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dennis100
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« Reply #210 on: June 29, 2018, 12:16:18 PM »

Model Number 102
Event Date 11/01/2011
Event Type  Injury   
Event Description
The pt reported that she was recently trying to work out and felt "weird. " she went to her cardiologist which revealed that she is experiencing severe tachycardia and bradycardia where her heart rate will lower to the 30's then jump to the 200's. She states that the cardiologist blames it on vns, but he does not know much, if anything, about vns. The pt's neurologist's office revealed that the pt has really benefited from vns. Both the neurologist and pt do not want to stop vns. As a result, the pt was going to go to another cardiologist for another opinion. The pt reportedly did have this problem prior to vns, but it was not severe. The cardiologist that reported the arrhythmia is reportedly not familiar with vns, according to the pt's neurologist. The pt wants to pursue other avenues to keep vns. The relationship of the arrhythmia to vns is currently unk. No causal or contributory programming or medication changes preceded the onset of the arrhythmia. Attempts for additional info has been unsuccessful thus far.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2364363
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dennis100
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« Reply #211 on: June 29, 2018, 12:17:34 PM »

Event Date 01/01/2003
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported in an article studying the side effects of pts implanted with the vns device, that two pts developed sinus tachycardia after the device was programmed on. This report will capture the second pt that developed sinus tachycardia and mdr 1644487-2010-00124 will capture the first pt. Good faith attempts to obtain additional info from the author of the article including pt and product identifiers, as well as whether or not this event has been reported to the mfr previously have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1580247
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dennis100
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« Reply #212 on: June 29, 2018, 12:18:16 PM »

Model Number 102
Event Date 08/01/2009
Event Type  Injury   
Event Description
Reporter indicated that the patient began to experience tachycardia once the device was programmed on. The patient does not have a history or a family history of cardiac issues. The medical professional indicated that some other symptoms were present that suggested arrhythmia and that some other traumatic events occurred prior to the start of the arrhythmia, but did not provide any specifics. The arrhythmia does not correlate with stimulation on times nor does it occur when device diagnostics are performed. The arrhythmia is not believed to be related to device stimulation; however, device stimulation exacerbates or co-currently contributed to the arrhythmia. The patient is taking several medications such as phenobarbital, rozerem, dilantin, and norco, however, there were no medication changes prior to the onset of the event. The patient's device has been programmed off and the arrhythmia has not occurred since the device was programmed off. Device diagnostics have not been performed, due to the patient's low settings. The patient will be scheduled for explant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1466251
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dennis100
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« Reply #213 on: June 29, 2018, 12:18:52 PM »

Event Date 01/01/2009
Event Type  Injury   
Event Description
Reporter indicated that the patient was experiencing occasional rapid heart rate, sometimes in excess of 120 bpm. It was stated that sometimes it seemed to be related to stimulation periods, but a relationship could not be confirmed. The patient has a history of extrasystole. All attempts for further information from the patient's treating physician's have been unsuccessful to date, thus the relationship between the tachycardia and vns therapy cannot be determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1471032
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dennis100
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« Reply #214 on: June 29, 2018, 12:19:27 PM »

Model Number 102
Event Date 01/01/2008
Event Type  Injury   
Event Description
It was reported that pt's vns has been turned off because she experienced tachycardia when it was on. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1148170
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dennis100
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« Reply #215 on: June 29, 2018, 12:20:26 PM »

Model Number 101
Event Date 11/30/2011
Event Type  Death   
Event Description
Additional information was received from the physician's office on (b)(4) 2012. The patient had hypertension and sleep apnea. The seizure history was unclear as the patient was not a reliable in reporting however it was suspected the patient had over 20 complex partial seizures per month. The patient had more than a 50% reduction in seizures with vns. It was unknown if the patient was ever enrolled in a study. The lead and generator were not explanted. The patient was receiving vns therapy at the time of his death. The patient's last office visit was (b)(6) 2011. The last know aed plasma levels were not available. The patient was worked up for resective surgery however the surgery did not occur. The death was not believed to be related to vns. A copy of the patient's death certificate was received where it was reported that the patient died in a nursing home/long term care facility. The patient was cremated. The patient died due to natural causes with malignant hypertension listed. The patient's seizure disorder was listed as a contributing condition. No autopsy was performed.
 
Event Description
It was reported that a patient passed away. The circumstances of the patient's death were unknown. Good faith attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
A sudep (sudden unexpected death in epilepsy) evaluation was performed through the (b)(6) which determined that the death met criteria for classification of possible sudep. There is no allegation or other information indicating that the death is related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2396727
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dennis100
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« Reply #216 on: June 29, 2018, 12:21:25 PM »

Model Number 103
Event Date 09/01/2011
Event Type  Injury   
Manufacturer Narrative
(b)(6). This was previously reported incorrectly per date of event.
 
Event Description
It was reported by a nurse that a vns patient recently experienced tachycardia events due to unknown reason. The patient was referred to the cardiologist and an ecg was performed; however at the moment it is unknown if vns is exacerbating the patient's cardiac events as good faith attempts to obtain further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2420595
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dennis100
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« Reply #217 on: June 30, 2018, 02:53:54 AM »

Event Date 01/01/1996
Event Type  Injury   
Manufacturer Narrative
Han p, frei mg, osorio i. Probable mechanisms of action of vagus nerve stimulation in humans with epilepsy: is a window into the brain [abstract]? epilepsia 1996;37 (5suppl):83s.
 
Event Description
It was reported in an article reviewed by manufacturer that vns patients are experiencing bradycardia and tachycardia with stimulation. A decrease in r-r variability is sometimes seen in patients at risk of sudden cardiac death. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1143661
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dennis100
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« Reply #218 on: July 06, 2018, 11:37:48 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 05/08/2018
Event Type  Injury   
Event Description
Information was received that the patient had not felt well since his recent vns replacement surgery. The patient visited the hospital and was diagnosed with post-ventricular tachycardia. The patient was prescribed medication to lower blood pressure. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7573433
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dennis100
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« Reply #219 on: August 11, 2018, 01:44:00 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was hospitalized due to tachycardia of about 180 bpm. The neurologist did not believe the increased heart rate correlated with the delivery of stimulation. The patient's normal and autostim output currents were programmed off on (b)(6) 2018. System diagnostics were reported to be normal. Of note, the vns was stated to be very efficacious for the patient. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7664430
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dennis100
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« Reply #220 on: September 07, 2018, 11:45:39 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/20/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a patient's caregiver believed the patient's vns was causing the patient's heart rate to increase up to 197 beats/min during seizures multiple times in a day, per the patient's pulse oximeter. It was further stated that the device had never helped with reducing seizure frequency, but has helped with reducing seizure intensity, which was seen when the battery died in the past. Device history records were reviewed for the patient's device and it was noted that the device had passed all quality inspections prior to distribution. Programming history for the patient's device was reviewed. The only data available was parameter data from a week after implant. No diagnostic data was available. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7790211
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dennis100
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« Reply #221 on: September 07, 2018, 10:28:41 PM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the patient that she wanted the vns lead removed due to high blood pressure. The vns generator was previously explanted to lack of efficacy, but the lead had remained implanted. The patient stated that she was experiencing baroreflex nerve damage and believed it to be due to the presence of the lead. The patient reported following up with physicians and all of the physicians believed that it was not related to the vns lead. The patient stated that this was only a recent issue and that she did not believe it was related to the surgery. No relevant surgery is known to have 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=7819434
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dennis100
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« Reply #222 on: September 08, 2018, 01:27:15 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7811075
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dennis100
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« Reply #223 on: September 27, 2018, 12:31:43 PM »

Model Number 102
Event Date 05/01/2013
Event Type  Injury   
Event Description
Information was received that suggested the patient¿s generator was possibly re-enabled since the initial report. A review of programming history for the patient¿s generator confirmed the device was re-enabled after the previously reported disablement. No additional pertinent information has been received to date.
 
Manufacturer Narrative

Event Description
It was reported that the patient had episodes that felt like she was about to pass out and when her heart rate was monitored by her caregiver it was over 200 bpm. It was reported that the patient¿s heart rate was higher when she laid on her right side than when lying on her left side. The increased heart rate was noted to be present for approximately 28 minutes. The patient was admitted into a cardiac unit. According to the patient¿s caregiver, the device was programmed off while hospitalized and that the heart rate ¿issues¿ went away. The device has not yet been programmed back on. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3286618
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dennis100
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« Reply #224 on: October 22, 2018, 02:53:27 PM »

Model Number 102
Event Date 02/14/2003
Event Type  Injury   
Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the patient's age at the time of the report event incorrectly.
 
Event Description
It was reported that since being implanted with vns in 2003, a vns pt has had an issue with her heart rate increasing during exertion, such as exercise, which is believed to occur with vns stimulation. The physician indicated that typically these episodes are brief and are limited to when there is exertion. During these episodes, the heart rate would increase to around 120 bpm. The pt was always just told to be cautions regarding this. However, about three weeks prior to the report while the pt was running on the treadmill, her heart rate went up to 200 bpm and stayed at that level for one or two hours. The pt is now being seen by a cardiologist. However, attempts for additional info have been unsuccessful to date.
 
Event Description
Clinic notes were received from the patient's physician. The notes dated (b)(6) 2012, reporting that the patient did have a cardiology evaluation, and it was determined that she has arrhythmia not related to vns. On (b)(6) 2012, it was reported that the patient was scheduled for arrhythmia follow up, and she has been stable. The previous notes on (b)(6) 2012, indicated that the patient reported going to the cardiologist on (b)(6) 2012, and her test was incomplete. The patient was experiencing tachycardia.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2434214
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dennis100
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« Reply #225 on: November 03, 2018, 12:54:25 AM »

Model Number 102
Event Date 12/14/2012
Event Type  Injury   
Manufacturer Narrative
 
Event Description
A vns treating neurologist reported that a vns patient was told on (b)(6) 2012 that the vns device needed to be "deactivated" because it was "provoking svt--supraventricular tachycardia. " the neurologist reported that he performed a literature search and found no evidence of this. The patient information was not provided, and attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received from the treating physician who reported the patient related to the event. The cardiologist reported that the patient needs to have her vns explanted because he/she believes that is the cause of the problem. The generator was turned off, and the cardiologist believes that is not enough. However, the treating physician does not agree and he does not believe the arrhythmia is related to vns therapy. Nevertheless, the cardiologist insists that the vns needs to be explanted, and therefore, the patient is scheduled to be explanted. Although surgery may occur in the future, the surgery has not occurred to date. Attempts for additional information from the treating physician have been unsuccessful.
 
Manufacturer Narrative
Age at time of event and date of birth, corrected data: this information was unknown at the time of the initial report. Sex, corrected data: this information was unknown at the time of the initial report. Brand name, corrected data: this information was unknown at the time of the initial report. Implant date, corrected data: this information was unknown at the time of the initial report. Model #, serial #, lot #, expiration date, corrected data: this information was unknown at the time of the initial report. Implant date, corrected data: this information was unknown at the time of the initial report. Device manufacturer date, corrected data: this information was unknown at the time of the initial report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2907841
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dennis100
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« Reply #226 on: November 10, 2018, 04:43:26 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/28/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported from the patient¿s mother that her daughter had some serious adverse events over the weekend. She mentioned that the patient started feeling dizzy and nauseous and she had pain and muscle spasms on the left side of her neck. The mother tried to tape the magnet over the patient¿s generator but she stated that it seemed like the vns shocked the patient. The mother then took the patient to the er and was able to successfully tape the magnet over the patient's generator to mitigate the symptoms that the patient was experiencing. She stated they then went to her neurologist but the mother was upset because the neurologist completely ruled out the vns device and did not address their concerns. She did say that the settings were changed and she was informed that the battery was low, so the mother felt that the issue could be occurring due to the low battery of the patient's generator. The mother was asked if there was any recent trauma and she stated that the patient had about 4 seizures from friday to sunday and the patient usually falls down due to her seizures and "runs into things all the time. " it was also reported that the patient also had extreme voice alteration. The mother also alleged that the ¿device misfired and patient is in pain, the device is shocking her. ¿ she stated that her daughter is having dizziness, her heart rate will be up in the 120 or in the low 40s. She stated that she was seen in the er on monday and they said to tape the magnet on it. She then stated that her daughter is weak and tachycardic. The er gave her a beta blocker. They have tried taping the magnet on it, but her chest is getting really hot. There were also changes in her voice. They had never had a problem with the vns before. The mother also alleged complaints of nausea and vomiting. The patient then stated she felt better when the vns was placed over the generator. The patient then said it was getting hot. So uncomfortable that she won¿t go to sleep. The father then said it was comfortable for 10-20 minutes and then goes vibrating and goes into legs and stomach. It also shocks all the way over to the left side of her chest. She stated that she felt bad enough to call the ambulance herself (herself being the patient). The patient was referred for replacement. Notes indicated the same allegations as previously mentioned including, that the patient reports electric shock sensation from the device to patient's neck and whole body, chest pain, magnet held in place over the device after going to the er, magnet made the device feel hot to the patient. Patient reports voice hoarseness of voice twitching on left side of the face, and headache all of which the family thinks is related to vns. The physician states recently she has been having more seizures. She is also having problems with the current device including feeling electric sharp like sensation in her chest and myoclonic movements in her neck and he is recommending a change in the vns device. The physician is recommending prophylactic vns device change so that the patient can have auto stimulation to help reduce her seizures specifically the electric shock-like sensation she is feeling and the cluster of seizures she is having. No surgery has occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8004870
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dennis100
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« Reply #227 on: December 07, 2018, 11:46:29 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/08/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient had an increase in seizures below pre-vns baseline frequency due to infection. The patient was hospitalized where he was found to be diagnosed with sepsis and tachycardia. The patient was admitted to the icu for several days. Review of the device history record showed that both the lead and generator were sterilized prior to distribution and there were no unresolved non-conformances prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8089667
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dennis100
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« Reply #228 on: December 07, 2018, 11:47:08 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/07/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
Initial report was that the patient experienced a heart rate of 120 beats per minute. Attempts for further information from the patient's physician were made and no further information has been received. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8121083
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« Reply #229 on: January 04, 2019, 11:57:05 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/25/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was diagnosed with supraventricular tachycardia (svt) shortly after the vns was implanted. The patient was concerned that the vns may be contributing to the condition. It was reported that the "automated mode" (which appears to be referencing the autostim feature) was turned off shortly after vns implantation due to a frequently increased heart rate. Ekg results were reported to be normal. It was reported that the patient followed up with an electrophysiologist who chose to place an implantable loop recorder to monitor the patient's heart activity. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8189636
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« Reply #230 on: January 05, 2019, 04:14:03 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/10/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient passed out. Upon following up with the doctor on the event the same day, the patient's heart rate was monitored, and when the patient swiped their vns magnet an asystole event occurred. During normal mode stimulations of the generator the patient experienced a rapid drop in heart rate, from resting 111bpm to 40bpm during stimulation. It was additionally reported, a few days after the asystole event, that the physician tried to program the generator back to previous settings, but the patient could not tolerate any output current due to coughing fits. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8135645
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« Reply #231 on: March 12, 2019, 03:57:28 AM »

Model Number 103
Event Date 01/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013, note that tachycardia under the patient's problem list. The relationship between the vns and tachycardia are unknown. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3579881
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« Reply #232 on: April 06, 2019, 02:55:27 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/05/2019
Event Type  Injury   
Event Description
The patient¿s mother initially reported that the patient¿s oxygen saturation level was 83 (percent) and the patient¿s heart rate was elevated to 130bpm. The patient¿s breathing was a little rapid and her fingers were semi-purple. Additionally, the patient¿s body temperature was 100. 8 f. Information was later received that the patient was treated for these symptoms at the er and these events were referred to as ¿respiratory infection¿ symptoms. The patient was reportedly feeling better after treatment but it was unknown if the patient was discharged. The patient¿s device was left off per the neurologist¿s request. After the implant surgery and lead impedance was normal at 1955 ohms. A review of device history records for the generator and lead shows that no unresolved non-conformances were found. The device met all specifications for release and were verified to have been sterilized prior to distribution. Follow up with the patient's neurologist determined that the er physician and neurologist assessed that the patient had pneumonia which was not believed to be related to vns therapy or surgery. Additionally, the increased heart rate, fever, and discoloration of skin were assessed to be symptoms of the pneumonia and were unrelated to vns as well. There was no mention of the rapid breathing or hypoxia. The neurologist reported that the most recent update regarding the patient was that she was doing much better. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8465064
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« Reply #233 on: April 07, 2019, 04:15:58 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2019
Event Type  Injury   
Event Description
It was reported that the patient experienced very low heart rates (reportedly in the 20s) to very high heart rates (reportedly in the 200s). The patient reportedly taped the magnet over the generator to inhibit stimulation which resolved the event until the magnet fell off. After this, the patient experienced a low heart rate and felt as if he would pass out. The neurologist reported system diagnostics results were within normal limits and the patient was at moderate settings. The physician was concerned that the lead was ¿tethered incorrectly¿ and requested x-rays be performed. The patient was referred for surgery to inspect the leaf. Ap neck and lateral chest x-rays of the patient were reviewed. The scope of the images did not include the generator and therefore the placement of the generator, the intactness of the feedthru wires, and complete lead pin insertion could not be assessed. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. A strain relief bend is present per labeling but no strain relief loop is present. Two tie downs are present with the initial tie down securing the first relief bend, and the second tie down securing a second relief bend. It could not be assessed if the lead was routed behind the generator due to the scope of the image. No sharp angles were identified in the visible portions of the lead. No gross discontinuities were identified in the visible portions of the lead. Additionally, the electrodes appeared to be placed normally on the patient¿s nerve. No obvious cause of the patient¿s heart fluctuations could be identified from the available images. A review of the available images did not reveal any anomalies that indicated device malfunction. Follow up with the patient's neurosurgeon determined that the patient had also passed out multiple times due to the low heart rate. Additionally, the patient's vns was disabled due to the arrhythmia after which the heart issues resolved. The physician also reported that there was no known changes in the patient's vns therapy prior to the heart issues which would have contributed. The patient has been referred to a local electro physiologist for additional evaluation. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8443672

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« Reply #234 on: May 11, 2019, 04:05:25 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/13/2019
Event Type  Injury   
Event Description
It was reported that upon initial implant, the epileptologist came to the operating room to program tachycardia detection and when do so, the patient¿s heart rate doubled that of baseline. The physician decided to leave detection off until post operative appointment. Sensitivity level was set at 3. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8487574
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dennis100
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« Reply #235 on: May 11, 2019, 04:06:08 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/01/2014
Event Type  Injury   
Event Description
It was reported that the patient was unable to tolerate a vns system diagnostic test and that they experienced tachycardia while under anesthesia when a system diagnostic test was performed. A system diagnostic test requires the generator to provide an output current that was higher than the patient's normal mode output current. Multiple attempts were made to obtain additional information regarding the patient's tachycardia and tolerability issues with system diagnostic tests due to stimulation provided; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8528396
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dennis100
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« Reply #236 on: May 18, 2019, 01:37:24 AM »

tachycardia/
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/10/2017
Event Type  Injury   
Event Description
It was reported that the patient experienced asystole while undergoing a full vns replacement surgery. When the surgeon performed system diagnostics on the generator the first time, the patient's heart beat decreased to 0 beats per minute for a time less than three seconds in duration. The patient went back into sinus rhythm without intervention. The physician reportedly performed diagnostics multiple times after this occurrence, and the patient did not exhibit asystole again in the surgery. The results of the device diagnostic test were within normal limits, and the left vagus nerve was utilized for this implant. The device history records of the implanted generator and lead were reviewed by the manufacturer, and it was determined that all quality tests passed prior to distribution. No additional pertinent information has been received to date.
 
Event Description
The patient¿s treating neurologist reported that the patient has a prior history of cardiac events, including cardiac arrhythmia and tachycardia. The patient did not have known family history of cardiac events. The patient was noted to have several pre-existing medical conditions. The physician indicated that it was possible that the asystole experienced intraoperatively could have been from the vagus nerve stimulation; however, it also could have been due to surgical manipulation. The patient¿s generator was programmed on in an office visit after the surgery, and the arrhythmia did not recur at that time. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6577574
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dennis100
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« Reply #237 on: May 18, 2019, 01:38:11 AM »

Model Number 103
Event Date 01/22/2016
Event Type  Injury   
Event Description
The patient reported that she has facial droop which she resolves with her magnet. The patient also reported that she taped the magnet over the generator to disable device stimulation and she was no longer experiencing tachycardia. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
The physician reported that the facial droop, tachycardia, and voice alteration are not related to vns. The physician reported that voice alteration was not noted. The physician also reported that since the patient relates that when the device is off there are no voice changes, the device was programmed off; however, magnet mode stimulation was left on. The physician indicated it is unclear when and why the patient's complaints originated.
 
Event Description
The patient continues to complain of vocal issues. She indicated that she was seen by an ent. The patient indicated that the ent believed the wire may have gotten tugged during a neck surgery where a steel plate was placed in the patient's neck that may be causing the patient's issues. The patient also reported that she is experiencing vocal dystonia and gastroparesis. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
The physician¿s office indicated that the patient has been treated for dystonia for a while at another clinic and it was not believed to be related to vns. The notes found that the patient was seen on (b)(6) 2016 and the vns was functioning as intended. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5470661
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