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dennis100
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« Reply #270 on: January 18, 2018, 02:29:42 AM »

Model Number 303-20
Event Date 04/01/2012
Event Type Malfunction
Event Description
Additional information was received on (b)(6) 2012. The patient is continuing to complain of pain in her chest (center) and pain up the side of her left neck. Patient is also not feeling magnet stimulation. Diagnostics were run twice 4065ohms and 4350ohm. The magnet current was increased to 2. 0ma and regular current to 1. 75ma and diagnostics were re-run with impedance 4306ohms and low output current. At these settings the patient began feeling nauseous however this was thought to be related to her headache. It was indicated that the patient had not had a big increase in her seizures. The physician was uncertain if the increase in seizures or depression were associated with vns, however he did indicate that he believed that the pain she was experiencing was related to the irregular impedance values. The myocardial infarction was also not believed to be related to vns. Per the physician, the patient's pain varies so he was uncertain if it was occurring with stimulation, however it was indicated that the device was left programmed on as the patient did not want the device disabled. She has again been referred for revision. It was also noted that there were no causal or contributory programming changes, medication changes, or other external factors precede the onset of the events. Additionally the patient was not experiencing voice alterations, per the physician. Revision is likely but has yet to occur.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was reported on (b)(6) 2012, that a system diagnostic test performed that day at a patient's follow up appointment revealed high impedance, with an impedance value of 8591 ohms. The patient also reported an increase in seizures the past 8 weeks, and also feels uncomfortable in her neck and chest (generator and electrode sites) when she turns her head to the right. It was unclear if the pain was occurring with stimulation. They were not aware of any manipulation or trauma. X-rays were performed and sent to the manufacturer for review. A/p and lateral views of the neck and chest of the vns patient were received and reviewed on (b)(4) 2012. The generator was seen in the left chest. The placement was normal, and the filter feedthrough wires appeared to be intact. The connector pin could be visualized past the second connector block indicating that the pin was fully inserted. A portion of the lead appears to be behind the generator, so continuity in that portion of the lead could not be fully assessed. The lead was routed upwards to the left side of the neck. There appeared to be a suspect area near the generator; however, this could not be fully assessed due to the contrast in the images provided. The lead wire also appeared twisted and kinked in the chest near the neck. No lead discontinuities or sharp angles were seen in the visible portions of the lead; however, it is possible a lead break has occurred in the suspect area near the generator. Additionally a micro-fracture that cannot be seen in the images provided, or a break in the portion of the lead which could not be assessed cannot be ruled out. Clinic notes were also received indicating that the patient had a myocardial infarction that occurred on (b)(6) 2012, and spent two weeks in the hospital for the myocardial infarction and pneumonia. The patient has also had an increase in depression. The relationship between the patient's depression and myocardial infarction and vns therapy is currently unknown. Additionally, the surgeon reported performing diagnostics on (b)(6) 2012, and was questioning the reason for the replacement, as he checked the device on (b)(6) 2012, and the diagnostics showed everything to be ok, with an impedance value in the lower 6000 range. The diagnostics were run 3 times, with the same results. The neurologist also reported performing diagnostics with results in the 5800-6300 ohm range. At this time, the surgeon is hesitant about performing a full revision he indicated that the patient is very large and he is concerned about performing surgery. It is likely that a positional lead break has occurred, which is causing the intermittent impedance issues. No additional information is known at this time.

Event Description
Information was received on 07/27/212 indicating that the surgeon also reviewed the x-rays and did not feel that there as an issue despite identifying the kink in the lead. Additionally he reported that the neurologist would be increasing the patient's output current to determine if that helped. The patient had also previously reported experiencing voice alterations with stimulation as well as that she was unable to perceive magnet mode stimulation. The surgeon had re-instructed that patient on how to perform magnet swipes as he felt that it may have been related to improper swiping technique. Attempts for additional information have been unsuccessful to date.

Event Description
Additional information was received on (b)(6) 2012, that the patient had a full revision. Attempts for product return are underway.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
The patient had previously reported voice alterations and failure to perceive magnet stimulation, however this was not included on the initial mdr.

Event Description
The explanted lead and generator were returned to the manufacturer on (b)(4) 2012. Analysis has since been completed. During analysis of the lead, a break was identified in the positive coil. Scanning electron microscopy images of the positive coil ends show that pitting or electro-etching conditions have occurred at the break location and in the vicinity of one of the broken ends. Inspection of the positive lead coil indicates a stress-induced fracture has occurred in at least one of the broken strands of the coil. However, due to metal dissolution, mechanical distortion (smoothed surfaces) and/or surface contamination, a conclusive determination of the initial fracture mechanism of the broken strands cannot be determined. The silicone tubing is abraded open near the identified break. Additionally, the lead assembly has remnants of what appears to be dry body fluids inside the silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portions. Analysis on the generator revealed no anomalies. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Additionally, it was reported by the surgeon, that following the revision, the patient developed vocal cord paralysis. This will be reported under manufacturer's report # 1644487-2012-02752.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2667369
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dennis100
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« Reply #271 on: January 19, 2018, 02:56:35 AM »

Model Number 102
Event Date 01/01/2009
Event Type Injury
Event Description
It was reported that the pt has not noticed any change in depression since her vns implant (b) (6). Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1637147
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dennis100
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« Reply #272 on: January 22, 2018, 02:10:41 AM »

Model Number 102
Event Date 08/09/2010
Event Type Injury
Event Description
A vns pt reported to the manufacturer that she was experiencing increased depression. The pt also stated that had lost over 150 lbs. In a year and a half time period, but the cause of the weight loss was not mentioned. The pt's physician stated that the pt was in the hospital but did not wish to provide any further info regarding the pt or reason for hospitalization.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1830847
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dennis100
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« Reply #273 on: February 12, 2018, 01:49:07 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 04/01/2016
Event Type Injury
Event Description
It was reported that a patient was experiencing an increase in depression symptoms that began nearly a year prior to the report. The patient's depression was above his pre-vns levels. The device was expected to be functional at the time of the increased depression. No additional relevant information has been provided to date.

Manufacturer Narrative

Event Description
The psychiatrist reported that the patient experienced health challenges, namely, painful leg spasms, that contributed to the patient's increased depression. The leg spasms were not attributed to vns therapy. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6513415
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dennis100
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« Reply #274 on: February 15, 2018, 02:30:33 AM »

Model Number 302-20
Device Problems Corrosion; Fluid leak; Fracture; Mechanical issue
Event Date 10/23/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient was referred for vns generator replacement due to battery depletion. Diagnostics on the form received indicated that the patient's vns was at a near end of service, or neos, = no condition and high impedance was observed with system diagnostics, but not with normal diagnostics. Clinic notes were later received indicating that the patient was experiencing more auras and had become more depressed. The diagnostics provided in the clinic notes indicated the dcdc codes on the previous form received may have been reversed and the system diagnostic were within normal limits. However, the patient underwent full vns replacement surgery and during surgery, high lead impedance was observed. The surgeon found the vns lead to be frayed and the lead separated while being manipulated by the surgeon. It was stated that during testing prior to surgery the dcdc code was within normal limits. The explanted products have not been received by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7105551
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dennis100
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« Reply #275 on: February 15, 2018, 02:31:45 AM »

Model Number 102
Event Date 10/18/2011
Event Type Injury
Event Description
It was reported by the patient's mother that things have gone "downhill" since the patient saw the physician on (b)(6) 2011 to have titration performed. She stated that her son was implanted a couple of months ago and has been set to a very low output current since implant. On (b)(6) 2011, the physician changed the output current to 1 ma (which was a large jump according to the patient's mother). She stated that her son expressed to the physician how much pain he was in and said he didn't want to go that high yet, but the physician told him that she could not turn it down. The patient's mother thinks that the physician might have turned his output current back down to 0. 75 ma or 0. 5 ma but isn't sure. No history is currently available to confirm the patient's settings. Since the visit, the patient has been in intense pain during stimulation. In addition, the mother reported that the patient also has a flutter in his heart and his heart rate changes with the stimulation. Patient has experienced an increase in seizures that is above pre-vns baseline levels and the patient has become very angry since the setting change. The patient's mother went on to say that the patient has become so angry that he has had suicidal thoughts. She clarified that this was only once and that they were monitoring him closely and he seems to not have considered that anymore. The patient had an appointment on (b)(6) 2011 and has reportedly been doing very well since that appointment when the settings were changed. Attempts for further information have been unsuccessful to date.

Manufacturer Narrative

Event Description
Further information received from the physician indicates that at the visit on (b)(6) 2011, the patient had "normal settings" and was at 0. 5 ma. Per physician, the increased seizures were back to pre-vns baseline levels and could be due to a "combination of factors". Patient has intractable epilepsy. The patient had an increase before vns placement and the vns was at low settings. Patient also reports stress and sleep changes which may have contributed to the seizures. Per physician, the patient did not report suicidal thoughts at the last visit, but did report anger and mood changes. The relationship of the level of suicidal thoughts to pre-vns baseline levels is unknown. No known patient manipulation or trauma occurred that is believed to have caused or contributed to the pain. The cognitive changes have multifactorial causes, per physician. The patient is frustrated that the seizures are not controlled and the primary care physician has made medication changes. No known causal or contributory programming changes, medication changes, or other external factors preceded the onset of the events. The patient has been treated for depression in the past by a different physician. The patient's settings were adjusted on (b)(6) 2011 visit and is scheduled for follow-up with physician. The patient was not diagnosed with arrhythmia and no cardiac testing was performed, but the patient reported that his "heart hurt" and felt palpitations. The patient has no history of cardiac issues. Physician does not believe the possible arrhythmia is related to vns, but is unable to rule it out. The event occurred following an increase in depression and seizures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2341562
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dennis100
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« Reply #276 on: February 26, 2018, 02:00:22 AM »

Model Number 102
Event Date 02/01/2012
Event Type Injury
Event Description
It was reported by a nurse that a vns patient experiences vns related asthma. The patient claimed to not have seen her vns physician since 2009 and was warned prior to implant that this could possibly be a side effect from therapy. At the moment, the patient is looking for another physician. Additional information was received from the previous treating nurse indicating the patient suffers from psychological problems. The respiratory problems referred to by the patient have been looked at by a lung specialist and many settings were tried out in order to accommodate the patient, but patient remained unhappy, claiming depression when generator was turned off and asthma when turned on.

Event Description
Moreover, additional information from the treating physician indicated the patient was psychologically unstable prior to vns. After vns was implanted, the patient would have periods of depression which nonetheless were higher than pre-vns baseline.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2467534
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dennis100
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« Reply #277 on: February 26, 2018, 02:01:47 AM »

Model Number 102
Event Date 02/01/2012
Event Type Injury
Manufacturer Narrative
Type of report follow-up #, corrected data: the supplemental report #3 inadvertently reported the follow up #2, but it should have reported it as follow up #3.

Event Description
It was reported that a pt who was implanted with wns in 2008 had a "malfunctioning device" in which the pt's heart rate decelerates during stimulation to around 30 beats per minute. The pt was using the magnet to stop the stimulation. No additional information was provided, and attempts for additional information have been unsuccessful to date.

Event Description
The patient's psychiatrist reported that she recommended that the patient contact a neuroscience department, as the physician is not a vns treating physician. She is not aware of any causal or contributory programming or medication changes that preceded the onset of the patient's arrhythmia. The patient does not have a medical or family history of arrhythmia. The patient pinned the magnet near the generator to keep it turned off. No diagnostics were available, as the physician is not a vns treating physician and does not have a programming system. The details of the patient's bradycardia are reportedly unclear, but the psychiatrist noted that the patient reported that the heart rate dropped to 30 beats per minutes during the event and became dizzy. There were no reported traumatic events prior to arrhythmia. It was unknown if the patient had any triggers prior to the arrhythmia, and it did not occur following a medication change. It is unknown if the arrhythmia was related to vns stimulation, but it did not occur during diagnostics or setting changes, as the psychiatrist does not have a programming system. The psychiatrist attributes the arrhythmia to vns, but notes she is only basing this assessment on the patient's report. It is unknown if vns exacerbated or concurrently contributed to the arrhythmia. No interventions were taken to preclude a serious injury.

Manufacturer Narrative
The initial report inadvertently reported the incorrect event date, as the additional information from the psychiatrist revealed the date to be (b)(6) 2012. The initial report inadvertently reported the incorrect implant date.

Event Description
Additional information was received from the patient reporting that she needs a new dosing psychiatrist. She had been seeing a neurologist as she has had bradycardia issues recently where she had to be hospitalized and he turned off her vns at the end of june to see if that had any effect helping resolve the bradycardia. She reported that she has done well with vns and even came off some medication, but she is anxious to figure out what is going on with her bradycardia because she is concerned her depression will return without vns.

Event Description
A hospital nurse reported on (b)(6) 2012, that the patient was in the hospital and had been experiencing bradycardia the past (b)(6) months, which was occurring with vns stimulation. The patient's normal heart rate is in the mid-high 60 bpm range, and her heart rate has been dropping down in the 20-30 bpm range. The patient's cardiologist recommended to turn the device off as he felt it may be the cause. The patient has seen both her family doctor and cardiologist about this, but the patient has not seen her vns physician as he is on vacation. They were planning on disabling the device. Follow up with the nurse confirmed that the device was disabled on (b)(6) 2012, the patient was discharged with it disabled. The nurse does not know if the device has been turned on again. A vns neurologist was able to come to the hospital and disable the device. The plan was for her to see her normally treating neurologist and psychiatrist to evaluate the next steps. She also reported that she was in the room when the neurologist performed the eeg. She said it was "remarkable" how much her heart rate changed with vns stimulation. When the patient would remove the magnet from the generator site, the rate would go down to the 30's, so the neurologist would instruct the patient to place the magnet over the device again and it would go back to normal again. The heart rate improved once the device was disabled. Attempts for additional information from the neurologist who treated the patient on (b)(6) 2012, the patient's normally treating neurologist, and psychiatrist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2471851
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dennis100
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« Reply #278 on: March 01, 2018, 04:15:40 AM »

Model Number 102
Event Date 01/01/2007
Event Type Injury
Manufacturer Narrative

Event Description
On february 9, 2012 clinic notes from a vns treating psychiatrist were received by the manufacturer. Review of the clinic notes dated november 1, 2011 revealed that the patient has sleep apnea. The psychiatrist later stated that the sleep apnea was first observed in early 2011. He said it is unknown what the relationship of the sleep apnea to vns is. The psychiatrist stated that the sleep apnea probably contributed to the patient's increased depression and suicidal ideations (reported on mfr. Report # 1644487-2012-00597). The sleep apnea is not associated with stimulation. The patient was put on cpap. The psychiatrist stated that it is unknown if any causal or contributory programming or medication changes preceded the onset of the sleep apnea. The psychiatrist then later stated that patient was diagnosed with sleep apnea in 2007 and the vns was implanted in 2006, however ,the psychiatrist stated he was not treating the patient at the time the sleep apnea was diagnosed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2478555
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dennis100
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« Reply #279 on: March 02, 2018, 01:57:33 AM »

Model Number 302-20
Event Date 10/01/2011
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but cannot be confirmed as the device remains implanted in the patient and analysis is not possible at this time.

Event Description
It was initially reported on (b)(6) 2012, that a patient presented high lead impedance on systems diagnostics (7/limit/high/no) during a routine office visit. The patient had some chest pain with stimulation that began a few weeks prior to the office visit. There were no reports of trauma or manipulation. The patient was no longer able to feel stimulation in her neck. The last acceptable diagnostics were (b)(6) 2011, on systems that resulted in ok/ok/2/no and ok/ok/4/no on normal mode. The patient's current settings are 2. 25/30/750/21/3/0/750/60. The patient began to experience an increase in depression since december however it is below baseline levels and the physician believes it is due to the high lead impedance. There were no recent changes in settings, medications, or lifestyle. X-rays were taken and sent to the manufacturer for review. No lead discontinuity was found however there was a portion of the lead is behind the generator and continuity in that portion of the lead cannot be assessed. Clinic notes were received dated (b)(6) 2012, where it was noted that the patient had gradually increasing depression from (b)(6) 2011. Adjustments to the patient's medications were being made at the same time so the patient was not alarmed however the patient began to notice her depression worsening with an increase in manic episodes with rushed thoughts and speech along with a mild spending spree. The patient also had one episode of self-mutilation were she cut her left forearm however there were no current thoughts of self-harm. The self-mutilation is part of the patient's depression as well as the mania. When the depression is worse, these events are more pronounced. The patient does have a history or mania as well as self-harm prior to being implanted with vns. The patient was referred to a surgeon for an appointment on (b)(6) 2012, for evaluation prior to lead replacement. It is unknown when/if revision surgery will occur at this time. In notes dated (b)(6) 2012, it stated that the patient had some mild discomfort in her left chest and no longer had pain in her throat with device stimulation. The chest pain was described as sharp and would increase whenever the physician's assistant pressed on the generator. The device was programmed off on (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2536485
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dennis100
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« Reply #280 on: March 04, 2018, 01:35:16 AM »

Model Number 102
Event Date 06/21/2006
Event Type Malfunction
Event Description
Additional information was received indicating the patient wants to have his vns explanted. The patient noted that the vns did not help his depression. The patient confirmed the physician indicated to him that the "vns was not working anyway. " the patient intends to pursue explant of the vns however it is unknown if it will occur at this time.

Event Description
It was reported by the patient that he had been having worsening depression for about a year to a year and a half. The patient also stated that he had been having suicidal thoughts since being implanted with vns however it is unknown if these had worsened since implant or pre-existing. Per the patient, the physician had previously informed him that his vns "wasn't charged" or was "malfunctioning" however he did not have any further information. The patient stated that he still feels stimulation and that it has not changed at all so he did not believe there was an issue with the battery. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2355590
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« Reply #281 on: March 15, 2018, 02:06:46 AM »

Model Number 102
Event Date 03/01/2012
Event Type Malfunction
Event Description
Manufacturer follow up with the treating psychiatrist revealed the patient's vns is operating properly. The patient has not been seen since (b)(6) 2012 due to financial issues. The patient is on several medications for her depression. The patient's depression does fluctuate due to outside personal stressors, and the reported increased depression is not felt to be due to the vns. The vns has been helpful for the patient. The reporter also later indicated to the manufacturer that the vns was also felt to be helpful for her depression.

Manufacturer Narrative
(b)(4).

Event Description
Reporter indicated that since she had intentionally lost weight approximately six months ago, her vns was causing muscle twitching and painful stimulation. The reporter currently does not feel the vns stimulation in her neck but at the clavicle, and reported that her depression has increased since the events began. A vns battery life estimate performed by the manufacturer resulted in approximately 3. 30 years remaining, indicating generator end of service is unlikely. Attempts for further information from the treating psychiatrist are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2763617
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dennis100
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« Reply #282 on: March 16, 2018, 01:43:13 AM »

Model Number 102
Event Date 08/14/2012
Event Type Injury
Event Description
It was reported by a surgeon that the patient was being scheduled for explant. The surgeon indicated that the device had never really helped with her depression and the patient had been experiencing problems with hoarseness during stimulation and shortness of breath so the patient was being explanted. Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012 when the physician reported that it is unknown when the lack of efficacy, hoarseness, and shortness of breath first began. He also stated that it is unknown what the cause of the lack of efficacy is. It was also unknown what the relationship between hoarseness and the shortness of breath to vns was as well as whether or not they were occurring with stimulation. The physician stated that no interventions have been taken and it was unknown if causal or contributory programming or medication changes preceded the onset of the shortness of breath. The patient does not have a medical history of shortness of breath pre-vns. A battery life calculation was performed on (b)(6) 2012, which showed 5. 16 years remaining until neos=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2743583
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« Reply #283 on: March 20, 2018, 01:20:48 AM »

Model Number 102
Event Date 08/26/2011
Event Type Injury
Event Description
(b)(4). Attempts for additional information have been unsuccessful.

Manufacturer Narrative

Event Description
On (b)(6) 2012, it was reported that the patient's settings were changed. The patient's neurologist felt that the patient had pseudoseizures and anxiety. The patient was requesting explant. Surgery is likely but has not taken place. Attempts for additional information have been unsuccessful.

Manufacturer Narrative
Analysis of programming history.

Event Description
On (b)(6) 2012, this patient's settings were adjusted to reach more efficacious levels. Diagnostics on this day were within normal limits. On (b)(6) 2012, the patient was reportedly having an increase in seizures, lack of efficacy, voice alteration, and an increase in depression. The patient reported potentially having the explanted due to the adverse events.

Event Description
Clinic notes regarding this vns patient were received on (b)(6) 2012. Notes dated (b)(6) 2012 indicated that the patient presented with a major complaint of frequent migraines. These were occurring so often that the patient became dehydrated and was hospitalized numerous times in the past year. The patient had to have iv fluids and narcotics in order to control them. The patient and her husband both felt that the patient was having more migraines since vns implant. The patient came in to request that the device was turned down or off to see if this may have some effect on her migraine frequency. The patient's headaches were now almost daily and severe two or three times a week. The patient was largely in the right side of her head and was associated with an inability to stand noise, light, movement, nausea, and vomiting. The patient was seeing a physician for the migraine treatment at least one per month (or every other month). It was also noted that the vns had not seemed to help the patient's seizures. The exact seizure frequency was not known but that patient averaged, at least, anywhere from two to five generalized tonic-clonic seizures per month and six complex partial seizures per month. The patient believed these were less now than before although the previous frequency estimate was somewhere between four and five per month. The patient's settings were altered at this appointment. The physician noted that the changes would be turning the device to less than therapeutic levels. The physician also seriously doubted that it would cause any migraines. It was noted that the patient's medications were all associated with increase seizures in patients predisposed; however, the patient had more of a problem with the pain from migraines. The patient's settings from (b)(6) 2011 were provided. It was also noted that patient wanted her vns turned down or off. The patient's migraines seemed worse with vns. Notes dated (b)(6) 2011 indicated that the patient's severe migraines were worse and more frequent and that the patient had been hospitalized with migraines with dehydration. The patient's seizure and headache frequencies were also noted. Notes dated (b)(6) 2010 also provided seizure and headache frequencies and stated that the migraines may last up to four days. The patient felt that the partial seizure frequency had decreased. Notes dated (b)(6) 2010 indicated the patient's seizure frequency, but the text was illegible. It was written that the patient felt that the partial seizure frequency decreased. The patient's migraines may last up to four days.

Event Description
Per the return product form, the device was explanted because the patient did not want it. Product analysis of the explanted generator found that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿pain¿ and ¿pain with stimulation¿). 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 generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with that which typically exists following an explant procedure. No other 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. 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. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Since a portion of the lead assembly (body) including the electrodes array section was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead.

Event Description
Clinic notes dated (b)(6) 2013 were received indicating that the patient was referred for removal of her vns. The patient had three grand mal seizures per month on average. The device was disabled in (b)(6) 2012. The patient was currently having one grand mal seizure and one partial complex seizure per week. The patient had significant a significant medical condition of depression. The patient also presented with headaches. The headaches occurred daily. Associated signs and symptoms included phonophobia, photophobia, and scalp soreness. The headaches were incapacitating. Stress, phonophobia, and photophobia were possible exacerbating factors. The patient is continues to have migraines which she takes morphine for. The physician would like to find a different non-opioid medication to control the patient¿s headaches. Per the physician morphine had the tendency to lower seizure threshold in some patient and can cause rebound headaches.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2773585
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« Reply #284 on: April 05, 2018, 12:50:53 AM »

Model Number 102
Event Date 05/22/2012
Event Type  Injury   
Manufacturer Narrative
Analysis of programming history performed. Describe event or problem: corrected data: it was inadvertently not reported on the initial report that the generator had reached end of service.
 
Event Description
Attempts for product return have been unsuccessful as it was reported by the hospital that the generator was not received for return following the surgery. Attempts to the treating physician have been unsuccessful to date. Additionally, it was noted on (b)(6) 2012, that the patient's generator had reached end of service and could no longer be interrogated. A review of available programming history revealed that diagnostics in may 2012 were within normal limits.
 
Event Description
On (b)(4) 2012 , the manufacturer received some of a vns patient's clinic notes from office visits dated (b)(6) 2012, and (b)(6) 2010. On (b)(6) 2010, it was indicated that the patient had four different seizure types. The first seizure was a generalized tonic-clonic type seizure usually occurred when the patient was sleeping with a frequency of 5-7 per month. The second type of seizure was myoclonic and occurred sporadically. The third type of seizure was starring episodes and the patient's caregiver has not noticed this type of seizures recently. The last type of seizure is atonic where the patient would suddenly drop to the floor. Her psychiatric parameters were reviewed and they appeared to be normal and the patient was negative to anhedonia. The vns device was interrogated and all settings appeared to be normal. There was no indication of a high lead impedance or a battery failure. On (b)(6) 2012, it was stated that the patient developed uncontrolled clinical semiology indicative of depression. This event is said to have occurred after the office visit on (b)(6) /2010, as there were no signs of any abnormal psychiatric behavior during that visit. The patient is not able to remember how to do basic activities such as controlling the temperature of water using a shower faucet. The frequency of her first type generalized tonic-clonic seizures was three during the last 30-40 days. The patient had increase starring episode compared to her previous office visit. There was no information about the myoclonic and atonic type of seizure indicated during the previous office visit. Interrogation results of the vns indicated no high lead impedance or battery failure. Per the physician's note, the patient is "rapidly approaching end of service based on her settings. " the notes also indicated that the patient has a medical history positive for anhedonia and the patient is oriented to time, place, person and situation. At that time the patient was being referred for a psychiatric consultation. On (b)(6) 2012, the patient's vns device was checked and the patient's mother thought the device was not working as the patient has started to have more frequent seizures in the last few months leading up to the appointment on (b)(6) 2012. The patient has 1-3 generalized grand tonic clonic seizures every week and occasional myoclonic seizures. There was no information provided on the starring episodes and atonic seizures. There was no psychiatric assessment of the patient and no information of depression indicated on clinic notes dated (b)(6) 2012. The patient was referred for and underwent revision on (b)(6) 2012. Attempts for additional information and product return are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2904808
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« Reply #285 on: April 22, 2018, 01:04:10 AM »

Model Number 304-20
Event Date 06/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2013, this patient reported that she was experiencing pain just above the generator site (related to the previous chest pain) and that she had been to the er numerous times for this discomfort. The pains reportedly began one week prior. The patient also indicated that this was in addition to the breathing problems and chest pains that began with vns implant. When the patient was at the hospital, x-rays were taken with no noted issues, and there was no infection. The patient was given pain medication. The patient noted that the device was previously turned off. This morning the settings were turned down, and the issues did seem to improve. Attempts for additional information have been unsuccessful.
 
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient was hospitalized for several days due to shortness of breath. The patient was admitted to the hospital on (b)(6) 2014. The patient reported experiencing pain at her generator site while hospitalized but states that the pain had since resolved. The patient was also having seizures frequently. While hospitalized, the patient¿s device was found to be disabled. The neurologist at the hospital stated that the patient was suffering from depression and was taking too many aeds. Further follow-up revealed that the patient was seen by her following neurologist. The patient reported that her device had been disabled for two months prior to the office visit and that she was experiencing pain. The neurologist did not believe the pain was related to vns as the pain was not occurring at the patient¿s implant sites. After her office visit, the patient went to the emergency room due to a seizure on the bus that caused facial lacerations.
 
Event Description
On (b)(4) 2013, it was reported that this patient wanted her device removed. The patient reported that she developed a blot clot in the left neck. She was informed by her surgeon that the she bled quite a bit in surgery and had to be transfused intraoperatively. Three days after implanted, the patient began to experience frequent chest pains, shortness of breath, and difficulty speaking. She reported that she saw a pulmonologist who performed a bronchoscopy and informed her that her left vocal cord is almost completely paralyzed and that he could see the lead next to the vocal cord. The patient was last seen on (b)(6) 2013 at which time her settings were adjusted. (increased settings have not affected her chest pain and shortness of breath adversely: it was no worse and no better. ) attempts for information have been unsuccessful. Surgery is likely and will be captured in mfr report #1644487-2013-01510. The patient had earlier reported that two days after her system was implanted she went to the hospital because she could not breathe or swallow. The patient was turned on one month later. The patient indicated that the swallowing issue was only occurring a couple of times per week and not necessarily coinciding with stimulation on times. The breathing issue occurred all of the time and was worse with stimulation. The patient also experienced painful magnet stimulation at the electrode site (magnet output current: 1. 0 ma). The patient also had incidents of pain at the generator site for the past two to three months. The patient did not experience any trauma. At the hospital, her vitals were noted to be fine and everything was okay. The patient¿s physician was unable to provide information as to the cause of the events. The patient also reported that a ct performed after surgery showed a blood clot at the lead site. Follow-up at a patient appointment in september showed that the pulsewidth and frequency were too high. Once the settings were adjusted, the patient was fine. Follow-up with the surgeon¿s office showed that the patient was seen for implant and again in (b)(6) for post-op follow-up and one more time in (b)(6), at which time she reported the pain and swallowing; however, these were determined to be only the result of the patient¿s settings. At the follow-up appointments, the patient was healing well without any complications. Follow-up with the neurologist showed that the patient was doing well and was seen in (b)(6)with no complaints. The patient was doing well with seizure control. The relationship of the blood clot to vns was unknown. The patient was on clonazepam, lamictal, keppra, lamotrigine, haproen, and vimpat at the time of the event. No causal or contributory medication changes precede the onset of the thrombosis. To the physician¿s knowledge, the patient did not have a medical history of thrombosis, and there were no pre/co existing medical conditions which may have contributed to the event. No medical interventions were taken. The patient was last seen on (b)(6) 2012, and reported no new symptoms or issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3122977
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« Reply #286 on: April 24, 2018, 01:03:29 AM »

Model Number 102
Event Date 11/08/2007
Event Type  Injury   
Event Description
On (b)(6) 2013 the physician¿s nurse stated that the vns was not working for this patient, the patient just never got better. The patient had severe side effects and just had a really rough time with vns. The patient¿s depression didn¿t get better. The nurse stated that she thinks it is related to his underlying illness, being treatment resistant. She also mentioned that he has a history of suicidal thoughts ongoing and some suicidal gestures. She mentioned that he started or continued to have suicidal thoughts very shortly after he was implanted and the vns was turned on. She said she thinks it was because he thought the vns was going to work for him and it didn¿t. The nurse stated that she looked over the patient¿s progress reports and she saw where the device was turned on at 5. 5 weeks and the patient didn¿t feel that his mood had changed. The patient was still feeling depressed and having a lot of side effects.
 
Event Description
On (b)(6) 2013, it was reported that the vns patient had to have the vns turned off due to severe side effects and he was still depressed. It was previously reported on (b)(6) 2007 that the patient has made suicidal gestures. Further follow up with the physician revealed that the gestures were not related to vns therapy. Additionally, the patient's treating medical professional indicated that patient was experiencing vomiting, nausea, dyspepsia and headache on (b)(6) 2008. The medical professional has stated that all these events can be related to vns. Even though the patient has had medical history of these problems, they appeared to be worsened with vns stimulation. An additional event of cognitive changes where the patient was entering dream states was reported. Follow up with the treating medical professional revealed that the event is believed not to be related to vns therapy, but likely related to the patient's underlying psychiatric condition. The patient is reportedly doing better with emotional freedom exercises and they are considering putting the patient on an anti-psychotic. An additional report was received that this patient is experiencing side effects from vns including difficulty breathing, migraine, photophobia, nausea, indigestion, and reflux. Good faith attempts were made for additional information, but were unsuccessful. Even though a response was not received regarding diagnostics results, investigation of a report of cognitive changes showed the device to be functioning properly on (b)(6) 2008. No additional information was received regarding the dyspnea and visual disturbances events. Additional information from the site indicated that diagnostics on (b)(6) 2008 showed the device to be functioning properly. The physician indicated that all events except migraines were present from the first stimulation. The migraines and photophobia events began after the output current was increased. The dyspnea and dyspepsia events are associated with stimulation on times. It appears the patient had reflux 10 years ago, and the gi symptoms reappeared with vns therapy. It appears that the cognitive changes had disappeared, and then recurred about 2-3 times in one week. An additional contributing factor to the migraines and photophobia is the patient's hypertension. Decreasing the pulsewidth has seemed to help these events. Medication is being administered for the dyspepsia and migraine events. The patient is still undergoing relaxation techniques and therapy. The programming history database was searched. The patient was last programmed to output=1. 75ma/frequency=30hz/pulse width=130usec/on time=30sec/off time=5min/magnet output=0ma/magnet pulse width=500usec/magnet on time=60sec on (b)(6) 2010. The last system diagnostics test was from (b)(6) 2009 which showed output=ok/lead impedance=ok/dcdc=3/eri=no. On (b)(6) 2012 a nurse stated that the patient's output current was increased from 1. 75 to 2. 25, signal frequency decreased from 30 to 25, and off time was increased on (b)(6) 2011. The patient's side effects then became intolerable. On (b)(6) 2011, they turned the device completely off after the patient had turned it off with his magnet for a trial period from (b)(6) 2011. The patient still has the device turned off at present and the patient has since felt better. Additional information was received on when a form dated (b)(6) 2011 from the physician stated that the patient's reflux/indigestion and migraines resolved after turning off the vns. The physician later reported that the lack of efficacy was first observed on (b)(6) 2007. The patient was noted to have severe refractory depression that has been and continues to be non-responsive to therapy, medications, and vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3118167
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« Reply #287 on: May 04, 2018, 01:15:17 AM »

Device Problem No Known Device Problem
Event Type  Injury   
Event Description
It was reported that this patient almost died after having the vns implanted, and spent almost an entire year in the hospital due to the vns, and was put on life support. It was stated that the patient is now permanently disabled because of it. The patient had never before been treated for depression, and the patient had the device implanted to treat her seizures, but not only did the device make her seizures become so bad they almost killed her, but it caused her to become severely depressed, which is something she had never been diagnosed with before. It was stated that the family has suffered great tragedy because of the device. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7472454
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« Reply #288 on: May 07, 2018, 01:10:51 AM »

Model Number 102
Event Date 12/01/2012
Event Type  Injury   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Clinic notes dated (b)(4) 2013 indicated that this patient was having 2-3 seizures per month (but up to 4 in a month) but could go 3-4 months without a seizure. Seizures occurred when the patient was stressed or upset. , the patient had seizures a few months ago due to her daughter¿s wedding. The notes indicated that the magnet did not appear to be helpful for 8 months. It was normally useful in aborting seizures. The device was last interrogated by this physician in (b)(6) 2010 when the patient was last seen. The patient had a previous procedure for a pulmonary embolism. The patient had events of deep vein thrombosis. The patient magnet and vns were not functioning 8 months. The recent worsening was likely due in part o the ns no longer functioning with the patient feels began 8 months prior. Notes dated (b)(6) 2010 indicated that the patient denied any suicidal thoughts but still had some bouts of depression, and settings were provided. Surgery is likely but has not taken place. A battery life calculation shows 0. 13 years remaining.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3373843
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« Reply #289 on: May 10, 2018, 12:57:51 AM »

Event Type  Malfunction   
Event Description
The initial reporter reported that the patient seemed to be desperate, sinking, getting worse; and needed immediate help. As the patient referenced was indicated for depression, the getting worse; likely refers to an increase in depression. It is unknown what the relationship of the increase is to pre-vns baseline levels. No other information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3389223
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« Reply #290 on: May 21, 2018, 12:53:13 AM »

Model Number 105
Event Date 09/01/2010
Event Type  Injury   
Event Description
Cyberonics vns - for epilepsy patients. Two surgeries. Two separate devices, worsening, depression. Device malfunction could be fatal. First vns - implant constantly malfunctioned left scar tissue caused death/resuscitation in operating room. Caused stroke 2 times, caused permanent damage to heart/body, second device caused permanent damage and could be end by death to my life. Nerve damage, permanent sensitivity to touch, damaged nerves/pain, heart problems, scar tissue. Neuropathy could result in death. Cyberonics recently called, and they stated the surgery never should have been done. Pt id: (b)(6). Chart # at operating room: (b)(6). Surgeon: (b)(6). Surgical operating room/extended adm: (b)(6) 2015. Csn: (b)(6).
 
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« Reply #291 on: June 08, 2018, 02:49:24 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 04/06/2018
Event Type  Injury   
Event Description
It was reported that the patient was experiencing an increase in depression that was attributed to the vns generator reaching end of service, or eos. It was stated that the device battery was completely dead and was unable to be interrogated. However, an implanted card was received by the manufacturer that indicated that the vns generator replacement surgery was prophylactic. Follow up with the company representative revealed that the he was able to interrogate the vns after it was explanted. The explanted product has not been received by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7557558
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« Reply #292 on: June 08, 2018, 02:50:04 AM »

Model Number 104
Device Problem No Known Device Problem
Event Date 04/30/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient was experiencing an increase in depression and was concerned her device was not working properly. The patient saw her psychiatrist and diagnostics were performed on her device. The diagnostics indicated that the device was functioning as intended with no noted anomalies or malfunctions. It was stated that her physician also believed the device was not stimulation as much as before. The patient stated that she was feeling okay again after the appointment. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7543759
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« Reply #293 on: June 09, 2018, 01:46:19 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 05/06/2014
Event Type  Malfunction   
Event Description
It was reported that the patient experienced increased depression and suicidal ideations, which were originally believed to be related to the vns battery being depleted. The patient was hospitalized for four days for suicidal ideations. The patient reported that her symptoms improved when her vns was functional, but her depression worsened after the battery depleted. The physician believed that the loss of vns therapy could have contributed to the suicidal ideations, but the patient's issues had several "layers" to them. However, it was later reported that the patient's device was still on and functional, which indicates that the increased depression and suicidal ideations were not related to low battery. Diagnostics were unable to be completed due to discomfort, and no changes were made to the settings. No further relevant information has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7509668
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« Reply #294 on: June 11, 2018, 12:32:21 AM »

Model Number 103
Event Date 03/01/2010
Event Type  Injury   
Event Description
It was reported that a patient wanted to have the device removed because it had migrated to one end and was protruding. The patient did not believe that it was effective in treating her depression. The patient's physician confirmed that the device did appear to be more visible in the patient's chest. There were no reports of trauma or manipulation of the device. The reason for the migration is unknown. The patient has been referred to a neurosurgeon. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1671173
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« Reply #295 on: July 06, 2018, 08:32:08 AM »

Model Number 102
Device Problem No Known Device Problem
Event Type  Injury   
Event Description
A patient reported that she was experiencing worsening depression and suicidal ideations. The patient's vns system was implanted in 2007 and had reportedly been helpful in managing her depression in the past. It was believed that the generator battery was dead, resulting in the worsening symptoms; however, the manufacturer's battery life calculation did not support a depleted battery, and recent device settings and diagnostics have not been received by the manufacturer to date. The patient was referred for generator replacement surgery, but surgery has not occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7573873
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« Reply #296 on: July 14, 2018, 02:31:34 AM »

Model Number 102
Event Date 08/04/2006
Event Type  Death   
Event Description
It was reported that the patient passed away on (b)(6) 2016. She was found deceased in her home. The physician reported that the patient had cps and gtc seizures along with morbid obesity and depression. The patient was presumably seizure free, according to the physician's report. An autopsy was not performed, but the generator and lead were explanted and discarded. The patient's last visit to her physician was on (b)(6) 2006, and the patient was receiving vns therapy at the time of death to the physician's knowledge. The patient was on topimate and lamotrigine at the time of death. The relationship of the death and vns was unknown since the cause of death was unknown, but the physician did not attribute the death to vns. Additional information was received from the national death index. The cause of death was: major cardiovascular disease, generalized and unspecified atherosclerosis, other obesity, unspecified depressive episode, unspecified epilepsy, unspecified asthma, and unspecified arthrosis. A sudep (sudden unexpected death in epilepsy patients) evaluation was performed based on information from the national death index, and the death was determined to be probable sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5983626
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« Reply #297 on: August 07, 2018, 01:06:33 AM »

Model Number 102
Event Date 08/04/2010
Event Type  Injury   
Event Description
It was reported through clinic notes dated (b)(6) 2010, that a physician noted that the pt's depression worsened when her device was not working previously. F/u was made with the pt's treating nurse who indicated that the pt's device had not been disabled at any other time other than at reported high lead impedance (reported in mfr. Report 1644487-2010-02012). The nurse also indicated that it is unk if the pt's depression ever elevated above pre-vns baseline as the pt sees a psychiatrist for her depression. Furthermore, if the pt experienced an increase in depression in the past, the nurse was not able to tell what contributed to the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2005792
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« Reply #298 on: September 07, 2018, 10:13:33 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/19/2018
Event Type  Malfunction   
Event Description
It was reported that a vns patient was feeling an increase in depression due to potential battery depletion. She stated her device has not been checked in a year. An estimate of battery life calculation was performed and did not support battery depletion. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7776421
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« Reply #299 on: September 09, 2018, 01:05:43 AM »

Event Date 11/01/2006
Event Type  Injury   
Event Description
An article titled "safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase i/ii proof of concept trial" was received and reviewed on 10/03/2011. During the review of the article, it was reported that 2 study participants experienced worsening depression, reportedly due to the device and stimulation. This mdr was submitted to report the worsening depression of the first participant. Attempts for add'l pt and event info have been unsuccessful to date.
 
Manufacturer Narrative
Citation: lange, gudrun, malvin n. Janal, allen maniker, jennifer fitzgibbons, malusha fobler, dane cook, and benjamin h. Natelson, "safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase i/ii proof of concept trial". Pain medicine 2011; 12: 1406-1413.
 
Event Description
Follow up was performed with the authors of the article. It was indicated that no other information, besides what was available previously in the paper, would be available for disclosure. Per the reporter, information was previously provided to the manufacturer on issues which the authors deemed to be significant; however this cannot be confirmed as patient information was not provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2324439
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