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Author Topic: Misc. Respiratory  (Read 262996 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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