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dennis100
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« Reply #90 on: June 17, 2016, 02:13:48 AM »

Model Number 106
Event Date 04/14/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
Patient was admitted to the icu due to a stroke and was in status. The etiology on what could have caused the patient's stroke was unknown to the treating physician. The patient has a baseline cognitive delay so communication with the patient is difficult. The doctor had identified three or four seizures and had provided medical treatment outside of the vns. Additional relevant information have not been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5640437
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dennis100
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« Reply #91 on: July 09, 2016, 01:35:19 AM »

Model Number 105
Event Date 09/01/2010
Event Type Injury
Event Description
Cyberonics vns - for epilepsy patients. Two surgeries. Two separate devices, worsening, depression. Device malfunction could be fatal. First vns - implant constantly malfunctioned left scar tissue caused death/resuscitation in operating room. Caused stroke 2 times, caused permanent damage to heart/body, second device caused permanent damage and could be end by death to my life. Nerve damage, permanent sensitivity to touch, damaged nerves/pain, heart problems, scar tissue. Neuropathy could result in death. Cyberonics recently called, and they stated the surgery never should have been done. Pt id: (b)(6). Chart # at operating room: (b)(6). Surgeon: (b)(6). Surgical operating room/extended adm: (b)(6) 2015. Csn: (b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5700328
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dennis100
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« Reply #92 on: August 05, 2016, 09:30:48 AM »

Event Date 09/01/2010
Event Type Malfunction
Event Description
A voluntary medwatch was submitted to the fda and received by the manufacturer with the report number mw5062653. It was reported that after the patient's initial vns implant, which occurred on (b)(6) 2010, that the patient had worsening depression and the device malfunctioned and could be fatal. It was noted that this first implant was constantly malfunctioning and left scar tissue, which caused death/resuscitation in the operating room. It was reported the device caused a stroke two times, and caused permanent damage to the heart/body. The manufacturer's internal databases were reviewed; however, the patient information was unable to be identified based on the lack of information reported on the voluntary medwatch. Additional information related to a second implanted vns is captured in mfr. Report # 1644487-2016-01519.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5772209
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dennis100
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« Reply #93 on: December 09, 2016, 10:32:16 AM »

Event Date 01/01/2016
Event Type Injury
Event Description
It was reported by a gentleman who was a vns patient that he sat next to another vns patient on the bus. This other patient reported he had his vns removed because he believed that vns caused him to have a stroke. The patient who had the stroke's identity nor his physician's identity was given. No additional relevant information has ben received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6080087
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dennis100
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« Reply #94 on: March 10, 2017, 04:39:52 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 02/26/2013
Event Type Death
Event Description
It was found through a search of candidates that may need battery replacement that this patient had passed away in a hospital. Prior to death, the patient had a stroke and was diagnosed with congestive heart failure. The patient's neurologist indicated that the cause of death was probably old age. The cause of death and its relationship to the vns device is unknown. The patient's available programming history was reviewed. System diagnostics were within normal limits and no anomalies were found. No additional relevant information has been received to date. The product has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6323845
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dennis100
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« Reply #95 on: May 08, 2017, 01:17:23 AM »

Model Number 303-20
Event Date 07/21/2014
Event Type Injury
Event Description
It was reported that the patient had a seizure a month prior and was "out" for 36 hours. The patient reported that it is believed that the seizure may have potentially been a stroke and plans to follow-up with the physician. The patient also reported that it is now difficult to swallow properly and that he has right vocal cord paralysis. Attempts to obtain additional relevant information has been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4102868
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dennis100
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« Reply #96 on: May 10, 2017, 01:09:20 AM »

Model Number 302-20
Device Problem Improper or incorrect procedure or method
Event Date 10/01/2014
Event Type Injury
Event Description
Additional information was received that the patient underwent surgery. During the surgery, the physician noted that the entire vns lead and tie-downs were not previously removed. The physician also noted scar tissue formation around one of the arteries leading to the brain with a 50% chance of a stroke.

Event Description
Additional information was received that the patient has an abscess on the left side of his throat which is pressing on the vocal cord and could lead to vocal cord paralysis. A neck and chest ct was performed which showed that a part of the vns leads and a tie down were not explanted previously. The physician believes that the presence of the device may be contributing to an infection. Patient is scheduled to have the abscess drained. Attempts for additional relevant information were unsuccessful.

Event Description
Additional information was received that the patient continues to have voice hoarseness that is better in the morning but worsens as they day progresses. According to the ent physician, the patient may need another surgery if patient's voice does not improve.

Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: 10/6/2015. The previous supplemental mdr #9 incorrectly lists the aware date as 08/04/2015. The correct aware date is 10/06/2015.

Event Description
Additional information was received that the patient's hoarseness has resolved per the ent. However the patient will never be able to speak loudly. Patient's neurologist decided to not replace the vns device as patient has had only one seizure since (b)(6) 2015.

Event Description
Additional information was received that the patient underwent explant of the vns generator and lead on (b)(6) 2014.

Event Description
Additional information was received that the patient's voice is normal and that the patient is better currently.

Event Description
Additional information was received that the patient continues to have voice issues and that the patient plans to have surgery to address this. Patient's seizures were reported to be under control.

Manufacturer Narrative

Event Description
Additional information was received that the patient will be undergoing another vocal cord surgery on (b)(6) 2015. Per the ent, the portion of the lead that was left implanted at the time of generator explant caused vocal cord infection, resulting in vocal cord paralysis.

Event Description
It was reported that the vns patient was seen by a dermatologist due to a pimple on the patient¿s neck. The dermatologist removed the pimple and also pulled out what appeared to be a surgical staple from under the patient¿s skin. Subsequently, the patient¿s lead was extruding under the patient¿s skin and the patient began experiencing pain at the lead site. The patient¿s device was tested and diagnostic results showed normal device function. The patient was referred for surgery but no know surgical interventions have occurred to date.

Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: 09/08/2015. The previous supplemental mdr #7 incorrectly lists the aware date as 08/04/2015. The correct aware date is 09/08/2015.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4274290
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dennis100
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« Reply #97 on: August 02, 2017, 12:29:42 AM »

Event Date 06/22/2011
Event Type  Malfunction   
Event Description
A physician's office reported that the pt had received a high impedance on diagnostic testing. The pt's last known settings were from (b)(6) 2010. The pt was sent for x-rays, which did not show any anomalies after review by the mfr. There was no known trauma to the pt. Due to vocal cord paralysis on the pt left and right vocal cords from a neonatal stroke, the physician is not willing to perform a lead revision surgery, only a generator one. Furthermore, the pt may require a trachea tube. The pt is currently seizure free and not taking any medications. The mother of the pt decided to proceed with a second opinion before scheduling a surgery. A surgery in the future is possible. Attempts for further info have been unsuccessful.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. Results: x-rays reviewed by the mfr, no gross lead discontinuities visualized. Conclusions: device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2193144
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dennis100
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« Reply #98 on: October 28, 2017, 02:54:30 AM »

Model Number 103
Event Date 12/14/2012
Event Type Injury
Manufacturer Narrative

Event Description
It was initially reported that the patient was hospitalized due to bradycardia and there was an episode of asystole. The patient was being considered for a pacemaker. No further information was provided. Additional information was received that the patient had gone to the hospital due to a fall, not related to vns. She has a subarachnoid bleed and the ct scan showed no occlusions. Before the patient was discharged she was attached to heart rate monitor. While on the heart monitor there were 10 seconds of asystole. They were preparing to administer cpr but the patient came back on her own. They then sent her for an ekg which was normal with the vns remained on, and the patient had normal sinus rhythm. No mentioned of bradycardia. As the cause of the asystole is unknown, there is no additional information or other causes that was obvious vns and vns is being suspected. The arrhythmias are not occurring with stimulation but it is suspected that it is secondary to vns. The patient is being evaluated for a pacemaker. The patient does not want to have their device disabled as she has been doing very well with vns. It was also noted that the patient has a history of recurrent stokes, relationship to vns was not provided. The physician declined to provide any additional information regarding the arrhythmia or stokes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2918874
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dennis100
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« Reply #99 on: November 13, 2017, 03:00:52 AM »

Model Number 104
Event Date 12/04/2014
Event Type Injury
Event Description
Patient underwent generator explant on (b)(6) 2014. It was also reported that the patients seizure rate prior to the explant was better than pre-vns baseline levels. It was mentioned that the patient has experienced mini-strokes that are believed to be exacerbating the seizures. The mini-strokes are not related to vns therapy.

Manufacturer Narrative

Event Description
Clinic notes were received indicating that the vns patient¿s device showed an ifi condition so the patient was referred for surgery. Follow-up revealed that the patient had been experiencing an increase in breakthrough seizures. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377485
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dennis100
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« Reply #100 on: November 17, 2017, 03:39:44 AM »

Model Number 102R
Event Date 01/20/2015
Event Type Death
Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
Death certificate was received on (b)(6) 2015 and indicated the following additional information. The patient¿s place of death was in the hospital. Disposition of the deceased was burial. Manner of death was not indicated. Cause of death was respiratory failure (minutes) / status epilepticus (days)/ sepsis (days)/ urinary tract infection (days). Other significant conditions contributing to death were indicated as profound mental retardation, history of stroke, seizures. Autopsy was not performed. Programming history was reviewed for the patient¿s device. The last known settings system diagnostics were from (b)(6) 2010 and were within normal limits.

Event Description
It was reported that the vns patient passed away on (b)(6) 2015. The cause of death and its relationship to vns are unknown. The patient¿s device was explanted and was returned to the manufacturer for analysis. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. There is no evidence to suggest an anomaly with the returned portions of the device. Note that since the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead. Attempts for additional relevant information have been unsuccessful to date. Based on the limited available information about the patient¿s death, an internal classification has determined that the death may be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4699334
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dennis100
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« Reply #101 on: December 06, 2017, 02:50:54 AM »

Model Number 105
Device Problem Device inoperable
Event Date 10/20/2015
Event Type Malfunction
Event Description
Additional information was received that the patient is able to inhibit stimulation by holding the magnet over the generator. Proper magnet swiping technique was verified and the magnet was not deep in the tissue or tilted. Troubleshooting revealed that the patient swiped her magnet and did feel stimulation, and the magnet swipe was registered upon interrogation. Information was received that the magnet is not often useful in aborting the patient's seizures because the patient normally cannot swipe the magnet in time, not suspected to be caused by a generator issue. It was reported that there are no longer any suspected issues with the patient's generator. No additional relevant information has been received to date.

Event Description
It was reported that vns was never efficacious per the mother. Per the mother, the seizures have never changed post-implant. No surgical intervention has occurred to date. No additional relevant information has been received to date.

Event Description
It was reported that the patient was experiencing shortness of breath with device stimulation. Device diagnostics were within normal limits and device settings were reduced. The physician believes the patient is overly sensitive to device stimulation. The patient was reported to be fine after device settings were reduced. It was reported by the patient's mother that they want the vns explanted due to painful stimulation in the neck, breathing difficulties with device stimulation during exertion. The mother reported that since the patient has had difficulty tolerating stimulation and they had not noticed any efficacy the device was disabled for three months. The device was then programmed back on to a very low setting. The stimulation is now tolerable. The mother reported that recently the patient has experienced a change in seizure type and has also had a transient ischemic attack which has contributed to her current state. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Manufacturer Narrative
Corrected data: this information was inadvertently left off of supplemental mfr. Report #01. Corrected data: "it was reported that the patient was experiencing shortness of breath with device stimulation. Device diagnostics were within normal limits and device settings were reduced. The physician believes the patient is overly sensitive to device stimulation. The patient was reported to be fine after device settings were reduced. " this information was inadvertently left off of supplemental mfr. Report #01.

Event Description
Follow-up with the surgeon's office revealed that the mother called their office in (b)(6) 2016 and wanted the patient to get a head mri due to increased headaches (with no allegation against vns). However, they had not seen the patient since 2014. The mother had mentioned wanting a mri and vns explant to the last treating physician's office. No surgical intervention has occurred to date. No additional relevant information has been received to date.

Event Description
It was reported that the patient's vns magnet mode is not thought to be functioning. It was reported that the patient cannot feel magnet activations and the magnet swipes are (b)(6) 2015 and one on (b)(6) 2015. The patient also experienced a cluster of seizures on (b)(6) 2015 that the magnet was not able to abort. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5216170
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dennis100
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« Reply #102 on: February 04, 2018, 02:24:50 AM »

Model Number 302-20
Event Date 03/24/2011
Event Type Malfunction
Event Description
On (b)(6) 2011, a vns treating physician reported that the vns patient was presenting with high lead impedance from a systems diagnostic test that showed limit/high/7/no that day. The physician said that the patient doesn't know of any specific incident that could have resulted in a potential lead fracture. The physician was advised to disable the patient's device, which she did later in the appointment. She was then told that if the patient were to continue therapy, his lead would likely need to be replaced. The physician noted that recent diagnostics performed were within normal limits, but she didn't have the results in front of her. On (b)(6) 2011, the patient's spouse requested information on the coverage for explanting the patient's device due to the need for an mri. The patient's wife said, they have decided not to replace the device due to a device malfunction, which she said was a fracture. She then went on to explain that prior to the high lead impedance, the patient was experiencing pain the neck and some visual issues where he couldn't see very well. The visual issues were later determined to be the result of a stroke so the patient needed to be referred for an mri, but her understanding was that because, he had an implantable device, he could not get one. Just the pain in the neck was thought to be related to vns, not the patient's stroke. The patient had been referred for multiple cat scans, which did not show a stroke so far; now the family wants the vns removed so they can do an mri. She was told that an mri could be performed, but there are specific precautions listed in our labeling. The wife then said that the vns id card said they couldn't do mris, but when asked to verify that the statement is present, she confirmed it was not. She then changed it to it was the physician who also said that an mri could not be performed, so she was informed that an mri is possible with certain limitations, as they are performed regularly by mri facilities. She was also told that the device can remain implanted and is not required to be removed, just disabled. Since the device has not been explanted and x-rays have not been received, a lead fracture has not been confirmed as the cause for the patient's high impedance. The patient's physician reported that the patient had gone to the emergency room for the pain in the neck and that a ct and an angiogram were performed which showed nothing abnormal. The physician does not know where the pain is related to vns or not. It is not known whether, the patient will have the device removed or replaced. The physician said that they will discuss it during the patient's next appointment; the specific date of the patient's next appointment was unknown. The physician said that after the patient returned from the hospital, the patient noticed that he wasn't having any voice alteration with stimulation. The patient was worried that his device wasn't working since he could not perceive any voice alteration. The physician does not think that the pain is associated with stimulation because, the patient could not be receiving stimulation due to the high impedance since the device may not be able to deliver the full current. The patient used to always have voice alteration with stimulation but it was not serious and no interventions were ever taken. The patient denied any trauma or fall that could have caused this. The physician could not provide any more settings or diagnostics. Additional information regarding the next steps the patient and physician were going to take for the patient's high impedance and pain was requested. The physician reported that x-rays were taken on (b)(6) 2011 and that they showed no anomalies. However the x-rays were not sent to the manufacturer for review. If additional information is received, it will be reported.

Manufacturer Narrative
Device failure is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2073724
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dennis100
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« Reply #103 on: March 18, 2018, 01:18:53 AM »

Model Number 102
Event Date 06/21/2011
Event Type Injury
Event Description
It was reported in clinic notes received on (b)(4) 2012 and dated (b)(4) 2011, where it was stated that the patient had cad (coronary artery disease). Additional clinic notes were received on (b)(4) 2012 and dated (b)(4) 2011 where it was stated that the patient had cad, cva (cerebral vascular accident - stroke) and cardiomyopathy. The generator was programmed to 2/30/130/60/3/2/250/60 and the patient was to follow up in six months. Good faith attempts to obtain additional information have been unsuccessful to date.

Event Description
Additional information was received on (b)(6) 2012 when the physician reported that the patient did not have a history of stroke or cardiomyopathy prior to being implanted with vns however he did not indicate a relationship between these events and the patient's vns device. Diagnostic results were provided which indicated normal device function however the date the diagnostics were performed was not provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2515621
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dennis100
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« Reply #104 on: April 14, 2018, 12:58:59 AM »

Model Number 300-20
Event Date 04/01/2012
Event Type  Malfunction   
Event Description
Additional information was received that the patient does not have any nerve damage. The patient's generator is coming up for replacement and it may be left off for a while. There is a possible lead issue that has not been confirmed at this time. X-rays were taken by their treating neurology office and no break was seen. They were not provided to the manufacturer for review. Their device will be programmed off till june and a treatment decision will be made after that time.
 
Event Description
Additional information was received that the patient had high lead impedance documented in a clinic not in (b)(6) 2012. Exact date of event unknown. At this time no revision surgery is planned as the patient had a history of having a stroke un vns related and from that has right vocal chord paralysis. They don't want to risk any damage to the left chord in revision surgery. Last april they averaged 0-1 month seizures. Their device was programmed off (b)(6) 2013. Their device was at or near eos at that time and their seizures are about the same. Their x-ray report says no lead break. The patient did not have a fall or injury that they know of preceding their high lead impedance.
 
Event Description
It was reported that a vns patient isuffered "laryngeal damage" due to his vns from a physician assistant. The patient is on a high duty cycle. The patient is scheduled for an ent consult in march and decisions for plan of care will be made after that time. It is unknown at this time when the event started. Good faith attempts thus far have been made and no further information has been attained.
 
Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2990022
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dennis100
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« Reply #105 on: May 14, 2018, 02:48:10 AM »

Event Date 06/29/2010
Event Type  Death   
Manufacturer Narrative
Although this particular report houses a death due to a specific type, no information is available on the cause of death of the corresponding patient, but this report will trace this specific death report to a known patient. (b)(4).
 
Manufacturer Narrative

Event Description
On (b)(6) 2013, the abstract for the article ¿major health issues in a cohort of epilepsy patients treated with vagus nerve stimulation therapy¿ was received and reviewed by the manufacturer. The following is the abstract for the article: rationale: vagus nerve stimulation (vns) is an adjunctive treatment for refractory epilepsy. Patients with vns typically have severe epilepsy and may have greater medical comorbidity than similarly aged cohorts. The vns device can complicate the management of comorbid conditions as some procedures are contraindicated by the device, or will require additional safeguards. To date, there have been few studies describing epilepsy sequelae and comorbidity in the vns treated patient population. This study aimed to identify major health issues in patients with refractory epilepsy treated with long-term vns. Methods: a retrospective analysis of major health issues, including significant medical issues and side effects, was performed in a cohort of 52 epilepsy patients treated with vns. Significant medical issues were defined as myocardial infarction, cerebrovascular accident, cancer, chronic pulmonary conditions, chronic gastrointestinal conditions, acute pulmonary events, acute gastrointestinal events, seizure-related injury, suicide attempt, and death. Results: the mean age at vns initiation and time of study was 39. 5 and 48. 3 years, respectively. Mean duration of therapy was 8. 9 years. Side effects limiting therapy were observed in 15. 4% of patients. At least one significant medical issue was seen in 38. 5% of patients. Death (19. 2%), seizure-related injury (15. 4%), chronic pulmonary conditions (11. 5%), and acute pulmonary events (9. 6%) were most commonly observed. Death occurred after a mean 8. 3 years of vns therapy at 54. 9 years of age, attributable to cancer in three (5. 7%) cases and likely to sudden unexpected death in epilepsy (sudep) in two (3. 8%) cases. Lack of follow-up limited vns management in 25. 0% of patients, representing an additional challenge in this population. The vns device mitigated medical management in five cases, including three cancers, one pulmonary, and one emergency surgery. Conclusions: while some illness may be anticipated due to aging and epilepsy refractory to treatment, comorbidity and mortality in this cohort were greater than expected. Consequently, knowledge of how vns impacts medical management in both acute care and outpatient settings is essential. Furthermore, medical comorbidity may have been under based on the number of patients in the study and the percentages provided, there were 10 deaths reported (two due to sudep, three due to cancer, and five from unknown cause), one patient who experienced an adverse event requiring emergency surgery, and one pulmonary event in which surgery could not occur. These events were reported on the following manufacturer reports: 1644487-2013-03741¿reports the 1st patient's death due to sudep, 1644487-2013-03742 ¿ reports the 2nd patient's death due to sudep, 1644487-2013-03743 ¿ reports the 3rd patient's death due to cancer, 1644487-2013-03744 ¿ reports the 4th patient's death due to cancer, 1644487-2013-03745 ¿ reports the 5th patient's death due to cancer, 1644487-2013-03746 ¿ reports the 6th patient's death (due to unknown reason), 1644487-2013-03747¿ reports the 7th patient's death (due to unknown reason), 1644487-2013-03748¿ reports the 8th patient's death (due to unknown reason), 1644487-2013-03749¿ reports the 9th patient's death (due to unknown reason), 1644487-2013-03750¿ reports the 10th patient's death patient (due to unknown reason) 1644487-2013-03751 - reports the patient with adverse event requiring emergency surgery 1644487-2013-03752¿ reports the patient with serious injury dyspnea [one pulmonary event in which surgery could not occur].
 
Event Description
Patient information has been received; however, no information has been received in which manner the patients passed away. The deaths were reported to not be related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3517630
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dennis100
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« Reply #106 on: July 06, 2018, 10:33:26 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 04/04/2018
Event Type  Injury   
Event Description
It was reported that a patient had a stroke following her vns implantation. It was further noted that the device was eventually turned on and that the patient is improving from the stroke. Device history records were reviewed for the implanted devices and both the lead and generator were sterilized and passed all quality inspections prior to distribution. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7572895
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dennis100
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« Reply #107 on: July 07, 2018, 04:40:04 AM »

Model Number 102R
Device Problem No Known Device Problem
Event Date 06/07/2018
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized due to a possible stroke. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7650998
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« Reply #108 on: July 14, 2018, 02:44:19 AM »

Model Number 102
Device Problem No Information
Event Date 01/15/2011
Event Type  Death   
Event Description
Cause of death information obtained from the (b)(6) index was reviewed by the manufacturer which indicated that the patient's cause of death was stroke, not specified as hemorrhage or infarction. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
Patient's lead and generator were received on (b)(6) 2016. The generator was unit was confirmed to be at end of service as result of normal battery depletion. The depletion was an expected event as determined by the battery life calculation and battery voltage measurement. A battery life estimation resulted in 0. 00 years remaining before the eri flag would be set. The module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portion. The lead assembly (body) including the electrodes was not returned for analysis; 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. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were 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.
 
Event Description
It was reported that the pt passed away. The cause of death, and the relationship to vns is currently unk. The devices will not be returned as they were not explanted after the pt passed away. Attempts for add'l info have been unsuccessful to date.
 
Event Description
A copy of the patient's death certificate was received on 01/17/2012. It was indicated that the cause of the patient's death was a cerebrovascular accident (cva). The patient passed away in a hospital. Attempts for additional information regarding the relationship of the cva to vns therapy have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2261532
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dennis100
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« Reply #109 on: October 03, 2018, 07:18:21 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/16/2018
Event Type  Injury   
Event Description
Additional information was received that the patient's vns was last checked in january and stated to be functioning normally. The physician's assessment of the patient's seizures, stroke and hospitalization was that it was unrelated to vns therapy,.
 
Manufacturer Narrative

Event Description
It was reported that the patient that he is currently in the hospital and they were told the battery was at 20% and needs to be changed. The patient was in the hospital due to uncontrolled seizures and stroke. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7770423
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dennis100
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« Reply #110 on: October 19, 2018, 11:54:55 AM »

Model Number 103
Event Date 01/01/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 were received on (b)(6) 2013. The notes indicated that the patient had canceled an appointment in the past where she was going to follow-up about numbness in the right side of the body. She was not able to attend that appointment because she was in the hospital, and it was believed that the patient had a stroke.
 
Event Description
Attempts for relevant information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3545751
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