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dennis100
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« Reply #840 on: April 24, 2018, 01:26:05 AM »

Model Number 103
Device Problem No Information
Event Date 01/01/2013
Event Type  Injury   
Event Description
A battery life calculation was performed which showed the generator had approximately 2 years remaining until a near end of service (neos) = yes condition. The programming history database was reviewed and showed the generator was working as intended through (b)(6) 2012. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
It was reported the vns generator was disabled as the patient experienced a lack of efficacy and due to intolerability of the magnet as the patient experienced brief apnea and voice alteration. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5312949
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dennis100
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« Reply #841 on: April 30, 2018, 01:48:07 AM »

Model Number 302-20
Device Problem High impedance
Event Date 05/09/2013
Event Type  Malfunction   
Event Description
It was initially reported that the patient had high impedance on systems diagnostics. There was no reported manipulation or trauma and there were no associated adverse events. The generator was not disabled. X-rays were taken but they will not be sent to the manufacturer for review. The patient did not want to do anything at the time but has since decided that he would like a replacement. Surgery if likely but has not occurred to date. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.
 
Event Description
The patient underwent a full replacement on (b)(6) 2015. It was stated that the generator will be returned but the lead will not. The explanted generator was received for analysis on 07/14/2015. Product analysis is currently underway but has not been completed and approved to date.
 
Event Description
On (b)(6) 2013, the patient reported that the device was still programmed on. The patient stated that her settings were 150/125, but the device was reading 75/100. The magnet mode stimulation felt the same. The patient stated that she did not realize ¿that¿s why she hasn¿t felt the quite the same. ¿.
 
Event Description
Product analysis for the m103 generator was completed and approved on (b)(4) 2015. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In the 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. 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.
 
Event Description
On (b)(6) 2015 it was reported that the patient was going to receive x-rays after high impedance was observed. It is stated that the patient had a mammogram and felt that the device was not operating correctly. She went to the neurologist and received warning for high impedance while running the device diagnostics. It was clarified that the high impedance issue from 2013 was not fixed. The patient feels that the vns has been working great and was not ok having surgery back in 2013 to fix the high impedance. The patient thought the device was not working properly due to the high impedance issue. The patient has not had device replacement to date.
 
Event Description
On (b)(6) 2013, the patient reported that the only complication she was having was labored breathing, especially when she worked out three to four times a week.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3150381
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dennis100
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« Reply #842 on: May 02, 2018, 02:04:19 AM »

Model Number 104
Event Date 05/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that the patient was having some vocal cord issues and the nurse practitioner had some questions about vocal cord paralysis and vns. The nurse practitioner explained that the patient had been hospitalized for respiratory failure that was not related to vns and was taken to an outside hospital where she had a tracheostomy and intubated. The patient still had the tracheostomy tube in place. The patient had their generator turned on following a generator replacement and had some coughing so the generator was turned off. The patient was scoped so the vocal cords could be examined. One vocal cord (not specified) was reported to be ¿sluggish¿ when the generator was turned on to test and stimulation was on it become paralysis. The patient had the generator turned off and was sent home. The patient then can back for another appointment and the ¿sluggish¿ vocal cord looked healthier but still become paralysis when then generator stimulated. The patient had x-rays performed and the lead appeared to be intact per the nurse practitioner. X-rays were not provided to the manufacturer for evaluation. It was decided to lead the vns off to allow the patient more time to heal and the office will evaluation the patient at a later time to determine the course of action. Further information was received that the same nurse practitioner told the company representative in the field that the vocal cord issue was not related to vns. Good faith attempts for additional information and clarification have been unsuccessful to date.
 
Event Description
Additional information was received that the physician is now feeling that the sluggish vocal cord or any of the related issues were related to vns and was related to a tracheotomy the patient had. The vocal cords was seen to be more sluggish with stimulation so the patient was having their generator left off until the vocal cord shows improvement. The patient had been intubated, ventilated then trached and ventilated in the month before the issue was discovered. The patient a recent generator replacement but the lead was not replaced so there should not have been any manipulation of the vagal nerve. There was also an ent involved that was helping evaluate the patient. When the patient was scoped the left vocal cord was sluggish with no stimulation and was more sluggish with stimulation. Diagnostics were within normal settings. They are going to slowly increase the patient¿s settings but the vns will remain off until the vocal cord show improved movement. The patient does not have a history of vocal cord issue.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3198567
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dennis100
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« Reply #843 on: May 03, 2018, 01:45:54 AM »

Model Number 103
Event Date 08/01/2011
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 that the patient has an oxygen monitor shows oxygen levels drop several times a day which may lead to the patient turning blue. The patient¿s jerks are not necessarily associated with these episodes. The patient had a reduction in the tonic episodes and the oxygen drops at the last visit, but he has had a significant increase in (b)(6) 2011. The seizures range from 673-1477. There was noted to be no obvious etiology for the increase in seizures since the recent ear infection for which he was given a medication for ear infections. On (b)(6) 2013, the patient¿s seizures (myoclonic and tonic episodes and staring) were noted to range from 362 and 916. ¿he has been very agitated for about two weeks. ¿ the patient¿s medication appeared to be helping the patient except the previous month, per the caregiver. On (b)(6) 2013, he had been on a medication for ear infections for 10 days. On (b)(6) 2013, the physician noted that given the number medications and doses, no medication dosing changes were made. The physician¿s impression in the notes showed that it is unclear whether the seizures are primarily generalized tonic episodes or secondarily generalized seizures. Follow-up was performed with the treating physician who assumed care for the patient after initial implant. He reported that he does not believe the increased seizures were related to vns in 2011 or potentially 2013. He was unable to say if it occurred in 2013, but the patient's seizures have never been under good control. He actually believes the patient has a very bad seizure disorder, and the reason the seizure are "34;out of control"; is due to bad respiratory compromise. "in other words, he has tracheostomy and bad lungs, and he has a lot of times when his oxygenation goes down. A lot of his seizures are related to that rather than other else. " the physician has been trying to get the patient monitored to correlate the relationship of the seizures and desaturation, but the monitoring has not occurred to date. He believes the patient's seizures are mostly caused by the desaturation. The relationship between the desaturation and sleep apnea to vns is unknown because he needs to be monitored via sleep study to see if saturation improves when the vns is turned off. The onset of the sleep apnea/desaturation is unknown. Diagnostics on vns were okay as far as the physician knows. He reported that the caregiver reported they want the vns replaced so the physician agreed. The patient has not exhibited any other symptoms that may be related to vns. He did not know the relationship of the increased seizures to pre-vns seizure frequency. This report captures the patient¿s increased seizures since the relationship of sleep apnea/desaturation to vns is unknown to date. Manufacturer report number 1644487-2013-02099-2013-02100 captures the desaturation and sleep apnea. The patient had generator replacement in 2009. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3224901
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dennis100
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« Reply #844 on: May 04, 2018, 01:45:17 AM »

Model Number 304-20
Device Problem High impedance
Event Date 04/03/2018
Event Type  Malfunction   
Event Description
It was reported that high impedance was identified on (b)(6) 2018 on the patient's device. The device was programmed off in response to the high impedance, and the patient was referred to the surgeon for x-rays. The surgeon planned to review the x-rays and decide the plan of action at that time. The patient recently had generator replacement surgery on (b)(6) 2017, and the settings were. Diagnostics were. The patient had not had any trauma to the site and falls, and he lived in a group home with one to one nursing care. The patient does have a trach, so it was possible that the trach could have pushed on the lead, albeit unlikely. The physician decided to review the x-rays himself, and they were not provided to the manufacturer. No surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7463455
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dennis100
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« Reply #845 on: May 05, 2018, 01:03:44 AM »

Model Number 104
Device Problem No Known Device Problem
Event Date 03/22/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient had stridor and their spo2 was at 86% when the output setting was at 1. 25 ma and 89% when the output setting was at 0. 75 ma. The patient settings were then set to 0. 25 ma for normal stimulation and 0. 50 ma for magnet stimulation. It was verified that no stridor was noted at these settings. Systems diagnostics were performed on the device a few days later and were noted as ok. No trauma was reported by the patient. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7444698
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dennis100
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« Reply #846 on: May 06, 2018, 02:06:26 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 09/01/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient reported that they were having difficulty swallowing, catching their breath, and felt some tightness in their throat. It was reported to first occur with magnet stimulation, and has been getting worse in the past six months. The patient stated that recently the difficulty swallowing, catching her breath and tightness in her throat is constant, and not only occurring with stimulation. The patient stated that they were hospitalized and an upper gi test was performed that came back negative. The patient has not seen a neurologist in some time and was questioning if her battery needed replacement. The patient does not have a current neurologist she visits. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7403911
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dennis100
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« Reply #847 on: May 11, 2018, 01:22:13 AM »

Model Number 102
Event Date 09/10/2012
Event Type  Injury   
Event Description
It was reported that a vns patient was going to have their generator explanted on (b)(6) 2012. The explant was due to the device being turned off for the past 2-3 years. The device was disabled due to a respiratory event. The patient's physician did not think it was an arrest, but did not know what exactly occurred. The generator and most of the lead (not electrodes) was explanted. Further information has not been received at this time.
 
Manufacturer Narrative

Manufacturer Narrative
Suspect medical device type of device: patient implanted for depression not epilepsy.
 
Event Description
At this time the patient's explanted product has not been returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2850378
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dennis100
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« Reply #848 on: May 14, 2018, 03:09:46 AM »

Model Number 302-20
Event Date 05/09/2011
Event Type  Injury   
Event Description
It was initially reported by the epileptologist that the patient was to undergo a prophylactic generator replacement, and at the same time have his lead released from scar tissue. Additional information was received through an implant card indicating that the patient's lead was replaced and the patient had been experiencing coughing, tightness in the lead, and difficulty breathing. A review of the patient's history showed that the patient was implanted in 2006. The patient had started experiencing pain and tightness in his neck, following implant. This resulted in a procedure to release his lead wire from scar tissue in (b)(6) 2009. At that time, the procedure was performed for patient comfort. Follow up with the surgeon revealed that the patient's pain and tightness had reoccurred approximately a year after the previous surgery. The symptoms had gradually worsened, until it caused the patient pain and coughing when he turned his head to the right. During the procedure to loosen the lead wire from the scar tissue, the surgeon noticed damage to the "lead sheath" so he replace the lead wire. He indicated that the patient had developed severe fibrosis which entrapped the cable causing the pain, coughing, and discomfort. The fibrosis was also restricting the patient's neck motion. The surgeon stated that the procedure was performed primarily for patient comfort, but also potentially to preclude a serious injury. Follow up for additional information regarding the damage to the lead has been unsuccessful to date. The explanted products have not been returned to the manufacturer for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2129926
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dennis100
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« Reply #849 on: May 30, 2018, 03:46:34 AM »

Event Date 05/21/2002
Event Type  Injury   
Event Description
It was reported in a scientific article reviewed by the manufacturer that the vns epilepsy patient was subject to overnight polysomnographic recording of cardiorespiratory activity. During the recording, signals were collected from an ecg, thoracic and abdominal piezoelectric sensors, a nasal thermistor, eight eeg leads, an oxygen saturation monitor, and a chin emg. The physician observed that this child experienced a decrease in the respiratory sinus arrhythmia (rsa) magnitude. This patient's rsa magnitude varied from the baseline by a factor of -2. 9228+/-1. 4179. The decrease started and ended abruptly with the onset and end of vns. The decrease in rsa magnitude was concomitant with no obvious effect on the patient's heart rate. The physician notes that the observed effects of vns on rsa may result from the following four possible factors: activation of brainstem loop via stimulation of afferent fibers, alteration of vagal afferent tone which modulates specific tonic and phasic parasympathetic efferent fibers, activation of efferent vagal fibers in the case of partial vns anodal block resulting in disturbance or abolition of physiologic efferent phasic and tonic firing or additive excitatory input to the heart, or a combination of both efferent and afferent vagal fiber stimulation. In addition, changes in respiratory due to vns could also modify rsa. The physician indicates that "rsa can be altered during each vns period and gas exchange performance can, therefore, be repeatedly altered. This must be taken into account together with repeated hypoxic- and hypercapnic-induced transient effects in subjects with already disturbed brain function when evaluating vns side effects. " in addition, the physician indicates that altered rsa and cardiorespiratory synchronization may also affect the epilepsy-related alteration of sympathetic-parasympathetic balance due to either epilepsy, or chronic usage of antiepileptic medication. The physician indicates that the interaction between the effects of vns and potential autonomic nervous system (ans) dysfunction in epileptic patients may be considered to be a potentially life threatening condition, although no serious injuries specific to this event were noted with this particular patient. The physician also states that the understanding of these processes in epilepsy is limited, and suggests further evaluation of respiratory changes during vns. This patient also included in an article by the same author title "vagus nerve stimulation induces concomitant respiratory alterations and a decrease in sao2 in children" which was reported in manufacturer report # 1644487-2006-00105.
 
Manufacturer Narrative
Zaaimi, b. , grebe, r. , berquin, p. , wallios, f. Vagus nerve stimulation induces changes in respiratory sinus arrhythmia of epileptic children during sleep. Epilepsia: 1-8, 2009. Doi:10. 1111/j. 1528-1167. 2009. 02190. X.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1471011
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dennis100
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« Reply #850 on: June 06, 2018, 01:55:02 AM »

Event Date 11/09/2007
Event Type  Death   
Event Description
Additional information was received in regards to the patient's health history. The patient has a history of cerebrovascular accident prior to vns implantation. They had right arm and right leg weakness as a result of this. They additionally had a history of alzheimers versus multi infarct dementia onset prior to vns implantation. They had diabetes, hypertension, a pacemaker implanted, coronary artery disease with stent placement, chronic obstructive pulmonary disease and a history of recurrent bacteremia onset prior to vns implantation. Their vns generator had been implanted near their right clavicle with their leads on the left vagus nerve. Diagnostics at time of implant were reported to be within normal limits, (b)(6) 2005. The patient has a history of poor seizure control with extended postictal periods where she has to be admitted for iv fluids till she awakens. No further information has been received at this time.
 
Manufacturer Narrative

Event Description
It was reported that a vns patient died on (b)(6) 2007. No further information is known at this time. It is unknown the relationship of their death to their vns, nor the circumstances of their death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2766892

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dennis100
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« Reply #851 on: June 08, 2018, 03:25:11 AM »

Model Number 1000
Device Problem No Known Device Problem
Event Date 04/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient had recently undergone initial vns implantation surgery. The patient's grandmother stated that when swiping the magnet, the seizures seem to get worse. It was also stated that the patient was making sounds in her sleep, which were described as weird breathing noises. The patient's diagnostics were within normal limits. At the clinic visit, the magnet was swiped several times and did not appear to have any effect on the patient, but it was reported that the patient got tired. The patient has a history of sleep apnea and was referred for a sleep study. The patient's pcp was not concerned and was prepared to continue titration of the vns therapy, but the neurologist wanted to want until after the sleep study. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7542232
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dennis100
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« Reply #852 on: June 09, 2018, 02:33:36 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 06/11/2008
Event Type  Injury   
Event Description
It was reported in 2012 that the patient's father called asking for the patient's records from time of implant until when the device was turned off. He believed that the vns almost killed her. Per the father, the patient had aspiration pneumonia and had been admitted to the emergency department. When follow-up was conducted with the physician¿s office in 2012, the physician¿s office stated that the patient had a past history of problems with aspiration even prior to the vns, so they didn¿t believe it was related to the vns or stimulation. The vns was turned off at the family¿s request approximately two months after implant. In 2018, further information from the father was received. He reported that the patient was now in respiratory failure and had had quite a few aspiration and pneumonia events. He stated that the patient hadn¿t had aspiration events prior to the vns. The father believed that one instance of aspiration pneumonia, that had occurred ¿a while ago,¿ had been caused by a feeding tube that he said was needed because the patient couldn¿t swallow due to the vns. Since then, the patient had had multiple instances of aspiration pneumonia due to influenza, which the father did not suspect were related to the vns. Later he indicated that the patient had had multiple aspiration pneumonia events due to the vns. The father reported that the patient had issues with the vns such as throat pain, inability to speak, and inability to swallow food. He said that the patient¿s vns had been disabled permanently between 2012 and 2014 because the patient¿s ent had attributed the dysphagia to the vns. Per the father the ent had looked at the patient¿s throat while the magnet was swiped and the patient¿s throat did not close. Per the father, because the patient¿s throat remained open, fluid and other things could get into lungs, leading to pneumonia. Finally, the father reported that the patient¿s physician had told him that there had never been any problem with the vns. Further follow-up with the physician¿s office found that this father frequently reported this complaint to them and that the patient was recently admitted to the hospital with pneumonia. The physician indicated that he couldn¿t provide an assessment of the events reported by the father until he saw the patient again. No further relevant information has been received, to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7497099
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dennis100
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« Reply #853 on: June 10, 2018, 01:01:16 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 10/31/2017
Event Type  Injury   
Event Description
It was reported by the patient's sister that her brother had recently been diagnosed with left vocal cord paralysis by an ent. He could barely talk and was having wheezing sounds when he talked. The issue began after his recent generator change. This issue was affecting his ability to work. The vns settings were slightly reduced, but this only slightly improved the issue. The ent recommended that the patient get collagen injections and a ct scan. The sister reported that the patient had an upper egd and respiratory issues recently (not alleged against the vns), but the ent and the pcp said that this would not cause the vocal cord paralysis. At the patient's next appointment, his generator's system diagnostics were within normal limits. The patient's device settings were reduced due to the vocal issues. A little less than a month later, the patient's physician reported that the patient had little to no change in settings prior to the patient's symptoms. The physician believed that the vocal cord paralysis may be related to the intubation for the upper egd study as well as intubation, if used, for the generator replacement. The patient was reportedly feeling much better at this appointment and could speak much more clearly, which the physician attributed to the patient's decrease in settings at the last appointment. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7478437
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dennis100
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« Reply #854 on: June 11, 2018, 12:41:41 AM »

Model Number 101
Event Date 01/01/2008
Event Type  Injury   
Event Description
It was reported that a patient's device was programmed off due to severe contractions in the diaphragm which could cause the patient to vomit every three minutes. This event started after the patient's output current was increased from 1. 25 ma to 1. 5 ma. Initially, the settings were lowered to 1. 0 ma which resolved the symptoms however, the device was programmed off at the patient's request. The patient does have hiatus hernia and other gi issues and it is unclear if these are related to the device. It should be noted that the generator is currently at end of service therefore, diagnostics cannot be performed. The device will not be removed at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1665708
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« Reply #855 on: June 13, 2018, 12:13:06 AM »

Model Number 106
Event Date 03/17/2016
Event Type  Injury   
Event Description
It was reported by the physician that the patient had been intubated for pneumonia. The cause of the pneumonia is unknown. On (b)(6) 2016, the patient started experiencing bradycardia that lowered his heart rate into the 60s (for beats per minute) every 3. 5 minutes. At that time, the patient's vns was programmed to 30 seconds on and 3 minutes off. It was also noted the patient had plural effusion, which had enlarged and put pressure on the cavity, which initiated the vns and caused the bradycardia. The physician stated the duty cycle was lowered to 21 seconds on and 5 minutes off, and the output current was also lowered. Lowering the patient's vns duty cycle and output current resolved the issue. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was later reported by the physician that the pneumonia was not caused by or related to vns. Additionally, the patient's vns therapy settings were reported, but no diagnostic results were reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5574948
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dennis100
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« Reply #856 on: June 13, 2018, 12:13:46 AM »

Event Date 01/01/2008
Event Type Injury
Event Description
Review an article written in reference to the vns therapy system revealed the following excerpt "a review of available literature suggests that the cardiac or respiratory problems that theoretically may be a concern with vagus nerve stimulation are rarely of clinical significance. " the excerpt was taken from an article titled "cardiorespiratory variables and sensation during stimulation of the left vagus nerve in patients with epilepsy". 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=1176174
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« Reply #857 on: June 23, 2018, 12:27:27 AM »

Model Number 102
Event Date 05/15/2010
Event Type  Death   
Event Description
It was reported by a pt's physician that the pt passed away as a result of complications from lung surgery. The exact relationship to the death and vns is unk. The pt was buried. Good faith attempts to obtain additional info are currently being made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1745508
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« Reply #858 on: July 06, 2018, 11:09:16 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 04/19/2018
Event Type  Injury   
Event Description
It was reported that this vns patient listed above was diagnosed with partial vocal cord paralysis. It was stated that the patient has been having severe hoarseness and was having difficulty breathing/coughing. It was reported that these problems existed since surgery. The vns was found to have been programmed on post-op. No interventions are known to have been planned or taken to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7578785
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« Reply #859 on: July 16, 2018, 01:40:42 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 12/29/2016
Event Type  Injury   
Event Description
Clinic notes reported that a patient was experiencing difficulty breathing, throat tightness, and hyperventilation. The patient and physician were initially unsure if the symptoms were related to vns. The physician later reported that the patient experienced voice alteration and throat tightness when her device output current was increased, believing that the voice alteration and throat tightness were related to vns. The physician increased the frequency to resolve the patient's voice alteration and throat tightness. Additionally, the physician decreased the patient's vns off time while maintaining the same vns output current, vns on time, and medication schedule to help with the voice alteration and throat tightness. The physician reported that the intervention taken was required to preclude a serious injury. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6727261

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« Reply #860 on: July 22, 2018, 03:07:37 AM »

Model Number 304-20
Event Date 10/12/2012
Event Type  Injury   
Event Description
It was initially reported that the patient had severe hoarseness since date of implant, and there was consideration at that time to refer the patient to ent for botox injection in the vocal cord area due to possible laryngeal nerve damage. Upon follow-up, it was reported that the patient saw the ent on (b)(6) 2016. The ent noted that the patient had an underlying sleep breathing disorder. The ent discussed that the patient had left vocal paresis that was likely due to the vagal nerve stimulator implant. The ent assessed that given that he is not having significant problems with his voice or airway, the ent recommended observation. Per the reported diagnostics, the device is functioning properly. It was also noted that the patient recently had a tonsillectomy and adenoidectomy, in which the left vocal cord paralysis was initially noted. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient's treating medical professional did not think the vocal cord paralysis was related to the vns as the vns surgery had occurred some time ago. No additional relevant information has been received, to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6064969
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dennis100
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« Reply #861 on: August 07, 2018, 01:24:35 PM »

Device Problem No Known Device Problem
Event Type  Injury   
Event Description
It was reported via social media that somebody's friend had their vns explanted due to "breathing problems. " no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7631509
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dennis100
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« Reply #862 on: August 11, 2018, 01:28:11 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/12/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient has neck swelling and that the patient had a recent placement of the vns on the left. The patient also has sensation of throat tightening. The patient was assessed left vocal cord paralysis was identified and abnormal asymmetric thickening of the left aryepiglottic fold which lies cephalad of the paralyzed left vocal cord. There was also a 13 mm solid nodule at the inferior pole of the left thyroid lobe. The patient¿s device has not been programmed on yet. Information was received from the patient that she can barely talk or breathe. The likely cause of the paralysis was from the surgical procedure. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7678836
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dennis100
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« Reply #863 on: August 11, 2018, 01:28:37 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/18/2018
Event Type  Injury   
Event Description
It was reported that a vns patient recently had her device adjusted. She began experiencing coughing and respiratory issues. The coughing occurs roughly every 3 minutes. She had the parameters reduced back to the previous settings. The coughing and the respiratory issues did not resolve. She taped the magnet over the device and the issue resolved. She stated that her daughter does have underlying respiratory issues. Follow-up from the company representative later provided that the caregiver had placed the magnet over device for over 12 hours, and at first it helped. It was stated her oxygen saturation was going lower, possibly as a result of the coughing. They were concerned the vns was causing respiratory distress. The company representative provided she observed the patient cough when they removed the magnet. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7687277
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dennis100
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« Reply #864 on: August 11, 2018, 01:29:03 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/15/2016
Event Type  Injury   
Event Description
It was reported that a vns patient was experiencing an onset of pulmonary symptoms at night and the physician and patient believe that vns could be contributing. The symptoms were provided as snoring. Follow-up to the physician revealed that a sleep study has not been done, but the patient reports snoring at night during stimulation. It was stated the snoring is occurring only at night and only during the device on time. The device was reported to be disabled due to the snoring. The physician reported the diagnostics were always good. Clinic notes were received 06/20/2018 for a replacement referral. The notes indicate the replacement is due to nocturnal respiratory issues, with side effects of snoring. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7685794
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dennis100
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« Reply #865 on: August 11, 2018, 01:29:37 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a patient's device would be explanted. Upon follow-up on the reason for explant, it was stated that the patient was having difficulty breathing over the past year. The patient had seen several doctors regarding the breathing issues and no doctor was able to determine the reason for the issues. The physician lowered settings for the difficulty breathing. It was unknown if this improved the patient's symptoms. A company representative attended the patient's appointment and noted that the patient was visibly swallowing hard and that the patient was also reporting tightness that occurred about 4-5 times a day. Settings were adjusted. The physician was unsure if the events were related to stimulation. Lead impedance was indicated to be ok. It was noted that the patient's device was replaced. The hospital was noted to be a no return site so the explanted generator will not be returned for analysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7701207
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dennis100
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« Reply #866 on: August 26, 2018, 01:44:48 AM »

Model Number 102
Event Date 01/01/2007
Event Type  Injury   
Event Description
It was reported to the mfr by a caregiver that six months following vns implantation, the pt's mucus had gotten really thick and gummy. The pt has also developed a lot of bacterial problems such as bronchitis and mouth sores. The bronchitis was treated with antibiotics. The pt's caregiver was suggested to use the magnet to temporarily disable the device to see if the pt's mucous gets better. It is unk if vns therapy caused or contributed to the reported event. Good faith attempts to obtain add'l info regarding the reported event have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1772211

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dennis100
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« Reply #867 on: August 26, 2018, 01:45:37 AM »

Model Number 102
Event Date 01/01/2012
Event Type  Injury   
Event Description
It was reported that the patient will not be reimplanted. It was reported that the patient's parents cannot afford the costs.
 
Event Description
It was reported that the patient's tracheostomy wound became infected which was unrelated to vns therapy. It was reported that the patient has lost weight as a result of the infection and that the generator is now protruding. It was reported that the patient's skin is stretching and ampoules are starting to appear. It was reported that the patient is being seen by a nutritionist and an infectiologist. It was reported that the patient's weight loss was secondary to recurrent bronchitis that the patient experienced in 2012. The patient's tracheostomy was placed in 2005. The physician indicated that the protrusion is more likely a consequence of the weight loss rather than a rejection of the device. No interventions have been taken at this time.
 
Event Description
It was reported that the patient underwent generator and lead explant. At the time of explant, it was noted that the generator had begun extruding. A biopsy of the necrotic tissue was taken. It was reported that the culture grew (b)(6) in the tissue surrounding the generator. It is unknown if the patient will be reimplanted at a later date. The generator was returned to device manufacturer on 06/17/2013. The generator analysis is underway; however, has not been completed to date.
 
Event Description
Generator product analysis was approved on (b)(4) 2013. The dhrs for the generator and lead were reviewed, which confirmed both generator and lead met all final testing specifications and sterilization standards prior to distribution. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3135361
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dennis100
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« Reply #868 on: August 26, 2018, 01:46:39 AM »

Event Date 05/14/2012
Event Type  Injury   
Manufacturer Narrative
Date of event, corrected data: the correct event date is provided per the reporter. Suspect medical device, corrected data: the incorrect device (generator) was inadvertently reported on the initial mdr report. The correct device (lead) is provided. Implant date, corrected data: the correct implant date for the lead product is provided. The date is approximate, as only the year was provided.
 
Manufacturer Narrative

Event Description
Reporter indicated the patient had left vocal cord paralysis ("lesion") which was diagnosed on (b)(6) 2012, by an ent specialist during a hospital stay for fever and bronchitis. While the cause of the left vocal cord paralysis is unknown, a link to the vns is suspected. The patient's vocal cord health history prior to the vns is unknown, but the vocal cord paralysis was not present before the vns. It is not known if the left vocal cord paralysis is occurring with stimulation, and the patient had no preceding vns setting changes or medication changes. Vns diagnostics were reported to be within normal limits, but were not specified. No interventions have been performed, and the plan of care is to monitor the patient. The patient's date of birth and vns lead implant date are approximate, as only the year was given by the reporter.
 
Event Description
It was reported by a physician through a company representative that a vns patient experienced vocal cord paralysis due to unknown reason. The patient was reported as a long term user for vns therapy and was not sure if the event was related to vns usage. The patient is able to speak and swallow however at the moment good faith attempts to obtain further information from the reporting physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2635931
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dennis100
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« Reply #869 on: August 26, 2018, 01:47:23 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/29/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient's vns was disabled for three days as it was felt that the vns aggravated the patient's bronchitis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7562029
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