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dennis100
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« on: April 29, 2016, 02:49:38 AM »

Model Number 102
Event Date 08/11/2008
Event Type Injury
Event Description
Reporter indicated a vns therapy pt is experienced an "asthma attack - extreme shortness of breath. " it was stated it was a single episode that was probably related to vns therapy stimulation. The event resolved without intervention. Good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1155535
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dennis100
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« Reply #1 on: April 29, 2016, 02:50:25 AM »

Model Number 102
Event Date 09/18/2008
Event Type Injury
Event Description
Rptr indicated a vns therapy pt is being referred to surgeon for explant of the device. The reason for the explant is exacerbation of asthma and painful stimulation. Good faith attempts to obtain add'l info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1202921
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dennis100
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« Reply #2 on: April 29, 2016, 02:51:46 AM »

Model Number 102
Event Date 08/01/2008
Event Type Injury
Manufacturer Narrative
Date of event; corrected data: additional information indicates that the dyspnea was first observed on (b)(6) 2008.

Event Description
It was reported that a vns patient had experienced two episodes of respiratory stridor and shortness of breath. The initial episode was reported to be continuous in frequency and moderate in severity. The patient's treating physician ruled the event to be possibly related to stimulation, unlikely related to implantation and indicated that no interventions taken. The second episode was reported to be continuous in frequency and severe. The patient's treating physician ruled the event to be possibly related to stimulation, unlikely related to implantation and indicated that this episode was not a serious adverse event. The physician also indicated that the following interventions were taken: parameter changes were made, magnet used to disable generator, medication was added and that the patient was admitted to the emergency room and had an ent evaluation.

Event Description
Additional information was received indicating that the vns patient¿s dyspnea was first observed on (b)(6) 2008. The patient¿s device was disabled on (b)(6) 2010 as the patient was unable to tolerate the dyspnea and stridor which were believed to be related to vns stimulation. The patient¿s respiratory issues improved following device disablement. The patient¿s device was programmed back on in 2009. Although the patient was given medications, the shortness of breath continued along with an onset of asthma. The asthma was believed to be related to vns stimulation as it resolved when the device was disabled. During an office visit on (b)(6) 2011, the physician elected to keep the device disabled and pursue explant in the future. The patient underwent surgery on (b)(6) 2013. The explanted device has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1215357
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dennis100
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« Reply #3 on: June 21, 2018, 12:56:24 AM »

Model Number 302-20
Event Date 01/01/2011
Event Type  Injury   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies.
 
Manufacturer Narrative

Event Description
Additional information was obtained from the surgeon. He indicated that the patient was a non-responder to vns and he was unsure if the migration was occurring. There was no suspected manipulation or trauma. The physician indicated that the patient had extreme difficulty with her asthma when the device would stimulate but also stated that the surgery was performed for patient comfort.
 
Event Description
The patient reported that the lead would migrate and "block her throat" during her asthma attacks. Per the patient, this was preventing her from breathing. The patient did not know when the event started. At the time of this report, the patient also indicated that she did not experience efficacy from the device. The patient's vns system has since been explanted and the lead and generator have been returned to the manufacturer for product analysis. Analysis is not yet complete. It is unclear at this time, if the explant was performed for the reported migration or lack or efficacy. Attempts for additional information are underway.
 
Event Description
Product analysis on the generator was completed on (b)(4) 2012. In the (b)(4) lab, the device output signal was monitored for more than 24-hrs, while the generator was placed 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 for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis on the explanted lead was also completed. An analysis was performed on the returned lead portion. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. A puncture mark was observed on the outer silicone tubing. The mark penetrated the outer insulation and one inner silicone tubing. The quadfilar coil did not appear to be damaged. Slice marks were observed on the outer silicone tubing. The marks penetrated the outer and one inner silicone tubing and the quadfilar coil appeared to be kinked. The puncture and slices appeared to be made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device. Attempts for additional information have remained unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2351148
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dennis100
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« Reply #4 on: June 21, 2018, 12:57:05 AM »

Model Number 102
Event Date 02/01/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a nurse that a vns patient experiences vns related asthma. The patient claimed to not have seen her vns physician since 2009 and was warned prior to implant that this could possibly be a side effect from therapy. At the moment, the patient is looking for another physician. Additional information was received from the previous treating nurse indicating the patient suffers from psychological problems. The respiratory problems referred to by the patient have been looked at by a lung specialist and many settings were tried out in order to accommodate the patient, but patient remained unhappy, claiming depression when generator was turned off and asthma when turned on.
 
Event Description
Moreover, additional information from the treating physician indicated the patient was psychologically unstable prior to vns. After vns was implanted, the patient would have periods of depression which nonetheless were higher than pre-vns baseline.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2467534
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dennis100
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« Reply #5 on: June 21, 2018, 12:57:42 AM »

Model Number 102R
Event Date 06/30/2011
Event Type  Injury   
Event Description
Additional information was received as an implant card containing generator product information.
 
Event Description
It was reported via clinic notes received that the pt has a history of obstructive sleep apnea and uses a cpap. The pt was also noted as having asthma. The relationship of these events to vns is unk. Diagnostics taken on (b)(6) 2011, indicate normal device function. Attempts for additional info have been unsuccessful to date.
 
Event Description
Additional information was received from the physician indicating that the patient has a long history of obstructive sleep apnea. It was originally believed to be related to the patient's seizure behavior; however, this began to be questioned on (b)(6) 2002. The relationship of the sleep apnea to vns has not been documented. The cpap use was noted as improving the sleep apnea. No changes to vns settings have been made as intervention to the sleep apnea. The patient was noted as having a sleep study done on (b)(6) 1999 secondary to large adenoids.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2338065
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dennis100
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« Reply #6 on: June 21, 2018, 12:58:19 AM »

Model Number 102
Event Date 08/04/2006
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient passed away on (b)(6) 2016. She was found deceased in her home. The physician reported that the patient had cps and gtc seizures along with morbid obesity and depression. The patient was presumably seizure free, according to the physician's report. An autopsy was not performed, but the generator and lead were explanted and discarded. The patient's last visit to her physician was on (b)(6) 2006, and the patient was receiving vns therapy at the time of death to the physician's knowledge. The patient was on topimate and lamotrigine at the time of death. The relationship of the death and vns was unknown since the cause of death was unknown, but the physician did not attribute the death to vns. Additional information was received from the national death index. The cause of death was: major cardiovascular disease, generalized and unspecified atherosclerosis, other obesity, unspecified depressive episode, unspecified epilepsy, unspecified asthma, and unspecified arthrosis. A sudep (sudden unexpected death in epilepsy patients) evaluation was performed based on information from the national death index, and the death was determined to be probable sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5983626
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dennis100
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« Reply #7 on: June 21, 2018, 12:59:34 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 11/12/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was having issues with the vns. It was stated that the patient was experiencing asthma, tightness, and a tight throat while attempting to eat during stimulation on times. The vns was previously disabled due to these events, but then was programmed back on. Follow up with the physician's office revealed that the patient stated that she previously had asthma when she was younger and was diagnosed with mild seasonal asthma, but that it had increased. It was unclear if the increase coincided with the implantation of the vns. It was reported that the patient was on oxygen and had a pre-existing pulmonary dysfunction and that the patient's test results were very abnormal. It was stated that the patient may have chronic obstructive pulmonary disease, or copd. The patient stated that she had difficulty swallowing with vns stimulation due to the tightness, but the patient also experienced difficulty breathing through her nose previously, which was why the patient was on oxygen. The patient stated that she was on oxygen immediately following the vns implantation surgery due the pulse ox readings being so bad. The patient was forced to discontinue oxygen use previously due to insurance issues, but upon recently getting back on oxygen, stated that she felt better. The patient had previously been on steroid inhalers and then an asthma disk. The patient reported that she sometimes anticipated the stimulation, would tense up, and then have difficulty swallowing or drinking. However, it was stated that when she was sitting, the patient was fine and did not even perceive stimulation. The patient felt that she anticipated the previous vns on time and that it was too long. The patient was referred for a swallowing study and would also have a ct scan. The patient's stimulation on and off times were reduced to shorter periods and the output currents were increased. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7299811
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dennis100
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« Reply #8 on: June 21, 2018, 01:00:16 AM »

Model Number 103
Event Date 06/06/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received that the relationship of the oxygen saturation drop at night to vns is unknown. The physician coordinated a dosage of risperdal and potassium bromide on (b)(6) 2013. During follow-up, the oxygen saturation was 90%. The patient does have a history of asthma.
 
Event Description
It was initially reported that the patient¿s oxygen saturation decrease during sleep to 83-84%. The casual relationship between vns stimulation unknown. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3637222
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dennis100
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« Reply #9 on: June 21, 2018, 01:00:54 AM »

Model Number 103
Event Date 08/04/2014
Event Type  Death   
Event Description
Additional information was received when the physician reported that the patient¿s cause of death was chronic obstructive pulmonary disease (copd). The patient¿s concurrent illnesses at the time of death were noted to be emphysema, copd, asthma, depression, and anxiety. The physician does not believe that the patient¿s death was related to the vns. The patient was noted to be at end stage lung disease and was on oxygen.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient passed away. An online obituary identified that the patient passed away at home. The cause of death and relationship of the death to vns are unknown. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4245861
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dennis100
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« Reply #10 on: June 21, 2018, 01:01:34 AM »

Event Date 07/23/2008
Event Type  Injury   
Event Description
Vagus nerve stimulator implanted: 2006, turned on: the following month, explanted the following month: coil/electrodes not removed. Er visit: infection at incision site on my neck: a month after the original month. I told the nurse practitioner that something felt wrong with the lead in my neck. It felt like something had moved, it just didn't fell right. The first time i told her was in five months later, i believe. Er visit: nerve stimulator malfunction: the following month, no one there knew what to do, taped my magnet on and went home. Had x-ray, that was sent to cyberonics i had it turned off for at least a month. I was so afraid of turning it back on. Once i had it turned back on, i started having migraines almost everyday. I put up with it for several more months, then i asked for it to be turned off, and i asked about getting it removed. I believe it was turned off in 2007. After it was turned off, i started getting severe cramps in my neck. I had an appointment with dr at medical center in 2008 to discuss removal of my vagus nerve stimulator. He said the surgery was too dangerous, there could be scar tissue entangled around the carotid artery and or jugular vein. Surgery could result in a stroke or even death. He also said surgeons do not like to remove items implanted by other surgeons, because he doesn't know how it was put in. He suggested i do some stretching exercises. He said a muscle relaxer might help, but would not be good for my bi-polar. He said if it were him, he would leave it in until i couldn't bear the pain any longer. He also said, he thought there may be something else going on, the leads may not be causing the spasms. I told him that if i were not able to stretch my neck and get the cramping to stop, i would have to go to the er. I am afraid of that happening more, so now after what he has said about the surgery. I had to go to the er after an adjustment caused severe electrical shocks. The doctor in the er didn't have a clue what to do, and had never heard of the vns. They told me to go to the doctor that implanted it. That doctor is in missouri! the cramps/spasms are becoming more frequent. What happens if i do have to go to the er, are they going to have a doctor-neurosurgeon- there to do emergency surgery! my asthma is worse. I have to use inhaler every night. As soon as i lay down, i start to wheeze and cough. I wake up coughing and have to use the inhaler again. I don't need the inhaler during the day? - my abdomen has sharp pains when i turn over during the night. -the abdomen pain comes and goes - happened during the day only a couple of times - i am having terrible sneezing attacks that last 12-15 hours per day. But, if i sit completely still, i will not sneeze. These attacks are about every other week, or more. They completely wear me out! i have not felt well for a couple of months, fatigue, nausea and lots of bouts of diarrhea. I have pain - comes and goes - in both my breasts, like electrical shocks from the top all the way to my nipples. They are sore to touch, comes and goes. May be: the vagus nerve stimulator has aggravated my vagus nerve - and who knows what else - and is causing some of the problems i listed above. I called the surgeon in missouri - i live in nc now - and the nurse told me the doctor said the leads should not be removed. She said the doctor said surgery would cause more scar tissue. I was never told that the complete device couldn't be removed. Had to remove device approx four months later. Dates of use: 2006 -- 2007. Diagnosis or reason for use: depression.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1100549
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dennis100
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« Reply #11 on: June 21, 2018, 01:02:12 AM »

Model Number 102
Event Date 06/03/2010
Event Type  Death   
Event Description
It was reported by a psychiatrist that a vns pt suffering from depression passed away on (b)(6) 2010. Good faith attempts to obtain more info regarding the relationship of pt's death to vns from the treating physician have been unsuccessful to date. Death certificate was obtained from the corresponding county and the manner of her death was ruled 'natural. ' it also stated that no autopsy was performed on the pt and pt's cause of death was cardiac arrest / sudden death, pulmonary embolism, and asthma.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2007261
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dennis100
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« Reply #12 on: June 21, 2018, 01:02:51 AM »

Model Number 102
Event Date 12/13/2012
Event Type  Injury   
Event Description
Reporter indicated that during a ventral hernia repair surgery, a vns patient had an episode of bradycardia. The patient did not have a history of cardiac events, but the patient's father did have a history of cardiac events. The patient has pre-existing medical conditions of hypertension, depression, asthma, gerd, and tmj. The arrhythmia experienced was bradycardia; normal heart rate was 72, during event it was 39. Preoperative bp was 128/74, bp during event was 56/27 at the lowest. The vns generator was programmed on for the surgery. Interventions taken for the intraoperative bradycardia event were done to preclude a serious injury. The bradycardia has not recurred. Follow up with the reporter revealed '"pt presented for ventral hernia repair on (b)(6) 2012. Pt had eventful preoperative course, and no issues with induction of anesthesia. 1 hour into the case, during extensive lysis of adhesions in the abdomen [using electrocautery], the patient became profoundly bradycardic and hypotensive. Pt's anesthetic was decreased and he was given 100% o2, phenylephrine 600 mcg total, glycopyrrolate 0. 1 mg, atropine 0. 8 mg, calcium 0. 5 mg, magnesium 1 gm, and a total of 1. 7 mg epinephrine over the course of about 30 minutes during the severe bradycardia. A magnet was also placed over the [vns] device intraoperatively and transcutaneous pacing was used during the event. The case was aborted and the patient was subsequently extubated and taken to pacu and then the icu for overnight monitoring. He experienced no abnormal sequelae and returned several weeks later for the procedure without complication. " it was felt the combination of the extensive electrocautery used and the vns stimulation may have caused the bradycardia event per the reporter.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3023649
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dennis100
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« Reply #13 on: June 21, 2018, 01:04:33 AM »

Model Number 102
Event Date 05/04/2011
Event Type  Injury   
Event Description
Additional information was received on (b)(6) 2011 when the explanted generator was returned for product analysis that was completed on (b)(6) 2011. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed 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 for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Additional information was received on (b)(6) 2011 when the implant card was received from the hospital reporting that the patient's lead impedance after surgery was within normal limits.
 
Event Description
Additional information was received on (b)(6) 2011 when the implant card was received from the hospital reporting that the patient's lead impedance after surgery was within normal limits.
 
Manufacturer Narrative

Event Description
On (b)(6) 2011, clinic notes from a vns treating physician were received through case management. Review of the clinic notes dated (b)(6) 2011 revealed that the patient was experiencing pain in their chest with stimulation. The patient said the pain is sharp and is at the incision location of the generator site. The patient was also reported to be experiencing sleep apnea. The patient was recently evaluated by an ear, nose, and throat physician who discovered that the patient has paralysis of the left vocal cord in the median position which is causing the patient dyspnea and coughing. The patient says that the vns does help with seizures and that if the vns is off she will have grand mal seizures. A 14-system review of the patient's systems was done by the physician and the patient was found to have asthma. The patient's settings were output=2. 75ma/frequency=30hz/pulse width=130usec/on time=30sec/off time=1. 8min/magnet output=3ma/magnet on time=60sec/magnet pulse width=130usec. The physician reported that if the patient's symptoms persist, it may be necessary to explore and possibly replace the generator as she gets benefit from a functioning system. Clinic notes dated (b)(6) 2011 report that the patient has had an increase in seizure frequency over the past few months. The patient has also noticed an increased pain in her left chest in the area of the generator pocket. Diagnostics were performed which revealed no malfunction; specifics were not provided. The physician reported that given the patient's pain in her chest, as well as decreased efficacy within the past 3 months, he is referring the patient for prophylactic battery replacement. Additional clinic notes were received from the physician dated (b)(6) 2011 which revealed that the patient was having an increase in spells. The patient went to the epilepsy monitoring unit and these were non-epileptic. The patient also feels that her asthma has worsened. The patient's settings were output=2. 75ma/frequency=30hz/pulse width=130usec/on time=30sec/off time=1. 8min/magnet output=3ma/magnet on time=60sec/magnet pulse width=130usec. A battery life calculation was performed with the patient's programming history and it revealed negative years until eri = yes. The patient went for battery replacement surgery on (b)(6) 2011. The manufacture's consultant reported that she has the explanted generator and will be sending it back for product analysis but it has not yet been received. When additional information has been received, it will be reported.
 
Manufacturer Narrative
The aware date as well as the date that the implant card was received should have been listed as (b)(6) 2011.
 
Event Description
Additional information was received on (b)(6) 2011 when the implant card was received from the hospital reporting that the patient's lead impedance after surgery was within normal limits. The manufacturer's consultant reported that she made good faith attempts to obtain additional information from the physician concerning the patient's adverse events. The physician reported that the patient is doing well after the generator replacement and that all the patient's issues have resolved except for her pre-existing conditions.
 
Manufacturer Narrative
(b)(6). The aware date as well as the date that the implant card was received should have been listed as (b)(6) 2011.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2212668
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dennis100
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« Reply #14 on: June 21, 2018, 01:05:15 AM »

Model Number 102R
Event Date 02/01/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient was experiencing hoarseness, shortness of breath, and throat pain. The patient¿s asthma had exacerbated at the time. The patient was given steroids and an inhaler and the symptoms resolved. The patient later reported experiencing pain at the lead site and pain from laughing and coughing. The patient also reported discomfort at night and began snoring. The patient and patient's mother reported hearing and engine-like sound coming from the patient's device at night. The patient refused to have her device settings adjusted but noted that she was not using her magnet due to discomfort. Further follow-up revealed that x-rays were later taken and confirmed proper placement of the generator and lead; however, they showed chest wall infection with consolidation of the left lower lobe that was affecting her breathing. The patient is expected to receive antibiotics and a follow-up x-ray. Attempts for additional relevant information were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3800594
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« Reply #15 on: June 21, 2018, 01:05:53 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 08/01/2015
Event Type  Injury   
Event Description
(b)(6) 2016 notes state that the patient is here to have the vns settings decreased. Since having her duty cycle increased in august, she has been experiencing problems related to her vns. She has been wheezing, has shortness of breath, and cannot tolerate walking short distances or going up a flight of stairs. She saw an ent and was told she has vocal cord dysfunction. The md decreased duty cycle from 35% to 29%. (b)(6) 2016 -patient left to do stairs and walk briskly; came back and is still having problems with wheezing and shortness of breath. Turned device off and repeated, wheezing and shortness of breath gone totally. She feels much better. But with device off feels like she is having muscle spasms near vagus nerve, could feel the quiver of left neck which also affected her speech. Device was then decreased to 0. 5 ma then back to 1. 5 ma. So patient was set back to 1. 5 ma and will be seen in a few weeks to reduce if necessary. (b)(6) 2016 notes state the home pulmonary and ent specialists state that the wheezing while exercising is related to vns. When the vns was stopped she was able to exercise quite well without difficulties. They state that may indicate significant airway obstruction related to vagus nerve stimulation. Notes state they will get her down to 1 ma and cycle 30 sec on and 5 min off and see if that becomes more manageable in terms of her breathing.
 
Event Description
It was reported that the patient saw a local ent and the neurologists have yet to see the patient in the office. She was not complaining at all when they previously saw her. Further follow-up showed that the patient has been wheezing, having shortness of breath, and difficulty walking short distances. She thought her asthma was flaring up so she saw her primary physician. He noticed that the wheezing was coming from her throat. She was sent to ent and had further testing done. She was told she has vocal cord dysfunction most likely from the vns.
 
Event Description
It was reported on (b)(6) 2015 that the patient has reported left vocal cord dysfunction. The onset of the event is unknown. The patient has consulted with an ent surgeon on whether or not any intervention needs to be taken.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5341090
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« Reply #16 on: June 21, 2018, 01:06:39 AM »

Model Number 300-20
Event Date 04/24/2001
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient had generator and lead explant surgery on (b)(6) 2014 to undergo other indication treatment. The explanted products were discarded.
 
Event Description
Clinic notes dated (b)(6) 2014 reported that by the patient¿s report, she had occasions of unilateral vocal cord paralysis following vns procedure. Subsequently, she seemed to stabilized after undergoing a vocal fold injection procedure. The vocal folds were evaluated to be bilaterally mobile with exhibition of mild edema. The patient presented with report of progressively worsening breathing difficulties. The vns generator was programmed off to 0ma which the physician evaluated may provide some immediate relief with respect to the breathing issues. It was previously reported that the patient had vns programming changes made due to tolerability issues including with subtle hoarseness during stimulation but was tolerated. A note from (b)(6) 2007 indicated the patient had increasing breathing problems and was unknown if related to a recent increase in settings. Later in (b)(6) 2008, the patient felt the breathing issues were related to vns and as a result did not want to increased settings. In (b)(6) 2008, the treating physician indicated the patient¿s asthma was worse and unknown if related to vns at that time. The patient's previously treating physician who managed the vns treatment has retired.
 
Event Description
Operative notes from explant surgery on (b)(6) 2014 were received and indicated that the pre- and post-operative diagnoses was dyspnea and chronic laryngitis. The indication for procedure detailed that the patient developed chronic laryngitis with symptoms of constriction of the larynx after vns implant, which may be related to the vagal nerve stimulator lead. The surgeon noted that they had concerns that the vagal nerve stimulator may be ¿inappropriately activating the recurrent laryngeal nerve. Because of this, the device will need to be removed. " the generator (including surrounding scar tissue) and majority of lead were explanted; all of the electrodes were not explanted, ¿recognizing the risk of additional dissection was certainly not warranted by any benefit of harvesting additional nerve lead wire. ¿.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4102898
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dennis100
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« Reply #17 on: June 21, 2018, 01:07:15 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2316734
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dennis100
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« Reply #18 on: June 21, 2018, 01:08:10 AM »

Model Number 102
Event Date 06/13/2014
Event Type  Injury   
Event Description
It was reported that the vns patient¿s device was programmed back on during an office visit on (b)(6) 2014 and began affecting the patient¿s heart rate. The patient also had asthma and choking sensations. The patient¿s device was disabled on (b)(6) 2014. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3927782
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dennis100
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« Reply #19 on: September 09, 2018, 01:24:55 AM »

Event Date 08/29/2011
Event Type  Injury   
Event Description
Reporter indicated he would not provide any information to the manufacturer regarding any patient events.
 
Event Description
Reporter indicated a vns patient was hospitalized due to difficulty breathing with stridor, asthma, and vocal cord paralysis. The vns was disabled and the patient improved. The patient is being treated with medication. The patient had recently had the vns generator replaced on (b)(6) 2011. The patient was originally implanted with vns on (b)(6) 2007. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2265822
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dennis100
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« Reply #20 on: September 16, 2018, 03:29:22 AM »

Model Number 102
Event Date 11/01/2011
Event Type  Injury   
Manufacturer Narrative
Date received by manufacturer (mm/dd/yyyy), corrected data: initial report selected (b)(6) 2011 as the aware date; however the aware date is (b)(6) 2011.
 
Event Description
It was reported that a patient was hospitalized due to issues with asthma on (b)(6) 2011 and previously, in (b)(6) 2011. Per the patient, the device had previously been programmed off but when it was programmed back on, the patient began to have issues with asthma. Follow up with the patient's treating physician revealed that the device stimulation is probably a contributing the asthma as it appears to come and go with the device on and off; however, when on, the asthma is not limited to stimulation on times only. The patient does have a medical history of asthma prior to being implanted with vns. There were no causal or contributory medication or programming changes prior to the onset of the asthma. The device was programmed off on (b)(6) 2011 per the physician when the patient was in the emergency room due to asthma. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2379152
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dennis100
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« Reply #21 on: September 23, 2018, 03:08:03 AM »

Model Number 304-20
Event Date 03/16/2011
Event Type  No Answer Provided   
Manufacturer Narrative
The event of the patient's worsening asthma was inadvertently omitted from the initial mdr report.
 
Event Description
Clinic notes from the new treating physician were received indicating surgery to replace the vns generator and possibly the lead may be done in order to relieve the patient's symptoms of voice alteration, dyspnea and painful stimulation. It is suspected the lead placement may be the cause of the patient's adverse events. A surgery date has not been set. Attempts for additional information are in progress.
 
Event Description
Rptr indicated that since she was implanted with the vns in (b)(6) 2011, she was experiencing vocal cord paralysis when the vns would stimulate. The rptr stated she had a bronchoscopy performed and it was confirmed the left vocal cord had "some sort of paralysis" during vns stimulation. The patient did not wish to have the vns disabled by her treating neurologist. Mfr follow up with the treating neurologist's office revealed the neurologist was aware of the pt's reported vocal cord paralysis, but that the pt had been released from their practice as of (b)(4) 2011 and they had no info. The office did state that the pt was seen on (b)(6) 2011 and the vns was working properly at that time. In addition, the pt refused to have the vns disabled. It is unk which physician the pt may be seeing at present.
 
Event Description
Reporter indicated that in addition to the vocal cord paralysis, she has also experienced worsening asthma since the vns was implanted.
 
Event Description
Reporter indicated the patient may be seen by a neurosurgeon for evaluation of the patient¿s neck at the patient¿s request, but no surgery date has been set. The reporter declined to provide additional information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2405348
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dennis100
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« Reply #22 on: October 06, 2018, 06:24:18 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2016
Event Type  Injury   
Event Description
It was reported via social media comment by the patient that she experienced an asthma attack with magnet activation following the implantation of the vns. No additional relevant information has ben received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7872390
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dennis100
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« Reply #23 on: January 30, 2019, 09:12:41 AM »

Model Number 102
Event Date 08/01/2008
Event Type  Injury   
Event Description
It was reported that the vns patient¿s device was disabled and later explanted on (b)(6) 2013 due to respiratory issues. The patient previously experienced trauma to the airway and was respiratory issues during stimulation on-times even at low settings. The patient¿s explanted device has not been returned to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2009. The patient¿s device was disabled on (b)(6) 2010.
 
Event Description
Further follow-up revealed that the patient's device was programmed off on (b)(6) 2010 and that after a year with vns disabled the patient decided to pursue explant in the future. The patient first complained of respiratory stridor and shortness of breath symptoms in (b)(6) 2008. The vns was programmed off and an ent evaluation was performed. The patient's respiratory symptoms were better with vns off. The vns was programmed back on in 2009 and the patient required albuterol, prednisone and continued to have problems with shortness of breath. There was questionable asthma of new onset which was always relieved with vns off. Many attempts were made to continue vns and manage with asthma medications, but they did not help the severe shortness of breath attacks. The physician believes the vns stimulation is related to the patient's respiratory issues. The patient underwent a video stroboscopy in 2009, a vocal cord ct scan in 2011, and a diagnostic laryngoscopy under anesthesia and laryngeal emg in 2011. The patient had emergency room visits and trials with vns stimulation off then on then off again. No programming changes, medication changes, or other external factors caused or contributed to the patient's respiratory issues. The physician reported that the patient experienced prolonged intubation for a period prior to vns implant and possible structural problem of post glottis inlet. The physician reported that the patient's depression benefitted from vns therapy so the respiratory problems were tried to manage for years.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4059317
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dennis100
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« Reply #24 on: February 05, 2019, 03:23:56 AM »

Model Number 102
Event Date 10/13/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was going to the emergency room for asthma and difficulty breathing which worsened during vns stimulation on-times. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The treating physician's office reported that they are not aware of the patient going to the er for these symptoms, nor has the patient ever reported these type of events to their office. The patient¿s vns device was last checked on (b)(6) 2014, and it was functioning properly at that time. The office was unable to provide additional information at that time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4228385
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dennis100
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« Reply #25 on: February 13, 2019, 03:21:03 AM »

Model Number 103
Event Date 01/01/2015
Event Type  Injury   
Event Description
It was reported that patient's asthma attack was never a problem previously and the patient had a desat of 80. For intervention, the physician decreased the magnet and normal pulse width.
 
Manufacturer Narrative

Event Description
It was reported that the patient's mother indicated that the patient was taken to the hospital because he could not catch his breath and was coughing and wheezing. The hospital indicated that the patient was experiencing an asthma attack and would need to be placed on medication. The patient's mother reported that magnet mode stimulation was initiated during a seizure and the patient's asthma worsened and the patient could not catch his breath. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4517482
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dennis100
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« Reply #26 on: March 09, 2019, 03:27:20 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/30/2019
Event Type  Injury   
Event Description
It was reported that the patient was in the hospital with asthma. The clinician wondered whether the vns could contribute to the asthma. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8364063
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dennis100
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« Reply #27 on: July 20, 2019, 10:58:07 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/12/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported from the patient that she was in a car accident in 2012 and following this she was on disability and was not as active as before. She has also said that she has bad asthma following the accident, and as a result the patient would having wheezing, heaving and panting if her stimulation was on and her heart rate was up like taking the stairs. She stated that it was not shortness of breath but more like an asthma attack. She clarified that she had the device off for 3 minutes and on for 60 seconds. She was not able to exercise because of it. The patient said that she had already talked to her neurologist and he ¿turned the device down a bit¿ but it didn¿t help. She did state that she was pleased with the device and said ¿the stimulator helped her tremendously¿. Follow-up was made to the patient's last known physician. The nurse indicated that the patient was released from their clinic (b)(6) 2017. She looked through notes and was unable to locate any issues with vns from when they saw her previously.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7860540
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dennis100
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« Reply #28 on: August 10, 2019, 02:49:16 AM »

Model Number 10X
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported by the patient via social media that her vns was put in wrong. She said that her wire vertically entrapped her vagus nerve. She would get shocked when she swallowed at times or touched a grocery cart. She also reported that when her vns was being titrated up, it triggered asthma attacks and she had to go to the er. Later, the vns was removed, but the patient's voice turned into a whisper. After vocal cord injections and speech therapy, her voice came back but she couldn't sing. The current report captures the asthma and other stimulation related events reported as part of the story. Mfr. Report # 1644487-2019-01280, captures the report of voice alteration after device explant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8761498
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