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dennis100
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« Reply #30 on: March 28, 2018, 12:15:53 AM »

Model Number 104
Event Date 05/20/2011
Event Type Injury
Event Description
It was reported by a nurse at the hosp epilepsy monitoring unit that the pt "has asystole, and not seizures" and want to remove the pt's vns and implant a pacemaker. It is unk if there is any relationship between the asystole and the vns. The vns was reportedly disabled and it is unk if the vns generator and/or lead have been explanted at this time. Attempts for further info have been unsuccessful to date. Attempts to the pt's previous neurologist found that he has not been seen in some time and no longer sees that physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2139241
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dennis100
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« Reply #31 on: March 28, 2018, 12:16:38 AM »

Event Date 01/01/2008
Event Type Injury
Event Description
Reporter indicated that an asystole event had occurred. No other information is available at this time. All attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1222464
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dennis100
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« Reply #32 on: March 28, 2018, 12:17:58 AM »

Model Number 104
Event Date 10/18/2012
Event Type Injury
Event Description
It was reported that a patient, who recently had his vns replaced, was seen for follow up with the physician as he had started falling down abruptly on 11/7/2012. It was reported that shortly after hitting the floor would be fully coherent knowing exactly what happened. These were not seizures according to the nurse. Diagnostics were performed and were within normal limits, 2394ohms. At that time, the patient's settings were decreased. On (b)(6) 2012, the patient was sent to the er and admitted to the heart monitoring unit. After monitoring for a while with the generator on the saw repeated events of bradycardia and short duration asystole. It was unclear if these events were occurring with stimulation on times. Late in the evening on (b)(6) 2012 they shut off the vns to 0 ma. From the evening of (b)(6) 2012 until the initial report on (b)(6) 2012, they had not observed any more events. They are monitoring home now and plan to turn the vns back on at a low setting and continue heart monitoring to determine if the vns has a direct correlation to the heart events that are occurring. No additional information has been provided to date, however, it was indicated that an update would be provided when it was determined if the bradycardia and short duration asystole corresponded to stimulation. During the report, it was also noted that the patient experienced the same event when he was initially implanted. This is reported under manufacturer's report number: 1644487-2012-03360.

Manufacturer Narrative

Event Description
On (b)(6)2013, the abstract of the article "asystole caused by a vagal nerve stimulator for epilepsy. Heart rhythm. " was received. It was confirmed with the physicians that the patient referenced in the article was the same one reported on the initial medical device report. The article reports that the patient has a history of intractable seizures since childhood and was admitted to a cardiac intensive care unit for evaluation or recurrent syncope. In 1998, the patient had a vns placed in an attempt at better seizure control. After battery change two weeks prior to admission, he experienced several ¿drop attacks¿ that consisted of brief periods of non- responsiveness without postictal confusion, much different than his typical seizure. His baseline ecg was normal. During eeg monitoring, seizure activity was noted, but it was also shown that the patient was having asystole related to the vagal nerve stimulation. A subsequent holter monitor showed multiple episodes of asystole up to 15 seconds long associated with syncope. The patient's vns device was then deactivated following which there was complete resolution of asystolic episodes on continuous ecg monitoring. His syncopal episodes have not returned. The conclusion of the article states that ventricular asystole has mainly been reported as a rare complication intraoperatively during the implantation of the vns. This case demonstrates that such serious events may still occur years after implantation of the device. Per the article, it is a very rare complication, but it is possible that syncope secondary to a vns device might be mistaken for seizures.

Event Description
Additional information was received which indicated that both the bradycardia and asystole that the patient was experiencing are believed to be related to vns stimulation. This was confirmed through eeg monitoring and monitoring the cardiac unit. The patient experienced asystole ranging from about seven seconds to about 14 seconds while monitored. The patient's settings were output current: 1. 75ma, frequency: 30hz, pulse width: 500usec, on time: 30sec, off time: 3min, magnet output: 2. 5ma, magnet on time: 60sec, magnet pulse width: 500usec at this time. When the device was disabled, all cardiac events subsided. The nurse did not have much medical history on the patient, so she was unable to comment on if the patient had bradycardia or asystole prior to vns. Additionally, the clinic declined filling out the arrhythmia questionnaire for additional information. It was noted that this was the patient's fourth generator. The patient experienced no cardiac issues with the first two generators; however, the issues began with the third generator, though they were not as frequent. Following the fourth generator implant, the issues became severe enough to go to the clinic. It was uncertain if there were any programming changes which led to the event and diagnostics were not performed. Additionally, when the patient's device was turned back on briefly, the patient experienced coughing with stimulation at 0. 5ma which resolved within the week. The generator has been programmed off and will likely remain off, despite the parent's wishes as the patient has experienced efficacy with the device. The physicians are recommending alternate forms of treatment; however it is unclear at this time if the system will be explanted. The ambulation difficulties were a result of the cardiac issues. No additional information has been provided.

Manufacturer Narrative
Date of event, corrected data: per additional information, the onset of the event began prior to what was initially reported in the initial mdr.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2874462
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dennis100
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« Reply #33 on: March 28, 2018, 12:19:31 AM »

Event Date 01/01/2000
Event Type Injury
Event Description
It was reported in an article reviewed by manufacturer that the vns patient experienced an asystole event and was subsequently explanted. Attempts to obtain additional information are underway.

Manufacturer Narrative
Andriola mr, rosenweig t, vlay s. "vagus nerve stimulation (vns): induction of asystole during implantations with subsequent successful stimulation. " epilepsia 2000;41(suppl. 7):223.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1102479
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dennis100
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« Reply #34 on: March 28, 2018, 12:20:33 AM »

Model Number 103
Event Date 12/14/2012
Event Type Injury
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 #35 on: March 28, 2018, 12:22:11 AM »

Model Number 103
Event Date 03/26/2013
Event Type Injury
Manufacturer Narrative

Event Description
A vns consultant was asked to go to a local hospital and check a patient's device. The patient was in the hospital and the patient had his magnet taped over the device. She was told that if they remove the magnet the patient has asystole with stimulation. The patient's device was not checked as they did not want to have an asystole occur. Good faith attempts are underway for further details.
Manufacturer Narrative

Event Description
External cardiac defibrillator paddles were used on patient in the er and also had a ct scan. Asystole started/noted in er when admitted. He has a condition called wolff-parkinson-white syndrome and has had arrhythmias associated with that. There for no prior recent vns programming changes prior to events. System diagnostic testing performed in icu: 1410 ohms/ok. Device programmed to zero output current/zero magnet output current (b)(6) 2013. In er/icu - events were believed by the attending physicians to be attributed to vns stimulation and occurred during stimulation but did not occur when the magnet was in place over the generator. The patient's treating neurologist did not believe these events were due to vns and will be following the patient until further assessment takes place. The attending physicians did believe the vns was contributing to their cardiac events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3067719
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dennis100
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« Reply #36 on: March 28, 2018, 12:24:02 AM »

Model Number 102
Event Date 05/01/2006
Event Type Injury
Event Description
A cardiologist called and asked for labeling on the vns and cardioversion. She had a patient who had a vns implanted, hospitalized in icu that was in afib and she needed to cardiovert them before putting a pacemaker in. The patient was having cardiac pauses as well and she did not think it was related but was not sure. Actual start date of event unknown. Said that it occurred during the off time so that she did not think so. She said that the patient was elderly so most likely related to that but could not be 100% sure. It was asked if she had tried to disable the device to rule out the vns and she said no, since she was not having it during the on time. She felt that she did not need to do that and that it was most likely related to her age. Patient was set to 7 secs on time 3 mins off time. The patient had sick sinus syndrome with severe bradycardia requiring their pacemaker placement (b)(6) 2006 in the right chest area. No interactions with their vns were reported. During this time frame, the patient was also found to have paroxysmal atrial fibrillation and was placed on coumadin. After implant with their pacemaker, the vns device and pacemaker are reportedly were working well and the patient doing fine as well. The patient had been implanted since (b)(6) 2005, and there is no indication that this event coincides with vns stimulation. No further information will be provided in regards to their cardiac event from their physician's office. It was later reported in (b)(4) 2013 that the patient had died. (b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2972148
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dennis100
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« Reply #37 on: March 28, 2018, 12:25:00 AM »

Model Number 103
Event Date 12/09/2013
Event Type Injury
Manufacturer Narrative

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.

Event Description
Additional information was received that vns system was last checked on (b)(6) 2015 resulting in output status ok, lead impedance ok with impedance value of 2032 ohms. It was reported that patient has modest response to vns therapy. Magnet stimulation can abort seizures if swiped close to the onset. No cardiac issues noted during routine vns clinic appointments. Physician reported that previous bradycardia events for the patient occurred in relation to use of lacosamide drug and remitted when lacosamide was stopped. Review of manufacturing records confirmed all tests passed for the device prior to distribution. Attempts for additional relevant information about the asystole events 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 #38 on: March 28, 2018, 02:13:16 AM »

Model Number 103
Event Date 03/29/2016
Event Type Injury
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.

Event Description
Data was received from 03/29/2016 and 03/30/2016. No anomalies were noted - the data indicated that the device was functioning within normal limits. It was observed that the impedance had dropped from 2674 ohms to 1419 ohms (-47. 0% change) on (b)(6) 2016, 5:57:24 (estimated). The sudden temporary drop in impedance could be attributed to the nerve¿s response to injury (i. E. Expel of ionic endoneurial fluids from damaged nerve cells; an observed increase in this fluid via mri is often used as an indicator of nerve injury). It was found that electrical current from the external defibrillator (cardioversion equipment) can transfer through the generator and leads to the vagus nerve, where the resulting charge density and energy delivered to the nerve from the defibrillation is at levels considerably higher than what the nerve experiences with vns therapy, even at maximal settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5598322
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dennis100
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« Reply #39 on: March 28, 2018, 02:14:11 AM »

Model Number 103
Event Date 12/25/2012
Event Type Death
Manufacturer Narrative

Event Description
Hold. Ng 1/2/13. The reporter indicated that a vns patient was admitted to the hospital on (b)(6) 2012 due to seizures, where the patient later exhibited additional adverse events which included asystole, bradycardia, aspiration, and coughing. The patient latter died on (b)(6) 2012 at 4am in the hospital due to cardiac arrest, and the death was witnessed. X-rays reviewed by the manufacturer on (b)(6) 2013 noted no anomalies. The reporter later stated that the coughing and aspiration were related to pneumonia, and that the increase in seizures was related to the fact that the patient is known for "periodic flurries of seizures. " after the patient was hospitalized the vns was disabled using the magnet, and bradycardia recovery was noted. The reporter also stated that the patient had four heart attacks before the vns was implanted. The concurrent illnesses/diseases include pneumonia, developmental delay, heart attacks (x4), stroke, lung cancer, cerebral palsy, absent corpus callosum, and mental retardation. It was not known to the reporter if the vns was explanted after death. It is not known if an autopsy was performed. The reporter stated that he tried to obtain information from the hospital staff that regarding the patient's condition, but they did not respond. The physician stated that the patient was very ill who was in his 20's with a "5 year-old body", and had bad seizures, no corpus callosum, suffered a stroke and had a peg tube all before the vns was implanted. The patient's medications were changed on (b)(6)2012 to compensate for the vns being disabled with the magnet. Per the reporter, the relationship of the death to the vns is unknown.

Event Description
New information was received indicating that the implanted vns products were not explanted prior to the funeral.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2930248
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dennis100
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« Reply #40 on: March 28, 2018, 02:14:49 AM »

Model Number 104
Event Date 06/01/2011
Event Type Injury
Event Description
Reporter indicated a vns pt had experienced syncope and hypotension events, and had experienced an episode of asystole while hospitalized for spinal fusion surgery. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2166843
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dennis100
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« Reply #41 on: March 28, 2018, 02:16:15 AM »

Model Number 102R
Event Date 04/13/2011
Event Type Injury
Event Description
Additional information was received. The full article was provided. This case report is a case of a (b)(6) man with intellectual disability who about 8 years later developed an iatrogenic ventricular asystole presenting as recurrent cardiogenic syncope following vns which was initially misdiagnosed as his seizure worsening. His vns workup did not reveal any cardiac problems. His vns was fitted following usual procedures. The required intraoperative tests were performed and no complications were noted. Following his vns being fitted his seizure frequency and intensity of both seizure types improved significantly. Approximately 8 years later there was an increase in what seemed to be atonic seizures which started occurring on an almost daily basis, which given his history. Were considered to be his seizure worsening. The aed treatment he was on at the time which included levetiracetam 3000 mg/day and pregabalin 300 mg/day were adjusted and his vns was checked and titrated but there was no improvement in his seizures. A detailed description of these events suggested that these attacks were different from previous episodes and pointed at a cardiac cause. An assessment of his cardiac status was then requested. There was suspicion that the vns was causing symptomatic bradycardia and a 24 hr cardiac monitor was arranged. It showed recurrent episodes of recurrent ventricular standstills, pauses and runs of complete heart block. At this point the vns was deactivated. A repeat cardiac monitor show sinus rhythm throughout. Approx 2 months after vns was deactivated his seizures worsened despite aed treatment. Following another discussion with family, his family made a decision to reactivate the vns again, approx 4 mo after it was disabled. Vns was turned on at lower settings than previous unfortunately sustained recurrent syncope returned with confirmation on the cardiac monitor. The vns was again turned off. The patient remained deactivated after this. Article sites (b)(6) article described a case report of interoperative bradycardia and asystole ((b)(4)/medwatch report number 1644487-2008-01907) another event addressed in file (b)(4) medwatch report number:1644487-2008-03112.

Manufacturer Narrative
(b)(4).

Event Description
Reporter indicated the vns generator was disabled due to asystole occurring with vns stimulation. The vns stimulation was lowered to 0. 75ma, but the patient again experienced asystole, so the vns was disabled. The reporter has declined to provide additional information at this time.

Manufacturer Narrative
Corrected data: the correct patient age is provided. Only the birth year was provided by the reporter. Suspect medical device: the correct device information is provided per the reporter. Implant date, corrected data: the correct implant date is provided. Device manufacture date, corrected data: the correct manufacturing date is provided.

Event Description
It was reported to our country manager in (b)(6) that they had a vns pt implanted with a model 101 which has been implanted for 9 yrs, and is an extremely good vns responder. Over the past 6 months, the pt had reported to his general practitioner that they were having "odd" turns, which their physician initially attributed to focal seizures. However the pt had a cardiological review also, and the ecg showed that he was having 12 second pauses at the time of stimulation. On =30secs, off = 3 mins, so every 3 mins, there was a 12 second pause. The cardiologist contacted our country rep to ask her to switch the device off but unfortunately, the pt had recently left (b)(6) for a six week holiday in (b)(6). The nurse is attempting to make contact through family members to contact the pt and find a vns treating physician in (b)(6). There is also a query as to whether the pt could have a cardiac pacemaker implanted alongside their vns, because they do not want him to lose his therapy. The pt does not have a medical history of this prevns implantation. Once the pt returns from their vacation they will be admitted to hospital for some cardiac monitoring to plan the next course of action. If further info is attained another report will be sent.

Event Description
Additional details were provided by the reporter, including the correct vns implant information. The plan of care is to keep the vns disabled for now. The vns was disabled on (b)(6) 2011.

Event Description
Additional information was received from an abstract that was discussing this patient's event. Reported that vns is a treatment option in patients with refractory epilepsy unsuitable for other surgical options. Vns helps in intractable cases with an average decrease in seizure frequency by 40%. It involves an operation to implant under the skin a generator with coils wrapped around the left vagus. Vns is well tolerated and safe though there have been cases reported of bradycardia occurring intraoperatively and clinically. Parasympathetic hyper stimulation of the right vagus predisposes to bradycardia. The left vagus when hyper stimulated predisposes to atrioventricular (av) blocks. There has been no cases that we are aware of reporting av blocks post vns. We report a case of iatrogenic ventricular asystole presenting as drop attacks following vns which initially was misdiagnosed as seizure worsening. A (b)(6) man with intellectual disability and treatment resistant intractable epilepsy (generalised seizures including drop attacks) had a vns fitted. There were no intraoperative complications. The vns workup did not reveal any pre cardiac problems. His seizures improved. Two years later there was an idiopathic increase in drop attacks which was, given his past seizure history considered to be seizure worsening. There was no improvement to anti-epileptic medication and vns titration leading to a review of his cardiac status. A 24hr ecg showed recurrent episodes of ventricular standstills, pauses and runs of complete heart block corresponding with vns stimulation. No other cause could be found to explain this occurrence. Vns was turned off. Subsequent ecg was unremarkable. Two months later all forms of his epilepsy worsened prompting a patient choice of switching on the vns under 24hr ecg monitoring. The ecg after switch on showed continued p wave activities but runs of ventricular asystole after vns stimulation. The longest asystole was 9. 79 seconds. This led to the vns being turned off again. The abstract reported that the vns is considered a safe option in epilepsy management. Unfortunately it can cause side effects of iatrogenic asystole and misdiagnosis of seizure worsening. Awareness of this rare but late onset, life threatening side effect of vns is important.

Manufacturer Narrative
Case report: vagal nerve stimulation and late onset asystole. Rhit shankar, victor oluwaseyi olotu, nicholas cole, heather sullivan, caryn jory. Seizure 2012 jan 2 pii:s1059-1311(12200332-9. Doi 10. 1016/j. Seizure 2012. 12. 011.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2096034
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dennis100
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« Reply #42 on: March 28, 2018, 02:17:17 AM »

Model Number 106
Event Date 06/29/2016
Event Type Injury
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.

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5817715
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« Reply #43 on: March 28, 2018, 02:18:00 AM »

Model Number 103
Event Date 05/01/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient suffered asystole. The physician reported that the patient was diagnosed with takotsubo syndrome which caused the patient to suffer asystole in early may. The relationship of the asystole and vns is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3942289
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« Reply #44 on: March 28, 2018, 02:19:02 AM »

Model Number 102R
Event Date 07/01/1998
Event Type Injury
Event Description
Additional information was received which indicated the patient did not experience any bradycardia or asystole with the initial implant, but in fact experienced these events with the third implant. It was noted that the events were not very frequent. The bradycardia and asystole were determined to be related to vns stimulation. It was unknown if the patient had a medical history of bradycardia and asystole prior to vns implant. It was uncertain if there were any programming changes which led to the event, and no diagnostic history was provided. No additional information was provided. The device was explanted on (b)(6) 2012 due to the battery being at end of service. The explant had no relation to the bradycardia and asystole events.

Manufacturer Narrative
Age at time of event, corrected data: per additional information, it was found that the patient's age listed in the initial mdr was incorrect as the event date is unknown. Date of event, corrected data: per additional information, it was found that the date listed in the initial mdr was incorrect as the event date is unknown. Model, serial #, lot #, expiration date: per additional information, it was found that the incorrect device was reported on the initial mdr. Device manufacture date (mo/day/yr): based on the device reported in this supplemental mdr, the incorrect manufacture date was used in the initial mdr.

Manufacturer Narrative

Event Description
During the report of bradycardia and asystole captured in manufacturer's report number: 1644487-2012-03359, the patient's mother indicated that the patient had experienced a similar event when he was initially implanted. This report captures the possible arrhythmia which occurred when the patient was initially implanted. No further information is known at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2874466
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« Reply #45 on: March 28, 2018, 02:19:45 AM »

Model Number 102
Event Date 01/01/2011
Event Type Injury
Event Description
It was reported by a cardiologist that the patient was experiencing asystolic episodes. The physician is not sure if it is related to the vns. Per the patient, the vns has ben turned off for some time, but the physician could not confirm this as he is not a vns physician. The physician is not exactly sure when symptoms first began, but they have recently become worse. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2063787
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« Reply #46 on: March 28, 2018, 02:20:39 AM »

Event Date 01/01/2007
Event Type Injury
Manufacturer Narrative
De herdt v et al. , "vagus nerve stimulation for refractory status epilepticus," european journal of paediatric neurology (2008), doi: 10. 1016/j. Ejpn. 2008. 05. 004.

Event Description
An article reported that a vns pt experienced increasing episodes of bradycardia and low blood pressure on days 3 and 4 after initial implant of the vns device. The output current was increased, and on day 4 after the implant surgery, an acute episode of asystole occurred. The output current was then decreased. The article indicated that intraoperative device testing had been without implications. It was noticed, however, that prior to the surgery, the pt had a high vagal sensitivity when aspirating or repositioning the tube. The cardiac function of the pt was already compromised by thiopenthal coma, and other sedative medication and her poor clinical condition. A combination of these factors, and vns may have enhanced the episode of asystole. Despite the occurrence of asystole, vns was never aborted. 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=1096446
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dennis100
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« Reply #47 on: March 28, 2018, 02:21:31 AM »

Model Number 102
Event Date 08/01/2011
Event Type Injury
Manufacturer Narrative

Event Description
It was initially reported that patient had been having recent arrhythmia events. She had been having some atrial fibrillation, which was being treated with medication. Then the patient began having asystole events that last about 6 seconds and well as some bradycardia. The patient had an emergency pacemaker placed and then underwent surgery to have a pacemaker implanted. The relationship of the cardiac events to vns is unknown. Good faith attempt with both the neurologist and the cardiologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2261210
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« Reply #48 on: March 29, 2018, 01:42:17 AM »

Event Date 11/27/2013
Event Type Injury
Manufacturer Narrative

Event Description
A maude event report ((b)(4)) was received indicating that the patient was found unresponsive with a heart rate of 16 bpm. It was reported that the patient was hospitalized and intubated and that the patient was released several days later. It was also noted that the patient has experienced an increase in seizures for the past few months and that the seizures are different than prior seizures. It was reported that the patient no longer experiences her usual aura and no post-ictal state. It was reported that vns induced asystole/bradycardia is suspected. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3651797
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dennis100
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« Reply #49 on: April 06, 2018, 06:34:35 AM »

Model Number 1000
Device Problem No Known Device Problem
Event Date 02/27/2018
Event Type  Injury   
Event Description
It was reported that during a generator replacement surgery the patient experienced asystole shortly after system diagnostics were performed on the newly implanted generator. The device was programmed to the patient's previous settings and the patient was fine in the recovery room. The next day the patient was admitted to the hospital with periodic asystole and associated bradycardia. The generator was programmed off. The patient was then admitted to the cardiac floor at the hospital and the neurosurgeon requested the device be turned back on. The device's normal output current was titrated up and it was noted that the patient experienced arrhythmia with stimulation. The generator was programmed off. The generator was subsequently replaced due to the arrhythmia events. The explanted generator has been received. Product analysis is underway but has not been completed to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7365899
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dennis100
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« Reply #50 on: April 21, 2018, 01:43:27 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 #51 on: April 22, 2018, 01:34:14 AM »

Event Date 01/01/2012
Event Type  Injury   
Manufacturer Narrative
Ryzi m, brazdil m, novak z, chrastina j, oslejskova h, rektor i, et al. Long-term vagus nerve stimulation in children with focal epilepsy. Acta neurol scand. 2012. http://Http://www. Ncbi. Nlm. Nih. Gov/pubmed/22994298.
 
Event Description
An article entitled ¿long-term vagus nerve stimulation in children with focal epilepsy¿ was received. The article reviewed one and two year efficacies of 15 patients implanted with a therapy system. Of the 15 patients, 7 were responders at one year after implant, nine were responders at two years after implant, and nine were responders at five years after implant. Initial settings were provided. The output current was increased in two week increments of 0. 25 ma to a target intensity of 01. 50 ma to 2. 0 ma depending on efficacy and the presence of side effects. Rapid cycles (on time: 3. 0 seconds, off time: 1. 8 minutes and on time: 7 seconds, off time: 18 seconds) was used in all patients who were classified as non-responder at one year. Medications were kept unchanged during the first six months. The article concluded that vagus nerve stimulation is an effective method of treating children with refractory focal epilepsy. It led to a substantial decrease in the number and duration of urgent hospitalizations. The article indicated that one patient experienced severe adverse effects requiring explant of the device. The patient experienced repetitive attacks of cardiac asystolia, sometimes associated with syncope at the time when the device was switched on. The syncopes started after more than one year of stimulation. The asystole was strictly related to the on status of the device and was not related to patient seizures. ¿ this was provided by video-eeg monitoring. The patient did not response to vns; therefore, the output current was not adjusted. The discontinuation of vns led to the complete cessation of these symptoms. The cardiological investigations performed on this patient both pre-operatively and post-operatively (during the off times) revealed no abnormalities. Other severe adverse effects were not observed. The explant due to cardiac events is captured in mfr report #1644487-2013-01439. Urgent hospitalizations were also reported for nine patients in the post-operative period. This was defined as hospitalization because of an increase in seizure frequency with a change or adjustment in the long-term aed treatment or because of an adverse event, a complication of the epilepsy itself, or an aed treatment that lead to any permanent therapeutic treatments. This report captures the urgent hospitalization for an increase in seizure frequency for patient 5 of 9. Additional reports are captured in mfr report #1644487-2013-01490, mfr report #1644487-2013-01491, mfr report #1644487-2013-01493, mfr report # 1644487-2013-01494, mfr report #1644487-2013-01496, mfr report #1644487-2013-01497, mfr report #1644487-2013-01498, mfr report #1644487-2013-01499 the article also noted that cough, hoarseness, and mild dysphagia were observed in 12 of the 15 patients reviewed. In none of these patient¿s was the severe effect a reason for discontinuation of vns, and the effect resolved completed by the next visit.
 
Event Description
Additional information was received that all of the reported adverse events (except for the cardiac event) were mild, temporary, and overall in line with the experience.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3122253
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dennis100
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« Reply #52 on: May 16, 2018, 03:19:23 AM »

Model Number 102
Event Date 01/11/2008
Event Type  Injury  
Event Description
Reporter indicated that a vns patient was experiencing 30 second periods of heart block associated with stimulation on times and subsequent arrhythmias. The patient has a prior history of syncope and heart rate irregularities. Diagnostic testing showed the device to be functioning properly. Ekg strips were evaluated and showed that the patient was experiencing a ventricular standstill. The device was programmed off.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=992788
« Last Edit: May 16, 2018, 05:43:04 AM by dennis100 » Logged
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« Reply #53 on: May 18, 2018, 07:05:36 AM »

Model Number 103
Event Date 09/06/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Attempts for additional information have been unsuccessful to date.
 
Event Description
It was reported by a physician that the patient was experiencing bradycardia while monitored telemetry machine. The bradycardia was occurring every 1. 8minutes. The magnet was taped over the device and left for twelve hours. Upon removal of the magnet, the patient experience asystole. The heart rhythm was regained when the magnet was placed back over the device. Attempts for additional information are in progress.
 
Event Description
It was reported that the patient's output current was titrated down, and eventually reached a level where the patient was no longer experiencing bradycardia.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2772615
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