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Author Topic: Misc. Respiratory  (Read 277164 times)
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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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