as the patient is in the emu. When the patient goes home he will be set to the highest setting that does not cause sleep disturbance at night (reduction in output current from 1,125 to 1ma at daytime and 0,5 ma at nighttime. Reduction of the output current of the magnet stimulation and autostimulation from 1,125 to 0,75 ma). Further information about the patient and the implanted devices has been provided. The review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

Manufacturer Narrative

Event Description
It was reported that a vns patient has the autostimulation triggered by arousals (sleep disturbances). This was confirmed by a polysomnography. Reducing the output current from 1ma to 0. 5ma solved the problem and the patient sleeps well. No additional information has been provided.

Manufacturer Narrative
Udi-no. : (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5619205
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dennis100
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« Reply #72 on: January 19, 2018, 02:55:01 AM »

Model Number 102
Event Date 01/01/2010
Event Type Death
Event Description
It was reported by the physician that the patient had died on (b) (6) 2010. The patient continued to have daily seizure. Patient was taken to the hospital and confirmed dead a few hours later. Autopsy determined to be a definite sudep. Autopsy report or death certificate was not available to manufacturer. It was stated by the physician that the relationship between vns and cause of death unknown. Device was not explanted and therefore not available for analysis. Follow up with the physician revealed that patient's seizures were never improved by medication or vns. All those seizures were not related to epilepsy. Some of them were pseudo seizures due to a very high level of anxiety. Patient suffered from psychiatric problems linked to her very complicated and difficult youth. The cause of death is unknown at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1627893
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« Reply #73 on: January 28, 2018, 02:03:13 AM »

Model Number 103
Event Date 08/27/2010
Event Type Injury
Event Description
It was initially reported that the recently implanted pt pvc that occurred about once per month. The pt has a cardiac diagnosis of perimembranous ventricular septal defect, small and restrictive with infrequent pvcs, the pt is not on any cardiac medication and was last seen by a cardiologist on (b)(6)2009. The pt was implanted the week prior to the report. The pt is said to be having pvcs "a little more frequent" over the three days since implant, but was not daily or with stimulation on-time. The pt also has depression and anxiety. The nurse practitioner has recommended a holter monitor for 72-hrs. If there were no issues seen, the pt would continue the monitor for 30-days. The site wanted to confirm there was an increase in pvcs and the relationship to the therapy/surgery or other external issues/stressors. The nurse was unable to rule out the device as a contributory factor at this time. No diagnostics were immediately available of the pt's device. Info received from the company representative present during the implant surgery indicated that the anesthesiologist noted some "cardiac changes" during administering the anesthesia prior to the start of surgery. These issues were said to have resolved after the pt fell asleep. The anesthesiologist felt it was anxiety related at that time since she was awake. Diagnostics performed on the device during surgery were said to be within normal limits, and there were no cardiac issues noted when the pt was turned to 0. 25ma. The nurse later reported that the family refuses to disable the device so the pt will have a holter monitor at this time. Since the pt is known to have a lot of anxiety, the decision may be to be slower titrations of her therapy. No further details have been received on the issue. Good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1858494
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« Reply #74 on: February 28, 2018, 02:13:39 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 03/27/2017
Event Type Injury
Event Description
A patient called and reported that she went to the emergency room due to an arrhythmia and a panic attack. The patient stated that her vns device was "going crazy" while she was in the hospital, meaning it was stimulating a lot. Attempts to obtain additional information were made to the physician, but no relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6508647
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« Reply #75 on: April 07, 2018, 01:02:23 AM »

Model Number 103
Event Date 12/14/2012
Event Type  Injury   
Event Description
Additional information was received that the physician feels that the patient's increase in seizures were due to her disease progression. Patient was reported at a (b)(6) 2013 appointment to be having 7-8 seizures a week.
 
Manufacturer Narrative

Event Description
It was initially reported that the patient had uncontrolled seizures. The patient had multiple seizures and was admitted to the hospital. Her lamictal level was low and the dose was increased as a result. The patient also had additional seizures believed to be due to the generator being at end of service but that was later determined that the generator was not at end of service. The patient was given 10 mg of valium and did not have a recurrence of the seizures. It is unknown if the seizures were above or below pre-vns baseline or the relationship to vns. The physician believed some of the reported seizures were actually pseudo-seizures and the patient has underlying anxiety which contributed to them. The patient was started on a medication that she had responded to well in the past. The patient also have a setting adjustment increased (output current - 3. 25 ma, pulse width - 500 usec, on time - 30 sec, off time 3 minutes) which the patient tolerated well. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2941915
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« Reply #76 on: April 14, 2018, 12:52:12 AM »

Model Number 103
Event Date 01/28/2013
Event Type  Injury   
Event Description
A vns patient's mother called and reported that about 2 weeks ago, after their last clinic visit when her settings were adjusted, she states that her daughter started having increase in her seizure frequency that was above baseline. She says that her daughter only had 1-2 seizures/week before the vns and she had a least 7 seizures in a week around 2 weeks ago. She said that their doctor had increased her settings again last week when she went back and the patient has not had anymore seizures since then. It was also reported that they had an office visit last week to check the device and they were not able to detect the magnet swipes. She reported that she routinely swipes the patient's magnet every day to make sure it is working. It is unknown if the date and time was correct on the handheld. This can affect the display. She states that her daughter does not have a response when she does that but when she swipes it during a seizure she becomes panicked and almost combative at that time. Patient settings are not known at this time. Good faith attempts were made with their following physician and no further information has been attained.
 
Manufacturer Narrative

Manufacturer Narrative

Event Description
No further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2990011
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« Reply #77 on: April 16, 2018, 01:18:01 AM »

Model Number 103
Device Problem No Information
Event Date 10/05/2012
Event Type  Death   
Event Description
Cause of death information obtained from the (b)(4) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2012 and the patient's cause of death was cardiomegaly which was contributed by unspecified anxiety disorder and other, unspecified convulsions. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
A vns treating physician reported that one of his patient passed away. No further information has been received from the patient's treating physician. It was reported in their obituary that they died peacefully in their sleep. It is unknown if the patient passed from sudep and at this time given all the information available a probable sudep. Good faith attempts are underway for further information surrounding this patient's cause of death.
 
Manufacturer Narrative

Event Description
Good faith attempts have been made and no further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3075128
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« Reply #78 on: May 14, 2018, 02:42:28 AM »

Model Number 106
Device Problem No Information
Event Date 10/16/2013
Event Type  Malfunction   
Manufacturer Narrative
This information was inadvertently left off of supplemental mfr. Report #01.
 
Event Description
It was reported that the patient¿s seizure history has not changed as of (b)(6) 2013 and varies from month to month. The patient has an extreme amount of seizures historically. The patient complaint was that the vns had not helped with her seizure activity as well as they had hoped for, but did state it had decreased the duration of the seizures. The physician reportedly has not indicated that the patient¿s seizure pattern/occurrence is a profound worsening and should be considered an adverse event. The vns normal mode current was decreased to 1. 0ma from 1. 75ma, and the painful stimulation resolved totally during post adjustment period in the office. The increased current on (b)(6) 2013 was a contributor to the pain with no other know contributing factors.
 
Manufacturer Narrative

Manufacturer Narrative
The information reported on the supplemental report #3 was not in relation to the events in this report #. The information was relevant and reported accurately in mfr report #: 1644487-2014-00695. If remedial action initiated, corrected data: the information reported on the supplemental report #3 was not in relation to the events in this report #. The information was relevant and reported accurately in mfr report #: 1644487-2014-00695. No remedial action was taken in relation to the events captured in this mfr report #. Action reported to fda under 21 usc 360i(f), list correction/removal reporting number, corrected data: the information reported on the supplemental report #3 was not in relation to the events in this report #. The information was relevant and reported accurately in mfr report #: 1644487-2014-00695. No actions are taken in relation to the events captured in this mfr report #.
 
Event Description
The information reported on the supplemental report #3 was not in relation to the events in this report #. The information was relevant and reported accurately in mfr report #: 1644487-2014-00695.
 
Event Description
Further manufacturer investigation was completed. Based on the information gathered through the investigation, the root cause was determined to be an unintended design issue, which allows the burst watchdog timeout event to occur when all of the following conditions are met: 1. Sensing is enabled and autostim burst is in progress. 2. Magnet output current = autostim output current. 3. Autostim output current = 0. 25ma and frequency = 10hz (i. E. Ramp enabled). 4. Magnet is repeatedly applied (i. E. Reed switch closed) for >300ms and = 3 seconds. The issue is caused by the method by which the device firmware calculates the remaining time in autostim on time after a magnet activation occurs when conditions 1 through 3 above are present. When recalculating the stimulation burst time following a magnet activation, an additional two seconds is added to the time to account for ramp up. If the magnet is repeatedly swiped at a pace with less than two seconds between magnet activations, multiple recalculations can add enough time to allow the stimulation to exceed the watchdog timer.
 
Event Description
Patient¿s husband reported an increase in seizures after vns implantation. Patient is implanted with a model 106 generator, currently under (b)(4) undergoing clinical study evaluation. The model 106 device delivers stimulation in the same manner as other commercially distributed devices, and is therefore considered similar to those devices for the purposes of this event. Seizure activity in (b)(6) was noted to be higher than during other months since implantation. Patient¿s record of seizures (from husband¿s record) during month of october includes: (b)(6) ¿ 7: 18 seizures; (b)(6) ¿ 12: 56 seizures; (b)(6) ¿ 16: 13 seizures; (b)(6) ¿ 21: 5-12 seizures/night each night; (b)(6) ¿ 28: 35 seizures. From (b)(6), the patient was not receiving vns stimulation. Output current was at 0 ma during this time. According to physician, patient has had seizure control with intermittent seizures, but experienced marked increase in nightly seizures approximately 1 year prior to vns implant. Physician has indicated that patient has cyclical seizure pattern, and that while the total seizures may be more than pre-vns state, they are not dissimilar to prior exacerbations. Physician indicates that increased seizures could have been a possible secondary effect of painful stimulation reported by the patient due to intensity of stimulation resulting in increased anxiety and insomnia. Physician has since lowered settings to resolve painful stimulation; patient's seizure frequency, intensity, and duration have all reportedly decreased within the last month.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3520124
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« Reply #79 on: May 28, 2018, 01:37:36 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 09/04/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that this patient was in the er complaining of continual shocking in her neck from the vns, the patient's device¿s output current was lowered, and diagnostics tests were performed and were within normal limits. The patient was noted to be seizure and medication free where she was previously on 9 medications. The patient had a fall recently, and the pain was said to originate in the generator site and radiates into the neck, jaw and face area. The pain felt continuous in the chest and neck areas. During the appointment with the nurse, it was observed that the patient had an irregular/fast heart rate that was concerning to the nurse. The patient¿s device was disabled and the pain subsided along with the heart rate issues. The patient was said to still be sore despite no stimulation. An ekg was taken, and was said to be normal, and the patient may be referred for revision due to the issue. The nurse was concerned there was a device malfunction due to the recent events, but diagnostics were within normal limits. Additional information was received that the patient previously was having 10 seizures a day before vns, and was on 9 medications, and after vns she had been completely seizure free. The device was disabled by her nurse practitioner, and the patient had 4 seizures that following night. The patient therefore went back to the er where the doctor was skeptical if they were actual seizures or not, as the patient is in a perpetual state of hysteria. Due to the patient¿s reported seizures, the device was programmed back on. Additional information was received from the patient's provider. They mentioned that the patient feels stimulation all the time, but the device is only going off every 5 minutes, so the doctor is not sure what the patient is feeling. The magnet was used at night during one of the patient's seizures, and the patient woke up in pain. The provider doesn't know if the pain is real or what exactly is going on. The doctor thinks the patient could possibly be getting down to the end of her battery life, even though she recognized it was okay according to system diagnostics. The neurologist from their clinic believes the patient is having pseudo-seizures, because the patient is very anxious. The patient mentioned being very light headed and dizzy and almost passed out before seeing the nurse practitioner (np) at the clinic. The patient was said to have sinus arrhythmia prior to having the vns implanted. The nurse was able to hear some heart irregularities that she couldn't identify when the vns was on. When the vns was disabled, and they were monitoring the patient, it was noted that no cardiac issues came up; therefore the nurse believes that the vns may have exacerbated some of the patient's heart issues. The patient's heart rate rose to about 110bpm at one point, but the nurse believes this to be from the patient's anxiety and previous heart condition. The nurse mentioned she did not know where the pain is coming from, or why, because the device looks okay, according to diagnostics. The nurse also mentioned that she palpated the patient's chest and neck, and the patient did not have any pain or soreness. Diagnostics were run when the patient was in many different positions and all diagnostics were within normal limits. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6942048
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« Reply #80 on: September 08, 2018, 12:40:02 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/30/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was stated that a patient was experiencing sinus tachycardia about 4 hours post-vns surgery. The patient was in good health and reported this to be a new event for them. It was stated that the surgery had gone well, including ok diagnostics and impedances. An update was received stating the patient was discharged from the hospital two days afterwards with normal heart rate and no other issues. Follow up indicated that the tachycardia was stated to not have occurred with stimulation as the device was not turned on post-operation. The physician believed that the tachycardia, unrelated to vns surgery, was related to the patient anxiety that occurred post-operatively from surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7811075
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« Reply #81 on: October 16, 2018, 03:08:56 PM »

Model Number 102
Event Date 04/01/2012
Event Type  Injury   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
The patient's explanted generator and lead were retuned on (b)(6) 2012. A 'return product form' indicated that the device were explanted due to prophylactic replacement and because the patient did not feel magnet mode stimulation consistently, along with increasing symptoms. Evaluation of the explanted pulse generator's reed switch was performed on the test bench, which confirmed normal, expected reed switch function and magnet current with magnet activation. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Follow-up on (b)(6) 2012, showed that the lead was explanted due to a lead discontinuity. Diagnostics from (b)(6) 2012, were also provided. This lead event, along with product analysis results for the explanted lead, is captured in mfr. Report #1644487-2012-02507. Additional follow-up with the initial reporter showed that the patient's events had not resolved since revision. The patient still had the feeling that she was going to have a seizure daily; however, the patient would also feel anxious during these events, so it was difficult to say what the patient was actually experiencing. The patient could also not feel magnet mode stimulation. This was attributed to the patient's current settings being lower than pre-revision settings. The patient was slowly being ramped up. The patient's pre-operative settings and settings from her most recent appointment ((b)(6) 2012) were provided.
 
Event Description
On (b)(6) 2012, a nurse reported that this vns patient could not feel magnet mode stimulation. The patient did report an inability to perceive normal mode stimulation. The nurse also reported that the patient complained of feeling "seizurey. " this was clarified to mean an increase in seizures. The patient's diagnostics were provided (date unknown). The patient's settings from (b)(6) 2011, (b)(6) 2012, and earlier were provided. A battery life calculation was performed on (b)(6) 2012, with 1. 6 years remaining until eri = yes. On (b)(6) 2012, the patient's nurse provided the following information. The increase in seizures was first observed in (b)(6) 2012. The patient was brought into the hospital for a possible seizure, associated with volume depletion/dehydration. The patient's constant feeling of being "seizurey" started within the past month. The nurse stated that it is unclear if these are prodromal symptoms and/or partial seizures. The symptoms consist of room spinning, numbness left side of head, confusion, and being scared. The patient has a history of mesial temporal sclerosis by mri and generalized activity on eeg. The nurse was unable to get an accurate count of the events. The nurse stated that while diagnostic testing is within normal limits, she presumed that the change in stimulation sensation and increased events are likely related to battery reaching end of service. As intervention, the patient's pulsewidth was decreased on (b)(6) 2012, and the patient's keppra dose was increased on (b)(6) 2012. Prophylactic replacement of generator was also being planned. No information was provided regarding the comparison to pre-vns seizure levels. In response to causal/contributory programming changes or events occurring prior to the increase in seizures, the nurse stated that the patient was admitted to the hospital in (b)(6) 2012, for dizziness followed by loss of consciousness. There was no clear cause, but the patient was hyponatremic, had a subsequent confusion episode and a possible seizure associated with dehydration. Within past month, there have been other possible lifestyle triggers but these were not new. The failure to perceive magnet mode stimulation was first observed within the past month. The patient reportedly uses the magnet frequently and reports being unable to feel magnet stimulation in past month. Previously, she had been able to feel it. No patient manipulation or trauma occurred that is believed to have caused/contributed to the stimulation not perceived. The patient's magnet mode diagnostics were not run. On (b)(6) 2012, the patient underwent surgery. Attempts for product return have been unsuccessful. An additional battery life calculation was performed on (b)(6) 2012, with updated data. The results indicated 1. 69 years to eri=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2702307
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« Reply #82 on: January 20, 2019, 03:03:25 AM »

Model Number 302-20
Event Date 05/13/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient was referred for surgery to explant his device due to discomfort and pain from a lead pulling sensation whenever he turned his head. The patient¿s device was disabled in 2011 due to lack of efficacy in treating the patient¿s depression. It was later determined that the patient did not have depression but was suffering from an anxiety disorder. The patient¿s generator and lead were explanted on (b)(6) 2014. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Additional information was received stating that the vns patient underwent surgery for patient comfort and not to preclude a serious injury. The patient was a non-responder to vns therapy; therefore, the patient¿s generator was explanted and not replaced. Analysis of the returned generator and lead was completed. Monitoring of the generator output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the setscrew marks observed near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. The connector pin was inserted into the cavity of a test generator to verify a dimensional issue in the connector portion of the lead wasn¿t preventing the connector pin from being fully inserted into a generator. No obstructions were noted. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Canted spring marks were not observed on the rear end of the small o-ring. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3854239
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« Reply #83 on: January 22, 2019, 06:11:47 AM »

Brain Stimul. 2008 Apr;1(2):112-21. doi: 10.1016/j.brs.2008.02.001. Epub 2008 Mar 28.

A pilot study of vagus nerve stimulation (VNS) for treatment-resistant anxiety disorders.

George MS1, Ward HE Jr, Ninan PT, Pollack M, Nahas Z, Anderson B, Kose S, Howland RH, Goodman WK, Ballenger JC.

Author information

Abstract

BACKGROUND:
Vagus nerve stimulation (VNS) is an effective anticonvulsant device and has shown antidepressant effects in chronic treatment resistant depression. Because the vagus nerve sends information to brain regions important in anxiety regulation (locus coeruleus, orbitofrontal cortex, insula, hippocampus and amygdala), this pathway might be involved in perceiving or manifesting various somatic and cognitive symptoms that characterize anxiety disorders. On the basis of this reasoning and reports of anxiolytic effects of VNS in patients treated for epilepsy and depression, we organized an open-label pilot acute trial of adjunctive VNS on top of stable medications, followed by long-term follow-up, to assess the safety and potential efficacy of VNS for patients with treatment resistant anxiety disorders.

METHODS:
Eleven adult outpatients with treatment resistant obsessive-compulsive disorder (OCD), panic disorder (PD), or posttraumatic stress disorder (PTSD) were recruited. Patients had failed several medication trials as well as cognitive behavioral therapy (CBT). All patients were rated with the Hamilton Anxiety Scale (HAM-A) and the clinical global impressions improvement scale (CGI-I). Patients with OCD were also rated with the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). Patients were maintained on their current psychotropic medications at fixed doses during the acute 12-week phase. Changes in medications and VNS stimulus parameters were allowed during the long-term follow-up. Response was defined as a 50% or greater improvement on the HAM-A for all patients and a 25% or greater improvement on the Y-BOCS for patients with OCD.

RESULTS:
Eleven patients were recruited. Seven patients had a primary diagnosis of OCD, two had PTSD, and one had PD. One OCD patient changed their mind and was never implanted. One patient with OCD withdrew consent before the end of the acute phase, so long-term results were available for nine patients. Three patients were acute responders, based on the HAM-A, and there was some improvement in anxiety ratings over time (with statistically significant improvements at 14 of 18 quarters during long-term follow-up). Of the seven patients with OCD who received stimulation, three were acute responders, based on the Y-BOCS, and there was some improvement in Y-BOCS scores over time (with statistically significant improvements at 7 of 18 quarters during long-term follow-up). VNS was relatively well tolerated. Four years after implantation, four patients (diagnoses two OCD, one PD, one PTSD) were still receiving VNS with continued and sustained improvement in anxiety scores compared with their baseline scores.

CONCLUSIONS:
These patients with treatment-resistant anxiety disorders generally tolerated VNS treatment, and there was evidence of acute and long-term improvement in some patients. These open data suggest that further double-blind studies assessing the VNS role in treating anxiety disorders, particularly OCD, may be warranted.

PMID: 20633378 DOI: 10.1016/j.brs.2008.02.001

[Indexed for MEDLINE]

https://www.ncbi.nlm.nih.gov/pubmed/20633378
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« Reply #84 on: February 28, 2019, 03:21:50 AM »

Model Number 102
Event Date 04/23/2015
Event Type  Injury 
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that both the generator and the lead passed all functional tests prior to distribution.

Event Description
It was reported that the vns patient had presented increased seizures for 6 weeks. It was reported that the patient had benefited from vns therapy when the duty cycle was increased from 16% to 29%. Night seizures had not occurred since (b)(6) 2015 after the increase in the duty cycle. The night seizures occurred again six weeks earlier and the patient also presented complex partial seizures during the day, after waking up, with anxiety, rapid heartbeat, panting, stiffening of the arms and partial loss of conscience, being able to hear but not to respond. It was also reported that the vns generator was interrogated and the output current was found at 1ma while it had been programmed at 2ma in the last follow up visit, with the rest of the settings unchanged: frequency 25 hz, pulse width 500usec, 21sec on time, 1. 1min off-time, magnet output current 2. 25ma. The patient¿s device was tested and system diagnostics returned impedance results within normal limits with dcdc 2 and normal mode diagnostics returned dcdc 5. It was reported that the impedance results were the same as in (b)(6) 2015. It was reported that the output current was set to 2ma and the duty cycle was increased from 29% to 36% with 21sec on-time and 0. 8min off-time. The patient had not noticed when vns stimulation did not alter the voice any longer. The patient is (b)(6) years old and has had epilepsy since her (b)(6) year. During the first year she had several seizures per year over a period of 3-4 weeks with anxiety seizures and milder seizures with rapid onset of abdominal pain with paleness without loss of consciousness and generalized tonic-clonic seizures. From her (b)(6) year she presented mainly 3 night seizures per week w, no longer in clusters. The epilepsy is mri negative, with both temporal as frontal symptoms. Review of the available programming and diagnostic history showed normal diagnostic results and no programming anomalies through (b)(6) 2015. Review of manufacturing records confirmed that the generator and the lead passed all functional tests prior to distribution. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4874298
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« Reply #85 on: April 06, 2019, 02:01:40 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/22/2019
Event Type  Injury   
Event Description
It was initially reported that the patient was unable to feel stimulation, and that the patient and her spouse suspected the device¿s battery was dead. Additional information was reported that the patient also experienced an increase in seizures which were more intense and required the patient to be taken to the hospital. Given the significant length of device implant (>12 years), the estimation of the patient's remaining vns battery life, and the clinical symptoms the patient exhibited it was suspected that the vns battery was depleted. However, it was later reported by the patient that a neurologist had checked her device and found that the battery life was above 25% and that the magnet stimulation was increased by 75%. Per the patient, she was told by her nurse practitioner that anxiety resulted in her being unable to feel stimulation and having more frequent and intense seizures; however, the patient disputed that she was experiencing anxiety. The patient was referred for replacement reportedly due to the length of the device¿s implant. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8384095
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« Reply #86 on: April 10, 2019, 01:30:26 AM »

Model Number 102
Event Date 05/01/2016
Event Type  Malfunction   
Event Description
It was reported that the patient started experiencing pain at the generator site recently. The pain was not reported to be associated with stimulation. The pain is however causing the patient to have panic attacks which lead to increased seizures. Patient was provided a neurologist contact information and asked to follow up with the physician regarding the concerns. However, no additional relevant information was received.
 
Event Description
Additional information was received that the patient is still having pain in his arms/legs and generator site, but this pain is present even when the device is "off. " patient has held the magnet up to his generator for 5 minutes at a time t temporarily disable stimulation, and experiences worse pain during the disablement. The pain often wakes him from sleep and he wakes up in a sweat. Patient said that a doctor has mentioned that this could be related to anxiety, but it has not been confirmed. Additional information was received that the patient's vns settings were programmed at unusual setting of 30 seconds on time and 150 minute off time. The reason patient was feeling pain during the stimulation was because the settings were too high and there was a long break in between. The physician adjusted the patient's settings to a normal duty cycle and reduced the output current but the settings and diagnostics were not provided. Seizure patterns will be evaluated on an ongoing basis now that the vns has been programmed appropriately.
 
Event Description
Patient underwent explant surgery due to shoulder and neck pain. The physician stated that the patient demanded it be removed due to shoulder and neck pain. A portion of the lead was cut but the electrodes remain implanted. No other relevant information was received.
 
Event Description
Follow-up was later received that the patient will have the remaining portion of the lead removed. The additional surgery is not known to have occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5704559
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« Reply #87 on: April 16, 2019, 01:05:57 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/11/2016
Event Type  Injury   
Event Description
It was reported by the physician, through clinic notes, the patient has had an increase in seizures, along with a jerkiness and aura that the magnet does not always stop. The physician stated the device was nearing end of service and a new generator would be helpful. The physician noted the device diagnostics were within normal limits on (b)(6) 2016. A blc was performed showing the vns had approximately 9. 5 years remaining. However, it should be noted that the last information came from 09/26/2012 and the patient was only at a 9. 3% duty cycle. If the patient's settings had been increased between 2012 and now, it could greatly change the battery life calculation. Attempts for additional relevant information have been unsuccessful to date. No known surgeries have occurred to date.
 
Event Description
An implant card was received which showed the patient had a generator replacement on (b)(6) 2016. It is unknown whether or not the device was discarded after surgery. The generator replacement was noted to be prophylactic, although it was also marked at neos = yes (near end of service). The neos = yes condition would still be delivering the intended amount of therapy and it was confirmed that the impedance value was within normal limits and not malfunction was suspected with the device. Additionally, it was reported by the patient's physician that the patient was not actually having an increase in seizures, but she was having anxiety symptoms of twitching and stuttering. There was no indication the anxiety was related to vns. The physician stated that once she treated the patient's anxiety, the symptoms stopped.
 
Event Description
Additional clinic notes were received after the patient's replacement surgery had already occurred. The clinic notes were from before the patient's surgery. These notes mentioned the patient's generator was at ifi = yes on (b)(6) 2016 and it was noted the patient would need her battery changed in the near future. It was further explained in the clinic notes that the patient was losing her voice. This was mentioned along side the report of stuttering. The physician noted she lowered the vns settings, but this did not help the patient's voice issues. It was noted that the settings were increased again within the same visit (back to the patient's therapeutic levels) and the patient left the office at her normal settings. These notes provided additional information as it appears the speaking issues were also related to the patient's anxiety. It was reported in the supplemental #01 mfr. Report that the patient's anxiety was treated and the symptoms of stuttering and twitching stopped. The notes were simply received out of order, but provided additional information regarding the patient's anxiety symptoms, which were not related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5966294
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