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dennis100
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« Reply #900 on: January 04, 2019, 11:26:40 AM »

Model Number 1000
Device Problem Insufficient Information
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing an increase in seizures which the patient's wife suspected to be due to high vns settings. Another call was received from the wife stating that her husband was recently presenting with some apnea-like symptoms. It was noted that the vns had overall helped the patient with his seizures, but that he has had some seizures and "a recent issue with autostimulation" which may have caused "a little regression". No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8190843
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dennis100
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« Reply #901 on: January 04, 2019, 11:27:46 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/23/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient experienced stridor and cyanosis while using their vns therapy magnet during a 56 minute long episode of continuous seizure activity. After the use of the magnet the patient continued to turn blue every five minutes for the duration of the seizure activity. A second magnet swipe during the seizure also produced temporary cyanosis. It was reported that while the patient typically had stridor/shortness of breath during seizures prior to vns implantation, that the stridor was more noticeable during the magnet swipes. Prior to and following this event, there were no other instances of cyanosis occurring with seizures. The patient had previously encountered minor stridor and shortness of breath events with magnet use during seizures but without complication. The physician decreased the patient's programmed generator settings. It was additionally reported by the patient's caregiver that when the magnet was placed over the device, to inhibit stimulation, the patient's symptoms seemed to resolve. It was reported that the patient's continuous seizure activity was not related to vns. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8175737
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dennis100
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« Reply #902 on: January 11, 2019, 02:55:49 AM »

Model Number 302-20
Event Date 02/01/2011
Event Type  Malfunction   
Event Description
It was initially reported that the pt was complaining of tightening and intermittent pain in her neck and throat into her left ear. The pain was described as burning and jolting and not occurring with stimulation. X-rays were received and reviewed. Generator placement appeared normal and there were no lead discontinuities or sharp angles observed in the visible portions of the lead boy, however, a fracture or micro-fracture cannot be ruled out. Additional info was received indicating that the pt's was also experiencing hoarseness, choking, shooting pain through left ear, and breathing problems. No trauma was suspected, however, it was noted that the pt was moving and had been lifting heavy boxes. Diagnostics could not be performed because the pt could not tolerate the side effects as her output current was less than 1ma. The pt was scheduled for, and underwent a full revision surgery. During the revision surgery, it was noted that the lead insulation appeared to be frayed near the generator. Diagnostics could not be performed prior to the lead explant. The device has since been returned. However, product analysis is not yet complete.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2191333
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dennis100
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« Reply #903 on: January 13, 2019, 04:13:21 AM »

Model Number 103
Event Date 12/28/2010
Event Type  Injury   
Manufacturer Narrative
Describe event or problem; corrected data: additional information indicates that the patient was diagnosed with laryngomalacia in 2013. The initial manufacturer report stated that this issue was followed for many years.
 
Event Description
It was reported that the vns patient was diagnosed with laryngomalacia and had severe obstructive sleep apnea (osa). The neurologist did not comment on the patient¿s laryngomalacia diagnosis as it was made by another physician. The neurologist stated that the patient¿s osa got worse with vns and that it was occurring with stimulation. The neurologist is planning to change the device¿s programmed settings but has not occurred to date. No causal or contributory programming or medication changes preceded the onset of the osa. The patient has a medical history of osa. The patient¿s osa and laryngomalacia were followed for many years. Clinic notes were received for the patient¿s office visit with his neurologist on (b)(6) 2014. The notes indicate that the patient¿s parent was considering having the patient¿s device programmed off to alleviate his osa symptoms. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns is not believed to have caused the onset of laryngomalacia as it is usually a condition that one is born with. The patient was diagnosed with laryngomalacia in 2013 when attending a sleep apnea evaluation. The patient had a diagnostic bronchoscopy exam and was prescribed with reflux medications for laryngomalacia in addition to the medications for sleep apnea.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3725306
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dennis100
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« Reply #904 on: January 22, 2019, 06:23:28 AM »

Neuromodulation. 2012 Nov-Dec;15(6):527-36. doi: 10.1111/j.1525-1403.2012.00454.x. Epub 2012 May 2.

Low voltage vagal nerve stimulation reduces bronchoconstriction in guinea pigs through catecholamine release.

Hoffmann TJ1, Simon BJ, Zhang Y, Emala CW.

Author information

Abstract

OBJECTIVE:
  Electrical stimulation of the vagus nerve at relatively high voltages (e.g., >10 V) can induce bronchoconstriction. However, low voltage (≤2 V) vagus nerve stimulation (VNS) can attenuate histamine-invoked bronchoconstriction. Here, we identify the mechanism for this inhibition.

METHODS:
  In urethanea-nesthetized guinea pigs, bipolar electrodes were attached to both vagus nerves and changes in pulmonary inflation pressure were recorded in response to i.v. histamine and during VNS. The attenuation of the histamine response by low-voltage VNS was then examined in the presence of pharmacologic inhibitors or nerve ligation.

RESULTS:
  Low-voltage VNS attenuated histamine-induced bronchoconstriction (4.4 ± 0.3 vs. 3.2 ± 0.2 cm H(2) O, p < 0.01) and remained effective following administration of a nitric oxide synthase inhibitor, NG-nitro-L-arginine methyl ester, and after sympathetic nerve depletion with guanethidine, but not after the β-adrenoceptor antagonist propranolol. Nerve ligation caudal to the electrodes did not block the inhibition but cephalic nerve ligation did. Low-voltage VNS increased circulating epinephrine and norepinephrine without but not with cephalic nerve ligation.

CONCLUSION:
  These results indicate that low-voltage VNS attenuates histamine-induced bronchoconstriction via activation of afferent nerves, resulting in a systemic increase in catecholamines likely arising from the adrenal medulla.

© 2012 International Neuromodulation Society.

PMID: 22551486 PMCID: PMC3710689 DOI: 10.1111/j.1525-1403.2012.00454.x

[Indexed for MEDLINE] Free PMC Article

https://www.ncbi.nlm.nih.gov/pubmed/22551486
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dennis100
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« Reply #905 on: January 23, 2019, 02:53:35 AM »

Model Number 104
Event Date 12/04/2010
Event Type  Death   
Event Description
It was reported that the vns patient passed away. The cause of death is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Additional information received from the funeral home revealed that the patient passed away at the hospital. The patient died due to cardiorespiratory arrest due to chronic lung disease, encephalopathy, gi shutdown, and complete paralytic ileus. An internal sudep evaluation revealed that the death is unlikely sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3911273
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dennis100
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« Reply #906 on: February 02, 2019, 08:43:56 AM »

Model Number 104
Event Date 04/06/2013
Event Type  Death   
Event Description
It was reported that an autopsy was performed; however, the cause of death was unknown. It was reported that the vns was functioning as intended in (b)(6) 2013 when last checked. The patient was in hospice care at the time of death. It is believed that there is no relationship between the vns and cause of death. The funeral home indicated that the patient was cremated and that the device was most likely explanted; however, there was no indication in the funeral home notes. No additional relevant information has been received to date.
 
Event Description
It was reported that the vns patient passed away. The cause of death and relationship of the death to vns is unknown. An online obituary identified the date of death. It was noted that the patient passed away in hospice care. No additional relevant information has been received to date.
 
Event Description
The death certificate was received which noted the immediate cause of death as chronic restrictive lung disease. Other significant conditions contributing to death, but not resulting in the underlying cause. It was noted that an autopsy was not performed. The manner of death was listed as natural.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4166790
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dennis100
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« Reply #907 on: February 07, 2019, 09:26:21 PM »

Model Number 101
Event Date 05/20/2008
Event Type  Death   
Event Description
It was reported that the vns patient passed away. The cause of death and relationship of the death to vns is unknown. No additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
The funeral home indicated that the cause of death was cardiopulmonary disease and the manner of death was natural. There was no other information available. The physician indicated that the patient was last seen on (b)(6) 2007 and he does not have an opinion on the death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4410520
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dennis100
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« Reply #908 on: February 09, 2019, 03:51:32 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/18/2018
Event Type  Injury   
Event Description
It was reported by the patient that they experienced an allergic reaction following vns surgery and went to the emergency room. The patient indicated that they experienced severe swelling at the chest and neck site as well as difficulty breathing related to their allergic reaction. The physician indicated that the patient had a rash around the surgical sites related to the patient being allergic to the agent used to prepare the surgical site prior to surgery, chlorhexidine prep. The physician indicated that the patient was also allergic to the doxycycline antibiotics consumed. A review of the device history records showed that both the lead and generator were sterilized prior to distribution. No further relevant information has been received to date.
 
Manufacturer Narrative
Device evaluated by mfr? - device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8251305
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dennis100
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« Reply #909 on: February 09, 2019, 03:52:07 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/21/2018
Event Type  Injury   
Event Description
It was reported that the patient was not able to breath following the initial vns implantation surgery. It was stated that the patient¿s vns was programmed on following the implant, which was against the manufacturer's labeling, and that, an hour later, the patient could not breathe. The facility used magnet disablement until the company representative could arrive to disable the vns. It was stated that the physician did not believe the breathing issues were related to the vns, but the pre-existing conditions and the vns surgery. Follow up with the company representative revealed that the breathing issue resolved prior to device disablement, whether by programming or magnet disablement. The medical professional stated that the intervention was both for the patient's comfort and to preclude serious injury. Diagnostics were within normal limits. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8243000
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dennis100
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« Reply #910 on: February 13, 2019, 03:18:31 AM »

Model Number 103
Event Date 04/20/2011
Event Type  Death   
Event Description
It was reported that from our (b)(4) representative that there was a vns patient that died on (b)(6) 2011, 07 weeks after implantation and under vns therapy. The patient who had been implanted vns device on (b)(6) 2011, died on (b)(6) by myocardial infarction. During the explantation procedure, infection and fibrosis were not found. Additional information was received through a death follow-up form indicating that the patient was receiving therapy at the time of death and patient had an autopsy performed. The treating physician indicated that the patient's death was not related to vns. Further information from the autopsy report indicated that the cause of death was due to coagulative necrosis in the heart and pulmonary edema. The treating physician indicated that the patient's cause of death was of sudep and vns device was not related. The explanted generator was received by the manufacturer and underwent analysis. Analysis of the returned generator revealed that there were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the returned lead revealed that other than typical wear and explant related observations, no anomalies were identified within the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2265203
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dennis100
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« Reply #911 on: February 13, 2019, 03:19:18 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/29/2016
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient had passed away due to sudden unexpected death in epilepsy (sudep). It was noted that the patient had gotten into a fight at his group home the day prior. It was reported that an autopsy had been performed which determined that the patient had a pulmonary edema and gliosis of the left temporal lobe. The patient's neurologist did not state that the death was due to vns. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8208812
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dennis100
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« Reply #912 on: February 23, 2019, 02:56:43 AM »

Model Number 304-20
Event Date 09/01/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that she began having problems with vns around (b)(6) 2014. The patient reports sometimes randomly experiencing shocking sensations in her chest. She normally does not feel her stimulations, but when these shocks happen, they would be sharp, intense and take her breath away to where she could not breathe or talk. Then, she would subsequently cough a lot which would last for about 30 seconds. The patient reported that these events would happen randomly, like when she was sitting in a chair. As time has progressed, they have become more frequent. The last time she saw her neurologist, he detected her wheezing so had referred her to an ent get it checked. She went to see an ent, who scoped her. The patient reported she received the diagnosis on (b)(6) 2015 that she has permanent vocal cord paralysis and vocal cord dysfunction. She is currently on an oxygen tank and has to be in a wheelchair when she goes out. The patient reports having no trauma since (b)(6) 2014. The device was still programmed on at that time. The neurologist checked her device on (b)(6) 2015, and no issues were mentioned to the patient. Prior to that time, she saw him about three months ago and the neurologist reportedly made no changes with her vns. The patient reported no contributory trauma. Additional information was received that the patient has a lot of other problems: low oxygen, being obese, elevated blood pressure. All of these are unrelated to vns. The neurologist opted to disable the device for approximately. The neurologist does not believe vns is causing these issues suddenly. He says that it is "highly unlikely that the vns is causing it," but he wants to rule it out and put the patient at ease. Good faith attempts for additional relevant information has been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4657752
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dennis100
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« Reply #913 on: February 27, 2019, 08:58:17 AM »

Model Number 302-20
Event Date 04/13/2010
Event Type  Injury 
Manufacturer Narrative
 
Manufacturer Narrative
The initial report inadvertently reported the incorrect event date. The physician has indicated that the symptoms occurred following implant surgery. The initial report inadvertently did not include the patient's age.

Event Description
Additional information was received from the physician. No x-rays of the patient's vns have been taken. The patient did not experience paresis or difficulty swallowing prior to vns implantation which the physician suggests that there is therefore a relationship of these events to vns implantation. The paresis is reportedly associated with stimulation. However, the dysphagia is apparently not associated with stimulation. The patient has also complained of difficulty breathing when the room temperature is hot or cold since the time of implantation. No patient manipulation or trauma has been reported or has been apparent that may have contributed to the events. No interventions have been taken except examinations by her implant surgeon and by ents.

Event Description
It was reported that the patient had continued neck pain and lead pulling when she turned her head. The patient also had pain/burning in throat and difficulty when swallowing. She said that food seemed to get stuck in her throat. The patient had evaluation by an ent in late 2011 which showed left sided laryngeal paresis and retention of food in the right valleculae with no aspiration. Physician notes that the patient has had improved seizures control with vns, but continued discomfort has distracted from benefit. No patient manipulation of vns has occurred. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2443233
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dennis100
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« Reply #914 on: March 08, 2019, 02:05:17 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/23/2018
Event Type  Injury   
Event Description
Article titled "vagus nerve stimulation for the treatment of refractory epilepsy in the cdkl5 deficiency disorder" was reviewed and multiple adverse events were identified for multiple patients with cdkl5 deficiency disorder (which results in a severe epileptic encephalopathy). Several adverse events were noted in the article and are as follows: 1 patients had the device disabled due to worsening sleep apnea. 2 patients experienced breathing abnormalities after vns implant that resulted in early treatment cessation (likely device disablement). 1 of the 2 patient's also required ventilatory support. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8299135
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dennis100
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« Reply #915 on: March 08, 2019, 02:05:53 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/23/2018
Event Type  Injury   
Event Description
Article titled "vagus nerve stimulation for the treatment of refractory epilepsy in the cdkl5 deficiency disorder" was reviewed and multiple adverse events were identified for multiple patients with cdkl5 deficiency disorder (which results in a severe epileptic encephalopathy). The following adverse event was reported within the article: 1 patient was admitted to the icu with ventilation support due to severe vocal cord paralysis. Other adverse events within the article are reported in mfr. # 1644487-2019-00211. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8299302
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dennis100
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« Reply #916 on: March 08, 2019, 02:06:26 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/24/2019
Event Type  Injury   
Event Description
During generator and lead replacement surgery, it was reported that after diagnostics were performed it appeared as if the patient had stopped breathing. The patient would start breathing again after the diagnostic test was completed. The patient's device was programmed to zero for a long period of time prior to the replacement surgery. It was reported that the patient stopped breathing during every system diagnostic and that the anesthesia department noticed this during surgery. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8340875
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dennis100
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« Reply #917 on: March 12, 2019, 03:53:11 AM »

Model Number 103
Device Problem Insufficient Information
Event Date 10/07/2015
Event Type  Injury   
Event Description
A battery life calculation was performed which showed the generator had approximately 2. 1 years remaining until near end of service (neos) = yes, indicating the generator was still providing therapy at the time the patient was admitted to the hospital. The hospital staff who worked with the patient was contacted, but they were unable to remember any details regarding the patient and they were unable to provide any information. Additionally, the current following physician is unknown.
 
Event Description
It was reported the patient was admitted to the hospital with an increase in seizures and respiratory depression. It was noted the patient was put on a ventilator. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5202673
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dennis100
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« Reply #918 on: March 30, 2019, 02:37:29 AM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/28/2017
Event Type  Injury   
Event Description
It was reported that a patient began experiencing an inspiratory stridor after vns implant surgery that did not resolve after about two weeks. The patient's physician ordered chest x-rays and opted to leave the device programmed off due to the event. The patient was seen by an ent who stated that there was bruising on the left vagus nerve and that the patient had paresis of the left vocal cord. The patient's physician believed the bruising of the nerve and the vocal cord paresis were both related to surgery due to the manipulation of the vagus nerve that took place during implant. A review of the manufacturing records for the implanted lead confirmed it had passed all quality inspections prior to release for distribution and was sterilized per specifications prior to release for distribution. The surgeon also indicated that the post-op impedance values were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6535105
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« Reply #919 on: April 02, 2019, 01:47:20 AM »

Model Number 106
Event Date 04/23/2016
Event Type  Death   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had passed away. The cause of death is unknown. A search for an obituary determined the date of death. The patient's vns system was reportedly explanted post-mortem, but was not available for return. Based on the limited available information about the patient's death to the manufacturer, an internal classification has determined that the death may be possible sudep. However, the patient's death is suspected to be sudep by the involved medical professionals based on circumstances unknown to the manufacturer. The conclusion of their assessment has not been conveyed to date.
 
Event Description
The explanted generator and lead were received by the manufacturer on (b)(6) 2016 for product analysis. Product analysis was completed on the returned lead portion on (b)(6) 2016. A section of the lead assembly was returned for analysis in one piece with the lead connector portion still attached to the pulse generator. Initial testing on the generator as-received showed the lead pin had electrical continuity with the generator. The lead's electrodes were not returned for evaluation. Other than the typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis was completed on the returned generator on (b)(6) 2016. Visual examination showed only explant-related observations; no surface abnormalities were noted on this device. The device output signal was monitored for more than 24-hrs 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. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 3. 030 volts during the relevant portion of the final electrical test and showed an ifi=no condition. There were no performance or any other type of adverse condition found with the pulse generator.
 
Event Description
The patient's mother reported that the vns messed up the patient¿s throat to where they could not swallow and struggled to breath. By the time these harmful effects were found, it was too late to save the patient. Additional information was received from the neurologist that the patient had catastrophic neurological disorder that couldn't be characterized. Soon before the patient¿s passing, the patient presented with fever, coughing, difficulty swallowing, as well as an undefined genetic disorder, but there was said to be no relation to the vns device. The patient was seen by a nutritionist around the same time who noticed the patient coughing and gagging, and recommended that the patient should not eat anything by mouth, and therefore the patient was started using tube feeds. A gastrostomy tube was placed about a month prior to the patient's passing. The neurologist mentioned that the vns was working correctly the last time he saw the patient. The doctor does not believe there to have been any malfunction with the vns device. He also stated that the patient had swallowing difficulty since birth and does not believe the swallowing issues or difficulty breathing issues to be due to the vns device, as the patient never presented with these issues in relation to the device. The doctor stated that it was noted that the patient passed away in her sleep. The doctor stated he did not know for sure, but did not believe that the patient's passing was related to the vns device. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5670049
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« Reply #920 on: April 02, 2019, 01:48:30 AM »

Model Number 102
Event Date 04/01/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2016 it was reported that the patient was admitted to the hospital for a pleural effusion, tube, and antibiotic. A culture showed a staph infection related to a foreign body. Currently the physician believes that this is associated with vns as it is in the left lung. The patient is being considered for an explant surgery. The patient's generator and lead were both explanted on (b)(6) 2016. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead and generator were both sterilized prior to shipping.
 
Event Description
The treating vns physician reported that she was unsure of the relationship of the infection to vns. The vns devices were removed prophylactically due to concern of the infection spreading to the vns devices.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5668514
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« Reply #921 on: April 03, 2019, 01:34:03 AM »

Model Number 103
Event Date 04/09/2013
Event Type  Death   
Event Description
It was reported by a physician's office that a vns patient was deceased. An obituary search identified the patient died at the hospital on (b)(6) 2013. Additional relevant information has not been received to-date.
 
Event Description
Follow-up to the treating physician indicated they did not know the cause of death, but stated it was not related to vns. Follow-up to the hospital where the patient died revealed that the cause of death was acute respiratory arrest, and pneumonia.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5760018
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« Reply #922 on: April 05, 2019, 10:24:35 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/04/2019
Event Type  Injury   
Event Description
It was reported that the patient consulted with a surgeon for removal of the vns due to breathing issues at night and vomiting. The patient now has to use a cpap. It was reported that the patient¿s pcp suspected the issues may be related to vns, but was unsure since the patient¿s lab results were normal. The patient reported having a decrease in seizures from vns therapy and has been working with a neurologist to adjust therapy. Clinical notes were later received which reported the patient experienced the stomach flu and had several vns adjustments by the neurologist. 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=8464223
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dennis100
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« Reply #923 on: April 05, 2019, 10:25:22 PM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/18/2005
Event Type  Injury   
Event Description
Article titled "vagus nerve stimulation in children less than 5 years old" was reviewed and an adverse events was identified for one of the patients studied within the cohort. It was reported that one patient has had the battery pack/generator replaced. This patient experienced episodes of transient oxygen desaturation after the battery replacement; thus, they were admitted for observation but were discharged after 24 h. It was noted that no cause for the incident was found. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8444669
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dennis100
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« Reply #924 on: April 05, 2019, 10:26:16 PM »

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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dennis100
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« Reply #925 on: April 05, 2019, 10:27:30 PM »

Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/21/2002
Event Type  Malfunction   
Event Description
It was reported by a patient in medwatch mw5083309 that following their vns implant, they lost the use of her vocal cords for over eight months, and had partially lost the use of her vocal cords for many years. This is reported in mfr report #1644487-2019-00429. The patient also reported that their oxygen levels dropped and remained very low. The patient has remained on oxygen since then. The patient also reported that they have been depressed following the implant. They stated that it has been a very serious depression. This is reported in this report, mfr report #1644487-2019-00428. Programming history was reviewed for the patient. The patient¿s device was disabled. No anomalies were seen. Device history records were reviewed for the devices. The devices passed all specifications prior to distribution. Attempts for more information have not been successful to date. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8401427
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dennis100
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« Reply #926 on: April 06, 2019, 02:41:37 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/15/2019
Event Type  Injury   
Event Description
It was reported that the patient has had pain, stridor, and the feeling of nerve pulling. The patient had lost sixty pounds. The patient was referred for surgery to replace and reposition the generator. Programming history was reviewed for the patient and was only available on the date of implant. No anomalies were seen. Surgery is likely but has not occurred to date. There is no additional or relevant information received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8412313
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dennis100
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« Reply #927 on: April 08, 2019, 02:54:04 AM »

Model Number 300-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/21/2002
Event Type  Injury   
Event Description
It was reported by a patient in medwatch mw5083309 that following their vns implant, they lost the use of her vocal cords for over eight months, and had partially lost the use of her vocal cords for many years. This is reported in this report. The patient also reported that their oxygen levels dropped and remained very low. The patient has remained on oxygen since then. The patient also reported that they have been depressed following the implant. They stated that it has been a very serious depression. This is reported in mfr report #1644487-2019-00428. Device history records were reviewed for the devices. The devices passed all specifications prior to distribution. Attempts for more information have not been successful to date. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8401443
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dennis100
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« Reply #928 on: April 24, 2019, 03:03:24 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/02/2017
Event Type  Injury   
Event Description
It was reported by a physician on (b)(6) 2017 that a patient¿s device was ¿poking out¿ and the patient presented to the er the week before. He reviewed the patient's device via ultrasound and discovered that the generator had been flipping and had migrated. The surgeon stated that he always sutures the generator in place but that he would have to perform a revision to re-suture the generator in place. The patient then stated she had a lot of chest pain and was going for revision of her pocket because her surgeon told her that it was moving too much. Surgery to secure the generator occurred. The patient later provided on (b)(6) 2017 that the generator was flipping over from 4 months prior, and was moving to her arm. The patient reported this caused tremendous pain, but it was flipped surgically, and re-stitched. Additional relevant information has not been received to-date.
 
Event Description
The patient then later provided that before the repositioning surgery it felt like she was being strangled over 2-3 minutes apart and she was in excruciating pain. The patient repeated that she was in pain from the generator migration and that when trying to use her arm the generator would turn over 180 degrees.
 
Event Description
Follow-up from the patient was received providing that he says she had her device adjusted about a year ago and stated the physician had to turn it down because it was too high, and increased her seizure medications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6960601
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dennis100
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« Reply #929 on: April 24, 2019, 03:04:30 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/09/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was sitting on his couch when he suddenly began feeling vns stimulation. He began to experience a choking sensation along with painful stimulation in his neck. The patient then presented to an er where it was noted that the normal mode stimulation had been programmed off several months earlier due to painful stimulation however the magnet mode was left on at that time. Diagnostic testing was performed in the er by a company representative and it resulted within normal limits. The magnet mode stimulation was then programmed off at the request of the physician. The patient was later evaluated by the physician who expressed concern about the vns leads however there were no impedance issues noted. The physician ordered chest x-rays for the patient however these images have not been reviewed by the manufacturer to date. The physician also noted that there had not been any medication changes in over a year, so he was not concerned that medication was contributing to the symptoms. The patient was then referred for a generator replacement due these symptoms. Further follow-up found that the physician believed that the symptoms were serious and needed to be addressed; which is why the patient was being referred for a replacement. No surgical interventions are known to have occurred to date.
 
Manufacturer Narrative
Initial report had inadvertently not selected required intervention to prevent permanent impairment/damage.
 
Event Description
It was reported that the patient's generator replacement surgery was completed. The company representative later reported that the patient had past reports of stridor, which were likely related to the settings and stimulation. She stated that the patient initially did not want to replace the device due to this, but the vns helped the patient. The generator has not been received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6455069
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