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dennis100
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« Reply #90 on: March 04, 2016, 12:28:36 AM »

Event Type Injury
Event Description
It was reported that a vns patient is set to receive a right-side pacemaker implant for asystole. The doctor wanted to discuss the possible interactions between pacemakers and vns devices. It was reported that the patient initially had episode of bradycardia shortly after implant with vns system but it was initially not serious enough to require intervention. Now, the patient presents with asystole requiring intervention. It was reported by the physician that it is not certain if this patient's asystole is directly related to vns therapy. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5453334
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dennis100
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« Reply #91 on: May 04, 2016, 09:52:56 PM »

Model Number 103
Event Date 03/29/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a patient had laparoscopic nissun fundoplication surgery on (b)(6) 2016. Postoperatively, the patient was complicated by a seizure and then had cardioversion at 125j for arrhythmia. A ct scan was obtained, which showed a pericardial effusion. The patient was then emergency transported to another hospital for exploration surgery. During the surgery, it was determined that there was a hole in the pericardium and a tear in an arterial branch of the circumflex coronary artery. The vns magnet was placed over the device during this surgery. After the reparative surgery, the patient experienced recurrent episodes of painful stimulation, bradycardia, drop in blood pressure, and asystole during vns stimulation. The patient's magnet was placed over the generator, but, due to the patient being morbidly obese, the skin where the magnet was taped would move and allow stimulation to occur. The patient then had a temporary pacemaker implanted, and the vns was programmed to 0ma on (b)(6) 2016. Diagnostics were performed, and the results were all within normal limits. The arrhythmias and painful stimulation no longer occurred after the device was programmed off. The physician planned to leave the device programmed off for a while and slowly reintroduce therapy after the patient stabilized. It was also reported that the patient had a history of mild bradycardia prior to this event. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5598322
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dennis100
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« Reply #92 on: May 05, 2016, 05:16:20 AM »

Model Number 103
Event Date 03/01/2016
Event Type Injury
Event Description
It was reported on (b)(6) 2016 from a physician that the patient recently had a pacemaker implanted. The physician was calling to see what effect a pacemaker could have on the vns device. He was informed that the pacemaker is unlikely to have any effect on the vns. He was told that the pace maker could potentially sense the stimulation delivered by vns. The physician then reported that the patient is having some cardiac issues. He stated that he wanted the device to be programmed off to rule out the vns as the cause for the cardiac issues. The patient does not have a following physician for the vns. On (b)(6) 2016 it was stated that the patient was discharged that day and they are not sure what was making the patient hypotensive. Attempts have been made to the patient's last known neurologist but no relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5564271
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dennis100
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« Reply #93 on: December 09, 2016, 11:05:08 AM »

Model Number 106
Event Date 10/08/2016
Event Type Injury
Event Description
A report was received from the physician with additional information. The patient had a history of recurrent syncope and pre-existing medical conditions of seizure disorder and alcoholic encephalopathy. Rather than describing the heart stopping event as asystole as he previously did, in this report, the physician described it as bradycardia. He indicated in this report that a 12 seconds heart cessation event occurred, but described it as a pause of the heart rather than as the heart stopping as he previously did. Prior to the events, the patient's heart rate was within a normal range (in the 70 beats/ minute range). It was noted that no traumatic events occurred to the patient prior to the arrhythmia, nor were there any triggers or medication change that could have contributed. The arrhythmia did not correlate with the on time of the device and no device diagnostics or interrogation was performed. The only intervention taken was the hospitalization and the placement of a pacemaker on (b)(6) 2016. The generator is currently programmed on and the arrhythmia has not recurred as of (b)(6) 2016. No additional relevant information has been received to date.

Event Description
It was reported by the cardiologist that the patient presented with syncope. The patient was hospitalized. During the visit, the patient had 2 cases of asystole. The vns was reported to be disabled by the magnet. There were no more instances of asystole after disablement. However, the cardiologist could not say that the disablement stopped the asystole as a pacemaker was also implanted into the patient the next day. The patient was noted to have a history of severe autonomic dysfunction and encephalopathy. The cardiologist reported at a later date that he had seen the patient recently and she is doing fine. He believed that the vns was not the problem and did not contribute or cause the syncope or asystole; the patient simply had severe autonomic issues. However, the physician did not manage vns devices and was unaware of how the device functioned. No further relevant information has been received from the cardiologist to date. Attempts to contact the patient's follow up physician were made, but no relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6073121
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dennis100
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« Reply #94 on: March 02, 2017, 12:58:59 AM »

Model Number 102
Event Date 11/01/2010
Event Type Injury
Event Description
It was reported by a vns pt that she felt fast heartbeat in her chest, tightening in throat, difficulty breathing, and nausea when coming within 5-10 feet of a family member who had a pacemaker. Per manufacturer's labeling, pacemakers are not expected to affect the operation of vns system; however, it is recommended to keep a distance of 4 inches or 10 cm to avoid any interruption. The pt also stated that by holding her magnet over the vns device, the generator was disabled and her symptoms were alleviated. She was also concerned that the device may be malfunctioning due to trauma she experiences during her grand mal seizures; i. E. She falls down during her grand mal seizures. Lastly, pt complained about lack of efficacy of device that vns device has never stopped a seizure for her. Further follow up with the pt treating neurologist revealed that pt hasn't been seen since these adverse events were reported to the manufacturer. 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=1961088
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dennis100
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« Reply #95 on: May 06, 2017, 10:36:35 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 07/01/2016
Event Type Injury
Event Description
It was reported by the patient that he had been ¿going out¿ and that he wasn¿t sure if the vns was causing it. He said that he could also just be falling asleep, it could be a seizure or it could be his medication, but he was concerned that the vns and/or the vns and his pacemaker could be causing it. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6503540
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dennis100
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« Reply #96 on: May 18, 2017, 01:11:53 AM »

Model Number 102
Event Date 05/13/2008
Event Type  Malfunction   
Event Description 
Reporter indicated a vns pt was unable to be interrogated. The pt was recently implanted with the vns and vns diagnostics were normal during the surgery. Interrogation of the pt's vns was also unsuccessful by the mfr at an office visit. A surgery consult is planned for 2008. The pt also has a pacemaker.
 
Manufacturer Narrative 
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=1060001
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dennis100
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« Reply #97 on: October 12, 2017, 01:35:48 AM »

Model Number 102
Event Date 02/18/2013
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received from the neurologist that the patient's syncope could be related to complaint of frequent discharges from vns device. The patient was referred for generator replacement because of the syncope. No diagnostic test results or settings were provided. It is unknown if there were any other causal or contributory programming changes, medication changes, or other external factors precede the onset of the syncope.

Event Description
On (b)(6) 2013, it was reported that the vns patient has been feeling erratic stimulation that started about three weeks ago around (b)(6) 2013. There have not been any recent changes in parameter settings or medications. There also has not been any recent trauma or patient manipulation of the device. Diagnostics showed the device to be functioning properly. The patient was referred for generator replacement. A battery life calculation was performed which showed 4. 62 years remaining until eri=yes. It was reported that the patient underwent generator replacement on (b)(6) 2013, for prophylactic reasons. It was reported that the generator would be returned to the manufacturer for product analysis but it has not been received to date.

Event Description
Additional information was received on (b)(4) 2013 when product analysis was completed on the explanted generator. 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. The generator performed according to functional specifications; there were no anomalies found with the pulse generator.

Event Description
Additional information was received on (b)(6) 2013 when the explanted generator was returned for product analysis. Product analysis is still underway and has not yet been completed.

Event Description
The patient reported that she had experienced syncope episodes with the device and that the generator had been at end of service. The patient indicated that these syncope episodes also occurred when her packemaker died too; she also has a right sided pacemaker implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3033404
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dennis100
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« Reply #98 on: December 14, 2017, 03:55:19 AM »

Model Number 102
Event Type Injury
Manufacturer Narrative

Event Description
Attempts for additional information have been unsuccessful to date.

Event Description
A cardiac electrophysiologist called to inquire about precautions for placing a pacemaker in a vns patient. It was reported that the patient's neurologist suggested she get a pacemaker due to asystole; however, caller was unsure of the relationship of this to their vns. Good faith attempts are underway for further details about the reported event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3127018
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dennis100
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« Reply #99 on: December 23, 2017, 02:21:46 AM »

Model Number 106
Event Date 06/29/2016
Event Type Injury
Event Description
The patient's surgeon reported with a clinical assessment following the patient's vns and pacemaker implant procedures. The patient had an atrioventricular conduction block that was impacting cardiac function. The physician assessed that this was not related to vns. At the time of the follow up appointment on (b)(6) 2016, the patient's pulse rate and rhythm were assessed to be normal. No additional pertinent information has been received to date.

Event Description
It was reported that the patient started having several bradycardia and asystole events soon after a full vns replacement surgery. The patient was admitted to the hospital in relation to these events. The vns generator was confirmed to have been enabled after the replacement surgery. There were no cardiac issues noted during the implant or testing. Post-operative diagnostics were reported to be within normal limits. The vns magnet was placed over the device to inhibit stimulation and the cardiac events did not resolve. The treating physician concluded that the cardiac events were not related to vns stimulation. The relation between the cardiac events and vns surgery has not been clarified to date. The patient was subsequently evaluated for a pacemaker implant, and the case was completed. Attempts for additional pertinent information have been unsuccessful to date.

Manufacturer Narrative
(b)(4).

Manufacturer Narrative
(b)(4). Initial report inadvertently listed wrong expiration date. Initial report inadvertently listed wrong device manufacture date. Initial report inadvertently listed wrong udi.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5817715
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dennis100
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« Reply #100 on: December 26, 2017, 03:05:39 AM »

Model Number 102
Event Date 01/20/2014
Event Type Injury
Event Description
It was reported that the recently implanted vns patient was seen for their first follow up appointment with the neurologist on (b)(6) 2014 where the device was programmed on for the first time. The patient returned home and subsequently began experiencing chest pain and went to the emergency room where the patient was diagnosed with heart block. A cardiologist referred the patient for pacemaker implant surgery. Although the cardiologist stated that the patient¿s heart block diagnosis was not related to vns, the neurologist continued to inquiry about a possible relationship between heart block and vns. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3679922
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dennis100
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« Reply #101 on: March 06, 2018, 03:55:55 AM »

Model Number 302-20
Event Date 03/29/2012
Event Type Malfunction
Event Description
Analysis of the vns generator was completed. No anomalies were identified, and the generator performed per specifications.

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

Event Description
Reporter indicated a patient had vns lead and generator replacement surgery due to a lead fracture noted in the area of the pulse generator during surgery. The patient was having surgery because she also had a cardiac pacemaker present which was causing interference with the vns, and vns diagnostics were unable to be performed. The pacemaker was repositioned and the patient had a new vns generator and lead implanted. Diagnostics with the new vns system were within normal limits. The patient had a pacemaker implanted in (b)(6) 2011 due to bradycardia which was unrelated to the vns. The explanted lead and generator were returned for analysis with paperwork indicating a lead fracture was present and the vns did not prevent seizures after pacemaker placement. Analysis of the lead did not identify any anomalies. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis of the generator is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2554875
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dennis100
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« Reply #102 on: May 04, 2018, 01:58:16 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 07/16/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported via social media comment on a forum post that the patient experienced bradycardia six days following implant, two weeks following that, and several years after that. The patient reported passing out, shortness of breath, and not being able to stay awake. Her heart rate was stated to be in the 20s and while in the hospital, she had to disable the vns using the magnet. The patient stated that when the vns stimulated every five minutes, her heart rate would drop. With the magnet disablement, she stated that her heart rate return to normal. The patient was worried about getting the vns removed as it had been working for her seizures. The patient had a pacemaker recently implanted. It was previously reported that the patient experienced fainting and dizziness that the medical professional attributed to very high doses of the patient's medications, which resolved when the patient stopped taking the high doses. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7468305
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dennis100
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« Reply #103 on: May 05, 2018, 01:30:09 AM »

Model Number 102
Event Date 03/28/2011
Event Type  Injury   
Event Description
It was reported that the vns pt has been experiencing 3rd degree av heart block and bradycardia. The physician has stated that the pt has been hospitalized and will likely need a pacemaker. The physician has stated that the arrhythmia occurs even when vns stimulation has been disabled. The physician still feels however, that there may be a partial relationship of the vns stimulation to the arrhythmias. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2082984
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dennis100
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« Reply #104 on: May 24, 2018, 01:12:58 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 04/04/2006
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
A patient reported periodic bradycardia approximately 3 weeks after implant surgery. The arrhythmia reportedly was not present prior to vns implant; however, vns had not been turned on at the time the arrhythmia was first identified. The patient was evaluated by a cardiologist, who determined that the events were not related to vns, but to her neurological medications since the vns had not been enabled. The patient was given a cardiac work-up, which came back negative. The neurologist noted that the patient's heart rate was in the high 30s and she was also experiencing hypotension (blood pressure 70/30) and syncope. The patient had been hospitalized for these issues, which the physician reported began prior to stimulation being enabled. The neurologist reported that the vns was programmed to low settings to evaluate the patient's response to stimulation and mitigate the frequency of the bradycardia episodes in the event that they occurred with stimulation. The patient's heart rate reportedly increased by 8-10 beats per minute during stimulation. Impedance was within the normal limits. A company representative reported that the patient had a preexisting pulmonary embolus, which required clearance prior to vns implantation. The surgeon later evaluated the patient and reported that the bradycardia did not appear to occur with stimulation. The surgeon reported that he implanted the vns electrodes below the cardiac branches of the vagus nerve. The generator had been turned off several weeks after the initial occurrence of bradycardia, and the surgeon did not believe that the bradycardia was related to vns as the bradycardia did not stop after stimulation had been disabled. Over a decade after the initial report of bradycardia, the patient reported to the manufacturer that her vns caused her to go to the er constantly with severe chest pain and arrhythmias. The patient reported that her blood pressure and heart rate would plummet, nearly requiring the use of a pacemaker. The patient reported using a magnet to relieve some of the pain, but much of it persisted. She also reported experiencing an increase in seizures. The patient was in intensive care often due to the reported events. The patient eventually underwent vns lead and generator explant surgery. The patient reported that the arrhythmias resolved after explant, but a bundle block remained. The patient reportedly still experienced problems trouble regulating her heart rate and blood pressure. The manufacturer's database of programming history was reviewed for the patient's generator. Diagnostics performed on the date of implant confirmed proper device function. A significant portion of the programming history was unavailable for review; however, stimulation was observed to be enabled at a clinic visit 10 months after implant. The vns was then programmed off. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7372277

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dennis100
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« Reply #105 on: May 27, 2018, 12:53:30 AM »

Model Number 102
Event Date 03/21/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, clinic notes from a vns treating physician's assistant were received by the manufacturer. Review of the clinic notes dated (b)(6) 2012 revealed that the vns patient has a pacemaker. The clinic notes did not state the type of arrhythmia the patient was experiencing nor the relationship of the event to vns. Good faith attempts for further information were made to the patient's cardiologist but no additional information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2545757
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dennis100
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« Reply #106 on: June 06, 2018, 02:01:31 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 #107 on: August 11, 2018, 01:41:21 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that the patient had a defibrillator put in. The patient was having atrial fibrillation. The neurologist didn't think the vns was the cause of the atrial fibrillation and thought the patient had atrial fibrillation before being implanted with vns. A cardiologist though wanted the device disabled. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7726058
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dennis100
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« Reply #108 on: October 03, 2018, 07:30:20 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/10/2018
Event Type  Injury   
Event Description
A research article hypothesized the risk factors to determine a relationship between vns and clinically-significant arrhythmias. The case study central to the article discussed a patient who was admitted to the facility with symptomatic bradycardia associated with vns stimulation. The patient's medical history was reviewed. It was noted that the patient did not exhibit heart rate changes related to vns stimulation during the vns implant procedure; however, 3 years after implant, the patient occasionally exhibited loss of consciousness initially presumed to be related to a change in seizure type. It was later determined that the patient experienced momentary bradycardia, av block, and a brief cardiac arrest during sleep. The patient was implanted with a cardiac pacemaker, which resolved the bradycardia. Previous literature was also reviewed in the context of this article. The literature review identified 21 patients documented across 14 studies exhibited arrhythmias presumably induced by vns. Several of these events are discussed in the following mfr. Report #s: 1644487-2014-01653, 1644487-2006-00148, 1644487-2008-01907, 1644487-2008-01792, 1644487-2008-01919, 1644487-2009-01201, 1644487-2008-01648, 1644487-2008-03112, 1644487-2009-02887, 1644487-2011-01081, 1644487-2011-01081, 1644487-2012-02233, 1644487-2012-00993.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7779058
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« Reply #109 on: July 06, 2019, 12:14:00 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/30/2005
Event Type  Injury   
Manufacturer Narrative
 
Event Description
The patient reported that during their first vns surgery they flat lined on the operating table. It was also noted that the patient flat lined again during a different surgery when their pacemaker was placed. The patient mentioned that they may have bad reactions to the anesthesia and thinks that this may have caused the flat line events, however they are not sure what the true cause was. A review of device history records for the generator confirmed that no unresolved non-conformances were found. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8684204
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