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dennis100
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« Reply #360 on: January 22, 2019, 06:31:02 AM »

Model Number 102
Event Date 01/20/2014
Event Type  Injury   
Event Description
It was reported that the recently implanted vns patient was seen for their first follow up appointment with the neurologist on (b)(6) 2014 where the device was programmed on for the first time. The patient returned home and subsequently began experiencing chest pain and went to the emergency room where the patient was diagnosed with heart block. A cardiologist referred the patient for pacemaker implant surgery. Although the cardiologist stated that the patient¿s heart block diagnosis was not related to vns, the neurologist continued to inquiry about a possible relationship between heart block and vns. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3679922
« Last Edit: January 31, 2019, 03:05:33 AM by dennis100 » Logged
dennis100
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« Reply #361 on: January 25, 2019, 09:48:52 AM »

Model Number 103
Event Date 01/01/2013
Event Type  Injury   
Event Description
A letter was received from the treating vns physician who reported that the physician is not aware of any evidence implicating that the patient's vns caused a cardiac dysrhythmia. The patient had structural abnormalities (as described in her ep study) that responded well to the ablation procedure on (b)(6) 2013. Since he is not convinced that there is a correlation between her cardiac rhythm and her vns, he was unable to provide additional information.
 
Manufacturer Narrative

Event Description
A cardiologist reported that the vns patient was going to undergo a cardiac ablation to correct an arrhythmia. She indicated that the arrhythmia may be related to vns but it also be related to the patient's seizures. She was not certain. Follow-up was performed with the cardiologist following the cardiac ablation. Clinic notes dated (b)(6) 2013 reported current diagnoses of seizures with epilepsy, syncope and collapse, and palpitations. The patient was noted to have ongoing problems with seizures progressing so the treating vns physician contacted the cardiologist. The patient was evaluated by the physician and cardiologist in the hospital and had a monitor. In spite of all of the efforts, she has was having ongoing seizures. She also was having palpitations on an almost daily basis which last up to 30 minutes. She had a treadmill stress test on (b)(6) 2013 and it did not show any evidence of ischemia. She did have questionable atrial arrhythmias on the treadmill at maximal stress. On her event monitor last summer, she had episodes of underlying sinus rhythm and she did have repeated episodes of atrial arrhythmias with atrial cycle lengths around 200 ms, some of which looked like flutter and some more looked like atrial fibrillation. Her rate would be in the 100-120 range. She said she was not taking anything at the time including an episode where her heart rate went to 150, and she says that she was absolutely not doing anything that would have caused that from a physiologic standpoint. Her echocardiogram last (b)(6) showed normal left ventricular function with no significant abnormalities. The vns physician indicated to the cardiologist that if nothing can be offered from a cardiac standpoint, she will need to see a neurosurgeon to resolve the issue. Review of the ecat strips, which the vns physician has performed on his patients who have underlying sinus bradycardia, with rates in the 60s and then tachycardia with rates around 100-120 with a:a intervals at times that look consistent with atrial flutter or atypical coarse atrial fibrillation. The patient has no previous history of significant trauma, and no previous interventional or invasive cardiology procedures. The patient had an event monitor in (b)(6) 2012, echocardiogram (b)(6) 2012, treadmill test (b)(6) 2013; left ventricular ejection fraction: via echo. Cardiac analysis shows regular rhythm, s1 and s2 normal, no s3 or s4, apical impulse not displaced, no murmurs, no gallops, and no rubs detected. The cardiologist's impression indicated atrial arrhythmias, possible atrial flutter, and palpitations. The patient had a scheduled electrophysiology study and possible ablation scheduled for the next week. The cardiologist suspected that the patient may have a tendency to atrial fibrillation. The patient had (b)(4) study for atrial arrhythmias, possible atrial flutter, syncope, seizures, palpitations, normal lv fxn, and vns. She had successful ablation for avnrnt and aflutter. Follow up was indicated for patient to have a 24 hour holter monitor in 2 months with office visit to follow in 3 months. Additionally, the cardiac cath report dated (b)(6) 2013 was received. She was "referred as she was having clinical events of tachycardia related to her seizure medications. At this point intervagal nerve stimulator at this point. She is also having recurrent symptoms that are concerning for possible arrhythmia, and monitors have shown abnormalities including tachycardia consistent with an arrhythmia, possibly atrial flutter. If there is not an arrhythmogenic component to her symptoms, then it is felt that she would be facing neurosurgery to try and address the focus of her seizures. Subsequently, after discussion and documentation of arrhythmias, she has elected to proceed with ep study and possible ablation. It is felt that if there is no arrhythmias induced, then the following consideration would be anatomical ablation of atrial flutter". During the ablation procedure, "atrial tachycardia was seen that had rates of 140 beats per minute. Due to this uncertain clinical scenario as it should not be reinduced. The patient underwent successful ablation for two forms of psvt (avnrt and aflutter). The cardiologist indicated in the notes that it is believed the patient was having both of these arrhythmias clinically and would benefit from ablation. The patient's medications were continued at that time. Attempts for additional information regarding these events to the treating vns physician have been unsuccessful to date. The relationship of the arrythmia, increased seizures and syncope to vns are unclear to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3018075
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dennis100
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« Reply #362 on: January 31, 2019, 02:45:12 AM »

Model Number 102
Event Date 11/10/2008
Event Type  Injury   
Event Description
It was reported a vns therapy patient passed away. The patient experienced cardiac adverse events 4 months prior to the patient's death. Follow up with the medical professionals did not reveal an exact cause of death as no details of the patient's passing were provided by the patient's family; however, the treating physician stated it was "probably not related" to vns therapy. Follow up with the county medical examiner's office did not know the cause of death as an autopsy was not performed. Manufacturer reviewed available programming/diagnostic history and the most recent device diagnostic test was performed in early 2007, at which time the results were with in normal limits. A battery life calculation revealed the patient's generator was 6. 01 years until the elective replacement indicator read "yes". Good faith attempts to obtain the cause of death listed on the patient's death certificate, as well as the patient's vns therapy system for analysis, have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1398522
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dennis100
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« Reply #363 on: February 08, 2019, 01:34:14 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Event Description
It was reported via social media comment by the patient that she experienced vocal cord damage and permanent heart issues. The reported vocal cord damage was reported in mfg. Report #1644487-2019-00173. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8291615
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dennis100
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« Reply #364 on: February 08, 2019, 01:34:43 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/12/2018
Event Type  Injury   
Event Description
It was reported that the patient has had two months of drop episodes. It is unknown if the drop episodes are seizures or are caused by syncope. It was also reported that when the patient was seen by cardiology, her heart rate decreased from 60 bpm to 40 bpm while stimulation was received when the patient was sitting. When the patient was standing, the heart rate decreased from 100 bpm to 80 bpm. Programming history was reviewed for the generator. No anomalies were seen. Device history records were reviewed for the generator. The device passed all specifications prior to distribution. The patient was referred to wear a holter monitor for 24 hours. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8214784
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dennis100
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« Reply #365 on: February 09, 2019, 04:10:13 AM »

Model Number 102
Event Date 08/21/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received when the physician reported that no causal or contributory programming or medication changes precede the onset of the syncope and dizziness. The patient was seen by a cardiologist and diagnosed with neurocardiogenic syncope. The physician stated that there is no relationship between the patient¿s vns and the syncope and dizziness.
 
Event Description
It was reported that the patient began having black out spells and dizziness. A nuclear stress test was performed and was within normal limits. An echocardiogram was done which showed his ejection fraction has decreased and then the patient was placed on a holter monitoring device to record heart activity with the events. The patient will be monitored for a month. The dizziness and blackout spell were happening everyday several times per day and was not associated with a time or day nor with any body positioning (standing or rising, or sitting). The cardiologist of the patient believes it is related to vns and he turned the stimulation down. It was believed that this helped with the events but the patient was still experiencing symptoms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4210094
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dennis100
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« Reply #366 on: February 18, 2019, 01:38:20 AM »

Model Number 104
Event Date 01/01/2013
Event Type  Injury   
Manufacturer Narrative
Pt ag: age at time of event: the initial report inadvertently reported the age incorrectly. Date of event: the initial report inadvertently reported the event date incorrectly. The physician reported the patient developed the congestive heart failure over the past few years.
 
Manufacturer Narrative

Event Description
Follow-up with the physician revealed that the device was disabled on (b)(6) 2015. The physician stated it was unknown whether it will be re-enabled at a future date. The patient reports that dyspnea decreased after disabling. The patient stated they feel better overall after disabling. The device was turned off to prevent serious injury related to the report of tachycardia.
 
Event Description
It was reported that the vns patient was experiencing the following events which the physician believed were related to vns: congestive heart failure, stomach ulcers, tachycardia not associated with stimulation, dyspnea not associated with stimulation, and voice alteration. The physician elected not to disable the patient¿s device due to its effectiveness in reducing the patient¿s suicide attempts and depressive episodes. The physician noted that vns is not the source of these issues but believed that may be contributing to the patient¿s events. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4623006
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dennis100
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« Reply #367 on: February 22, 2019, 08:37:10 AM »

Model Number 101
Event Date 03/01/2015
Event Type  Injury   
Event Description
It was reported that the patient's primary care physician referred the patient to the neurosurgeon due to cardiac irregularities. The patient reported that she believes the cardiac irregularities may be related to vns. The neurosurgeon's office indicated that the patient called to schedule an appointment; however, never made the appointment. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
 
Event Description
Follow up with the patient¿s neurologist¿s office indicated that they have not seen the patient in three years and did not have any information on the reported cardiac irregularities.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4664555
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dennis100
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« Reply #368 on: February 23, 2019, 02:58:11 AM »

Model Number 102R
Event Date 03/01/2015
Event Type  Injury   
Event Description
On (b)(6) 2015 it was reported that the patient was hospitalized and that the patient began having an arrhythmia. The cardiologist thought that the vns was causing it. This was described as "long pulses. " they used the magnet to shut off the device and reported that the arrhythmias went away. The neurologist requested that the device be disabled. The physician wanted to wait on performing diagnostics, that he would perform that later. Good faith attempts for further information from the physician were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4647805
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dennis100
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« Reply #369 on: February 27, 2019, 09:02:29 AM »

Model Number 102
Event Date 06/23/2009
Event Type  Death 
Event Description
It was reported that the patient passed away on (b)(6) 2009 from congestive heart failure. The relationship between the patient's death and vns is currently unknown, and attempts for additional information have been unsuccessful to date.

Event Description
Additional follow up was performed with the patient's funeral home who indicated that the device was unavailable for return; however they were uncertain if it was explanted or discarded. Attempts for additional information regarding the patient's death have remained unsuccessful.

Event Description
Additional information was received from the physician's office indicating that they had lost the patient's medical history during a move and would be unable to provide any more information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2485449
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dennis100
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« Reply #370 on: February 28, 2019, 03:45:30 AM »

Model Number 102
Device Problem Insufficient Information
Event Type  Injury   
Event Description
It was reported that the vns patient's device was disabled years ago due to arrhythmia. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Review of the available programming and diagnostic history showed that the device output current was programmed off on (b)(6) 2009; however the magnet output current remained programmed on.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4956556
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dennis100
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« Reply #371 on: March 05, 2019, 07:50:52 AM »

Model Number 105
Event Date 05/08/2015
Event Type  Injury   
Manufacturer Narrative
Suspect device udi, corrected data: the initial report inadvertently did not report this information. (b)(4).
 
Event Description
It was reported that the patient experienced an increase in heart rate associated with vns stimulation. The physician elected to turn down the output current from 1. 5ma to 1. 25ma to see if this would result in a decrease in heart rate. It was also noted by the patient that the stimulation on times made the patient feel anxious. The physician thought this could be related to the heart rate increase. Good faith attempts for additional, relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4789594
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dennis100
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« Reply #372 on: March 08, 2019, 02:25:33 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported via an article received by the manufacturer that this patient experienced sleep apnea and arrhythmia associated with stimulation. It was stated that this patient has mitochondrial cytopathy and pharmacoresistant epilepsy and was evaluated for suspected sleep disordered breathing. The patient¿s parents noticed pauses in breathing during sleep and reported excessive daytime sleepiness (eds). It was found through a night polysomnography that the patient had additional central hypopneas consisting of episodes of decreased airflow without desaturations. Heart arrhythmias happened during breathing events. Practically all of breathing events and heart arrhythmias were periodic and corresponded to vns stimulation (every 3 minutes), and persisted for the duration of the stimulation, and came to an end with vns deactivation. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8298248
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dennis100
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« Reply #373 on: March 15, 2019, 02:11:06 AM »

Model Number 103
Event Date 08/01/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that adjusting vns settings has recently caused the seizures to worsen. The patient reported that the physician has not programmed the device off despite the vns "affecting her heart". It is unknown whether or not the increase in seizures is above the patient's pre-vns baseline frequency. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Further follow-up with the physician revealed that the patient continues to have more seizures, but it was suspected that these were non-epileptic events; therefore, no medication changes were made. The vns was interrogated and found to be working as intended with ifi - no. Device settings were reprogrammed on (b)(6) 2015 and the patient tolerated this well. It was reported that the patient has heart conditions that are unrelated to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5141418
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dennis100
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« Reply #374 on: March 15, 2019, 02:11:51 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/10/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported on (b)(6) 2015 that the patient began experiencing discomfort in the chest that day or the day prior. She was being seen by her primary care physician on (b)(6) 2015. The patient's vns device was checked a couple days prior, and everything was reportedly okay. The patient was undergoing blood work to confirm that this was not cardiac in nature, but it was initially not clear on the relationship to vns. Upon follow-up, the treating neurology nurse practitioner reported that the patient had a myocardial infarction. Attempts to the patient's primary care physician have been unsuccessful to date. The nurse practitioner was unable to provide further information. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient has a "leaky heart valve" which is believed to be unrelated to vns per the neurologist.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5154890
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dennis100
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« Reply #375 on: April 07, 2019, 04:12:31 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/05/2007
Event Type  Injury   
Event Description
It was reported by the patient that they experienced heart fluttering since the vns was implanted. The nurse at the patient's neurologist's office indicated that they had not received a report from the patient regarding heart fluttering to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8405111
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dennis100
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« Reply #376 on: April 08, 2019, 03:28:31 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/23/2018
Event Type  Injury   
Event Description
The patient reported that she was having a heart issue with vns stimulation. Per the neurologist, it was unconfirmed if the patient was having a heart issue. The patient had been sent for cardiac workup but no results were available. Programming history was reviewed and no anomalies were seen. No diagnostics were available. Device history records were reviewed for the generator and the device passed all specifications prior to use. No additional information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8382211
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dennis100
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« Reply #377 on: April 14, 2019, 01:52:54 AM »

Model Number 102
Event Date 10/09/2012
Event Type  Injury   
Event Description
A health history form dated (b)(6) 2012 indicated that the patient has or had the following symptoms within the past year: irregular heart beat, rapid heart, and fainting. The relationship to these events and vns was not indicated. Of note, the patient also has a history of high blood pressure, high cholesterol and chest pain. It is unknown what interventions have been taken. Attempts for additional information have been unsuccessful to date. The form also indicated the patient has or had cancer within the past year, as reported in mfg report number: 1644487-2012-03443.
 
Event Description
Information was received from the patient's currently treating physician reporting that they cannot provide additional information as they just started treating the patient on (b)(6) 2012. Attempts for information from the previously treating physician were unsuccessful as the physician is no longer practicing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2883404
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« Reply #378 on: May 05, 2019, 01:28:00 AM »

Model Number 103
Event Date 01/01/2011
Event Type  Injury   
Event Description
It was reported via clinic notes received that the pt has obstructive sleep apnea, asthma, and a previous electrocardiogram indicated an arrhythmia. It was noted on the clinic notes that a recent electrocardiogram showed a "sinus arrhythmia"; however, it is not known if this is the same arrhythmia or a separate one. The relationship of these events to vns is not known. Diagnostics dated (b)(6) 2011 indicated normal device function. Attempts for additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2316734
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« Reply #379 on: May 09, 2019, 07:50:53 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2016
Event Type  Injury   
Event Description
It was reported by the patient that he had been ¿going out¿ and that he wasn¿t sure if the vns was causing it. He said that he could also just be falling asleep, it could be a seizure or it could be his medication, but he was concerned that the vns and/or the vns and his pacemaker could be causing it. No further relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: the following information was inadvertently not reported on the initial mdr "it was reported by the patient that he had been having problems with the vns. He said that it seemed to be going off randomly all the time and that when it went off it caused pain and voice alteration. He said that he would also get dizzy and he didn¿t know if that was related to the vns or seizure. " event problem cds, corrected data: the patient codes were inadvertently not included in the initial mdr (b)(4).
 
Event Description
It was reported by the patient that he had been having problems with the vns. He said that it seemed to be going off randomly all the time and that when it went off it caused pain and voice alteration. He said that he would also get dizzy and he didn¿t know if that was related to the vns or seizure. The patient reported his device was being explanted because it wasn't working because he could now feel stimulation. The patient also indicated that he had a pacemaker for atrial fibrillation. The patient then called and said that his painful stimulation was definitely occurring more often than what he expected it to and that he wanted the company representative to come disable it. The patient then reported to the company representative that nobody had programmed off the device or interrogated it since the last, but that he had talked to his primary care physician and the painful stimulation had resolved. No further relevant information has been received to date. No related surgical intervention has occurred to date.
 
Event Description
It was reported by the physician's office that the patient did not have a good memory. It was also indicated that sometimes he "sometimes just needed to speak to someone to calm him down" after his call to the manufacturer was described. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6503540
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« Reply #380 on: May 10, 2019, 02:36:14 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
Article titled "a rasmussen encephalitis, autoimmune encephalitis, and mitochondrial disease mimicker: expanding the dnm1l-associated intractable epilepsy and encephalopathy phenotype" was reviewed. Within this article, it was reported that the vagus nerve stimulator (vns) was placed with a decrease in seizure frequency but was complicated by sinus bradycardia and first-degree atrioventricular block requiring device removal. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8530085
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« Reply #381 on: May 10, 2019, 02:37:23 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/22/2019
Event Type  Injury   
Event Description
It was reported that during a vns generator replacement surgery, the surgeon had inadvertently cut the patient's vns lead. After the generator and lead were explanted, the surgeon attempted to find a good location on the vagus nerve to implant the new lead. At this point, the patient's heart rate dropped and the patient was administered epinephrine to bring the heart rate back up. It was noted by a nurse that the patient lost approximately 500 ml of blood. However, it was not stated that this constituted a significant amount of blood loss. It was noted that the patient was also having trouble breathing. The surgeon did not feel comfortable with continuing the surgery at this time and sent the patient to icu. No new products were implanted into the patient during the surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8566829
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« Reply #382 on: May 11, 2019, 03:58:05 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2005
Event Type  Injury   
Event Description
It was reported by the patient that her vns had been disabled since 2005 due to it ¿messing with her heart¿. The programming history available to the manufacturer was reviewed for the patient¿s generator. All diagnostics data was within normal limits throughout the available data. Review of the available programming history did not reveal any anomalies that indicated device malfunction. Follow up was performed with the patient's last known treating vns physician. Information was received from the physician¿s office that determined that there was no record of the patient in their system. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8552203
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« Reply #383 on: May 11, 2019, 03:59:22 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2018
Event Type  Malfunction   
Event Description
It was reported that a patient was experiencing an increase in seizures clusters since having her vns replaced. The patient used to have an average of 6 seizures/month but reportedly had 13 cluster seizures in the previous night alone. Magnet mode stimulation was attempted to help but did not do anything. It was also stated that autostimulation was programmed but did not work for the patient due to the patient's low heart rate. The patient had not been seen by the neurologist and would not be seeing the neurologist until (b)(6). The nurse stated she had labs run on the patient to determine a cause but nothing was found. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8519876
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« Reply #384 on: May 18, 2019, 01:33:15 AM »

Event Date 09/08/2011
Event Type  Injury   
Event Description
It was reported by the nurse that the pt had been implanted with a cardiac pacemaker. It was not known if the cardiac issues were unrelated to vns, but the site inquired into how to check the vns following his surgery. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2276566
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dennis100
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« Reply #385 on: May 20, 2019, 10:05:02 PM »

Lot Number 567565
Device Problem Magnet failure
Event Date 01/16/2008
Event Type  Malfunction   
Event Description
Reporter indicated that a magnet was used to inhibit stimulation during external defibrillation. Following the event, the magnet was reported to not stop seizures like it had in the past. Good faith attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1810749
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dennis100
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« Reply #386 on: May 20, 2019, 10:05:38 PM »

Model Number 302-20
Event Date 03/01/2008
Event Type  Malfunction   
Event Description
Reporter indicated that patient was in the hospital for three weeks and in that time an external defibrillator was used. Subsequent diagnostics testing revealed high lead impedance, indicating a lead malfunction. Patient later underwent a full revision surgery. Explanted lead and generator were returned to manufacturer, however, that analysis is not yet complete.
 
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1037190
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dennis100
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« Reply #387 on: May 20, 2019, 10:06:24 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/26/2017
Event Type  Death   
Event Description
It was reported by the medical examiner that the patient had passed away. She had called to see if a company representative could come and check the device as she wanted to see if the patient was having a seizure or cardiac issue at the time of death. It was explained that the vns did not have those capabilities. It was confirmed the generator was explanted and the lead was clipped in the chest pocked, but not removed from the neck. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
The explanted vns generator was received by the manufacturer for analysis" was inadvertently left off of the initial mfr. Report. (b)(4).
 
Event Description
The medical examiner's office was contacted and it was reported the cause of the patient's death was hypertensive cardio vascular disease. It was also noted the patient did have a "bad heart". When speaking to the medical examiner directly, she stated this was the only conclusion she was able to draw based on the limited amount of information available. She explained the patient was quite decomposed and she was unable to assess the brain tissue to see if there had been any seizure activity which may have caused or contributed to the death. The explanted vns generator was received by the manufacturer for analysis and analysis was completed. The vns generator demonstrated the device was able to provide the expected level of output current during testing and the diagnostic values were as expected. There were no performance or any other types of adverse conditions found with the generator. The programming history database was reviewed. There were no anomalies found within the data available.
 
Event Description
The returned lead had analysis completed and approved. A small portion of the lead was returned measuring approximately 130mm. The condition of the returned lead portion was consistent with those that typically exist following an explant procedure. No obvious anomalies were noted in the returned lead portion. An evaluation could not be performed on the portion of the lead not returned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6593008
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dennis100
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« Reply #388 on: May 20, 2019, 10:07:08 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/29/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event have been determined as not related to vns therapy, but rather to the presence of the device.
 
Event Description
It was reported by that patient underwent a cardioversion procedure. Following the procedure the patient¿s generator pocket appeared infected and the skin around the generator was breaking down which caused the generator to extrude. The physician was concerned that the cardioversion procedure could have contributed to the generator extrusion. The patient was referred for surgery due to the generator extruding from the body. The patient's generator was explanted and no replacement occurred at that time. A manufacturing review was performed which showed the generator and lead were sterilized prior to distribution. No additional relevant information has been received to date.
 
Event Description
Further information was received from the physician that the patient did not have an infection at the generator site. The physician did not know what the cause of the extrusion was.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6552915
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dennis100
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« Reply #389 on: May 20, 2019, 10:08:56 PM »

Model Number 102R
Device Problem Energy Output To Patient Tissue Incorrect
Event Date 06/02/2017
Event Type  Malfunction   
Event Description
It was reported by the physician that patient's device settings were changed following a defibrillation. The settings were changed back by the physician. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7402670
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