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Author Topic: Bradycardia/Hypotension  (Read 131343 times)
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dennis100
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« Reply #270 on: August 10, 2017, 07:51:50 AM »

Model Number 102
Event Date 08/01/2011
Event Type  Injury   
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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dennis100
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« Reply #271 on: September 06, 2017, 01:44:33 AM »

Event Date 11/27/2013
Event Type  Injury   
Event Description
Patient found unresponsive with heart rate of 16 - was hospitalized and intubated; released after several days; patient noted to have increased seizures for the past few months - seizures are different from prior seizures in that she sometimes just drops to the floor without her usual aura and no post-ictal state. Suspect vns-induced asystole/bradycardia.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3502109
« Last Edit: May 14, 2018, 08:41:28 AM by dennis100 » Logged
dennis100
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« Reply #272 on: September 08, 2017, 02:50:24 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 08/01/2017
Event Type  Injury   
Event Description
It was reported that a vns patient was experiencing bradycardia and left chest pain. It was not known if the bradycardia is related to vns, but the physician hasn't ruled it out yet. The vns was disabled due to these events, and the pain and bradycardia both continued after the disablement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6821272
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dennis100
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« Reply #273 on: September 08, 2017, 11:40:48 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 07/14/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
Medical staff noted that a patient's heart rate was below 40 beats per minute, per the patient. The patient and medical team were unsure if the patient's bradycardia was related to vns. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6775196
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dennis100
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« Reply #274 on: October 06, 2017, 02:50:14 AM »

Model Number 106
Device Problem No Known Device Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing chest pressure intermittently that the nurse practitioner stated is "probably timed to the activation of the vns. " the patient also had a holter monitor that showed bradycardia however the relationship of the bradycardia to the vns device is unknown. The nurse stated they had performed x-rays however the x-rays have not been reviewed by the manufacturer to date. It was stated that if the adverse events were bad enough the settings might be reduced at the next clinic visit. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6889387
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dennis100
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« Reply #275 on: November 29, 2017, 02:02:53 AM »

Model Number 103
Event Date 08/25/2015
Event Type Injury
Event Description
It was reported that the vns patient experienced bradycardia with a possible 10 second asystole event that occurred when performing system diagnostics on (b)(6) 2015. Radial and brachial pules were nonpalpable and heart rate was non-audible during this 10 second period. The patient suddenly slumped in his chair and was unresponsive. The physician attributed the asystole event to vns stimulation. The patient's heartbeat prior to the suspected asystole event was 56 bpm. The patient did not display any symptoms and did not experience any traumatic events leading up to the event. No changes to device settings or medications preceded the onset of the event. Before performing system diagnostics, x-rays were taken and were reported by the physician to be unremarkable. The device was subsequently disabled. The patient did not have a prior history of cardiac events. The patient underwent a 14-day holter monitoring period on (b)(6) 2013 which was reported by the physician to be unremarkable. The patient was admitted to the hospital and evaluated by the emergency department to preclude a serious injury to the patient. The event has not reoccurred and the patient has been doing well following the event. System diagnostic results showed lead impedance within normal limits. It was noted that the patient had been experiencing painful stimulation for 12-24 hours prior to the asystole event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5092187
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dennis100
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« Reply #276 on: December 05, 2017, 02:50:43 AM »

Model Number 102R
Event Date 02/01/2015
Event Type Injury
Event Description
It was reported that a vns patient had vagal episodes from (b)(6) 2015 and persisted for 6 months. The device parameters were not changed. It was reported that during that period, the patient was in a clinic study (trial) from (b)(6) 2015. But due to high discomfort, she stopped it in (b)(6) 2015. It was reported that those discomforts included especially dizziness with nausea, sometimes accompanied by blurred vision and pallor, without loss of consciousness. It was reported that when a cardiologist saw the patient in (b)(6) 2015 for a clinic examination / ecg / abpm, the patient showed a sudden hypotension (70-80 systolic) without symptoms reported above. The patient was again seen by the cardiologist in (b)(6) 2015, who indicated that everything was fine. It was reported that the patient was initially implanted with vns in 2002, and then replaced in 2010. No patient adverse events were reported during that period before (b)(6) 2015. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5245961
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dennis100
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« Reply #277 on: December 27, 2017, 02:27:23 AM »

Model Number 106
Event Date 08/26/2016
Event Type Injury
Event Description
It was reported that a patient was in the hospital due to an increase in seizures and bradycardia. It was suggested that they use the magnet to disable the patient's device until the patient could be seen by their treating physician to disable the device. Information was received on 09/06/2016 that the patient was continuing to have bradycardia and seizures, which the medical staff at the hospital believed to be related to vns. It was again suggested that they use the magnet to disable the device until the treating physician could communicate with the device. The patient's vns magnet was used to disable the patient's device on (b)(6) 2016. Diagnostics were also performed on the patient's device, and it was functioning properly. The bradycardia was reported to be intermittent, but it was unknown if it was correlated with vns stimulations. The patient's anti-seizure medication, vimpat, was also discontinued on (b)(6) 2016, and the bradycardia and seizures appeared to have stopped. It was unknown at that time if the bradycardia and seizures were related to vns or not. The treating physician recommended that the patient's device be programmed off. However, the attending physician decided not to turn off the patient's device to prevent the risk of the patient experiencing an increase in seizures, but instead decided to tape the patient's magnet over the device again. Using the magnet to disable the device the first time was reported to not have an affect the bradycardia, but the physician decided to try it again just in case. Information received on 09/22/2016 indicated that the increase in seizures and bradycardia were suspected to be related to the patient's vns, but the physician was not positive. The device was still being disabled using the magnet, and the seizures stopped and bradycardia got better. However, the bradycardia was still present. There were no other planned interventions regarding his vns at that time. No further relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5975334
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dennis100
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« Reply #278 on: December 28, 2017, 03:42:55 AM »

Model Number 104
Event Date 06/01/2014
Event Type Injury
Event Description
An article titled ¿vagus nerve stimulation and late-onset bradycardia¿ by the patient¿s treating physician reported that 1 year and 11 months post-implantation, the patient experienced recurrent syncope, associated with lightheadedness, difficulty breathing, and complete loss of consciousness, lasting up to 10 seconds. His stimulation parameters were unchanged for five months prior to syncope, and there were no preceding medication changes. Immediately before hospitalization, the patient¿s caregiver observed heart rate in the 40s during his syncope, occurring every 3-4 minutes. Similar observation of bradycardia on cardiac rhythm strip was seen, with vns stimulation felt by the patient. He had sinus bradycardia, with heart rate of low 30s, which instantaneously resolved when the vns was deactivated. When diagnostic testing was attempted, he had immediate syncope after vns was reactivated, associated with sinus bradycardia and asystole. Thus, vns was again deactivated, without any further bradycardia or syncope. X-ray ruled out lead breakage. Cardiologist had recommended placement of temporary transvenous pacemaker backup when testing the integrity of the vns and its effect on cardiac conduction system and blood pressure, but the patient and his family chose to leave the vns deactivated. One month after vns deactivation, a 48-hour holter monitor showed normal heart rate and rhythm. A transthoracic echocardiogram at four months was normal. There was a great concern for worsening of his convulsion, but after six months, his seizure frequency had remained stable, without any convulsion. Cardiac and metabolic causes were ruled out. The patient had no prior history of cardiac problems. The physician notes that the limitation of this report is the absence of device diagnostics, to ensure device proper functioning. The brady-arrythmia was most likely related to vns, but the ultimate cause remained unclear to the physician. Anatomic variation of vagus nerve innervation of the heart could not be ruled out. However, the physician noted that this would be a more likely explanation if symptom onset was seen earlier, during or closely after initial device placement or generator replacement.

Event Description
It was reported that while the patient was with his wife in the hospital he began experiencing syncope and was seen in the emergency department. It was noted that the syncope and bradycardia the patient was experiencing was in sync with device stimulation. The magnet was placed over the device and the patient improved. The patient's magnet was removed and the patient became pale and had a syncopal episode. The device was programmed off and the patient was seen by a cardiologist. The cardiologist believes that the patient may have an underlying cardiac issue that has contributed to the bradycardia and sycope. It was reported that the plan is to place a pacemaker. The patient's mother reported that the patient's heartrate increased with the device programmed off. The physician reported that the patient will undergo pacemaker implant. Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Manufacturer Narrative

Event Description
During the event, the patient¿s heart rate dropped to the low 30s and experienced asystole for a few seconds. There were no traumatic events or medication changes prior to the events. The neurologist believed that the arrhythmia was possibly related to vns stimulation and believed that vns exacerbated or co-currently contributed to the arrhythmia. In the opinion of the medical professionals treating the patient at the time of the events, the bradycardia and asystole were felt to be related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3907270
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dennis100
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« Reply #279 on: December 29, 2017, 02:31:17 AM »

Event Date 01/01/1996
Event Type Injury
Manufacturer Narrative
Han p, frei mg, osorio i. Probable mechanisms of action of vagus nerve stimulation in humans with epilepsy: is a window into the brain [abstract]? epilepsia 1996;37 (5suppl):83s.

Event Description
It was reported in an article reviewed by manufacturer that vns patients are experiencing bradycardia and tachycardia with stimulation. A decrease in r-r variability is sometimes seen in patients at risk of sudden cardiac death. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1143661
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dennis100
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« Reply #280 on: January 04, 2018, 02:41:09 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/25/2017
Event Type Death
Event Description
Follow-up from the hospital where the patient expired provided that the patient presented to the er from hospice. She presented with respiratory distress. She was experiencing respiratory difficulty which was new for her and she was complaining of chest pain that had a bradycardia episode, developing to a heart attack. The patient declined into respiratory failure, agonal respirations, and eventually cardiopulmonary arrest.

Event Description
It was reported by a physician that a vns patient was deceased. The patient passed away at a hospital, and was a resident of a group home facility. An online obituary found the patient had died (b)(6) 2017. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6362787
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dennis100
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« Reply #281 on: January 08, 2018, 03:09:19 AM »

Model Number 102
Event Date 05/01/2011
Event Type Injury
Event Description
It was initially reported that the patient was referred to cardiology after going to the emergency room due to sinus bradycardia. The reporter believed that the device may be causing the problem. Diagnostic results from the time of the event were not available. No additional information is available at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2160854
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dennis100
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« Reply #282 on: January 12, 2018, 02:39:27 AM »

Device Problem No Known Device Problem
Event Date 10/01/2017
Event Type Malfunction
Manufacturer Narrative
Balasubramanian k, harikumar k, nagaraj n, sandipan p. 2017. Vagus nerve stimulation modulates complexity of heart rate variability differently during sleep and wakefulness. Annals of indian academy of neurology. 20:403-407. (b)(4).

Event Description
It was reported via article received by the manufacturer that the patient experience vocal cord paralysis due to the vns surgery. It was also stated that the patient experienced recurrent episodes of syncope and dizziness as well as an aberrant activation of the cardiac parasympathetic system contributing to bradycardia and subclinical seizures. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7155717
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dennis100
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« Reply #283 on: January 12, 2018, 02:40:15 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 12/04/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was hospitalized due to bronchitis. While in the hospital it was noted that the patient also had bradycardia that was associated with vns stimulation. Additional information as received that the bradycardia was confirmed to have been associated with the vns stimulation based on timing and that it was asymptomatic. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7155480
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dennis100
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« Reply #284 on: February 01, 2018, 04:33:24 AM »

Model Number 102R
Device Problem No Known Device Problem
Event Date 01/04/2017
Event Type Injury
Event Description
Additional information was received from the physician stating the vns is currently off and it was explained that the noted "underlying current cardiac issue" was bradycardia. The physician noted the bradycardia resolved after the vns was programmed off as the patient's heart rate increased from the 40s to the 60s (in regards to beats per minute). The physician explained he will further evaluate the patient after all testing and lab work has been reviewed; however, as of now, the patient's vns remains off.

Event Description
It was reported by the patient's physician that the patient had been admitted to the hospital for dizzy spells and an associated fall. While in the hospital, it was noted the patient was experiencing periods of bradycardia, with his heart rate remaining around 40 beats per minute. It was requested that the vns be programmed off to rule out any interference with the patient's current cardiac issues. It was also reported that the patient's cardiologist planned to monitor the patient's cardiac status over the next 24 hours. This patient is currently implanted with his 5th vns generator and he was originally implanted on (b)(6) 1998. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6284939
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dennis100
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« Reply #285 on: February 01, 2018, 07:55:02 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported the patient has been experiencing unusual bradycardia. The patient¿s regular heart rate is 78-90 bpm, but goes down pretty rapidly to 45-48 bpm for a few seconds. It first occurred a few weeks ago and the caregivers did not think anything of it. It then kept occurring, but didn¿t coincide with vns stimulation. It happened about 20 times in a day. It was noted the magnet was swiped and no bradycardia occurred that day. It was noted the patient also wears a smart vest that goes on the patient¿s chest and gives a pulsating massage to loosen phlegm in his throat. It is unknown if this has any influence in regards to the reported bradycardia. It was noted at the patient's appointment the device diagnostics were 3100 ohms, which is within normal limits. It was later explained the physician does believe the vns is at least partly responsible for the patient¿s bradycardia. The low heart rate was intermittent, but when it did happen, it would occur at 5 minute intervals, which corresponded to the vns on and off time for normal mode. The physician did not think the events were related to any medications; however, he did request the family see a cardiologist as he thinks there may be an underlying cardiac issue and the vns just happened to bring attention to it. The patient was not having bradycardia as part of his seizures. It was noted the output current was reduced for autostimulation, normal mode stimulation, and magnet mode stimulation to attempt to resolve the bradycardia. It was noted the bradycardia only occurred during sleep and was not persistent or symptomatic. Some sleep periods would show heart rate drops while others would be unaffected with no clear pattern. When the patient¿s heart rate did drop, it would quickly go from the 60s-70s to 35-45 and then return to baseline within 3-5 seconds. The family had observed this on at least one occasion which led them to tape the magnet over the device to inhibit stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6274989
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dennis100
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« Reply #286 on: February 09, 2018, 04:04:51 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 09/11/2017
Event Type Injury
Event Description
Patient's caregiver reported that the patient's heart rate was in the upper 40s range and mentioned that this occurred when magnet was swiped. This was mentioned briefly but was not confirmed. During the next clinic visit, the caregiver reported bradycardia with heart rate in the range of 30 to 50 bpm. The physician mentioned that the caregiver saw that but that she is not sure how it was measured. During the patient's clinic visits, the heart rate had been 65, 65 and 63 bpm for the past three visits. But as the bradycardia may be related to vns, the physician decided to decrease the frequency of the settings. Diagnostics were normal and there were no warning messages. The caregiver was asked to take patient to a cardiologist and get holter monitor to check on the bradycardia. The physician did not know if this was done to date. A few days later the caregiver reported that the patient was agitated, angry, & being aggressive and associated it to the setting change. The physician did not think the behavior issue was related to vns or the frequency change as the patient has had behavior issues even prior to vns therapy. As the caregiver was particular about changing the settings, the frequency was adjusted again to 25 hz. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7201460
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dennis100
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« Reply #287 on: February 09, 2018, 04:51:46 AM »

Device Problem No Known Device Problem
Event Date 12/20/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a patient who had bronchitis did not tolerate vns stimulation well due to bradycardia occurring for the patient during stimulation on times. It was noticed during an eeg for the patient that the bradycardia occurred exactly every 3 and a half minutes which corresponded with the vns on time. It was advised to decrease the pulse width and frequency however it is not known if these changes were made. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7187658
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dennis100
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« Reply #288 on: March 09, 2018, 09:41:05 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 01/24/2018
Event Type Injury
Event Description
During a patient's emergency room visit for seizures and status epilepticus, it was noted that when the vns magnet was swiped, the patient's heart rate would decrease from 70 bpm to 32-35 approximately 10-15 seconds after a magnet swipe. The heart rate decreases were also accompanied by shortness of breath. The reporter noted that the vns was working to stop his seizures. Follow-up with the treating physician indicated that the patient's heart rate changed from approximately 80 bpm to 1 bpm, as caught on a cardiac monitor. Dilantin was being administered via iv when the bradycardia occurred, but the physician reported that the patient did not demonstrate any other symptoms or experience any traumatic events prior to the arrhythmia. The patient did not have a previous history of arrhythmia. The physician believed that the bradycardia was related to vns stimulation and exacerbated by magnet swipes. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7281269
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dennis100
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« Reply #289 on: March 09, 2018, 01:27:15 PM »

Device Problem No Known Device Problem
Event Type Injury
Manufacturer Narrative

Event Description
It was reported the patient had experienced bradycardia with high settings that was resolved when settings were lowered. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7266941
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dennis100
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« Reply #290 on: March 20, 2018, 01:58:15 AM »

Model Number 103
Event Date 09/06/2012
Event Type Injury
Event Description
Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative

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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« Reply #291 on: April 06, 2018, 02:15:27 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 04/04/2006
Event Type  Injury   
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.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7372277
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dennis100
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« Reply #292 on: April 06, 2018, 06:33:18 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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« Reply #293 on: April 07, 2018, 01:48:50 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 01/26/2018
Event Type  Injury   
Event Description
Report received that a pain had pain that radiated from her generator site to her neck, face, and right side of her head. This pain was reportedly worse upon exertion but also occurred while sitting. The pain had reportedly occurred for three weeks with a few severe episodes. The patient also reported feeling fatigued. The patient reportedly went to the hospital during one severe painful experience where cardiac work was done. Although the results were negative, there was reportedly some bradycardia. The physician reported that the vns was checked and the settings were "low". The impedance was also reportedly checked and was found to be within normal limits. The physician elected to disable the device but indicated he would refer the patient for follow-up with a surgeon for reevaluation of other etiologies. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7352997
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dennis100
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« Reply #294 on: May 01, 2018, 02:00:34 AM »

Model Number 102
Event Date 10/01/2008
Event Type  Other   
Event Description
My son has microcephaly with spastic quadriplegia. He is nonverbal and requires total care. He had increased seizure activity while in the hospital for spinal rod placement, and his vagal nerve stimulator was "turned up" to try and help with this. He went home uneventful and in fact a day early and had 2 more visits to the neuro for adjustment of the vns. By approx two months later, pt developed severe breathing problems, erratic heart rates 45-152/min, loss of his voice when he cried and profuse sweating. He ended up requiring constant nasal oxygen with a nonrebreather at times. He now also requires cpap at night and daily breathing treatments. I taped the magnet onto the vns the following month to shut it off, because his doctor didn't believe it was the vns. If i hadn't of done this, my son would be dead today. I am a rn and am appalled at the lack of caring and knowledge r/t this device. I took him back to the surgeon that put it in and he turned the device down to the original settings. At the highest point, it was on for 30 sec and off for. 8 min with 2. 5 amp. It is now on for 30 sec and off for 5 min at 1. 75 amp. Dates of use: 2007 -- 2008. Diagnosis or reason for use: seizures. Event abated after use stopped: yes. Event reappeared after reintroduction: no.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1276206
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dennis100
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« Reply #295 on: May 04, 2018, 01:56:54 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 #296 on: May 05, 2018, 01:27:27 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 03/21/2018
Event Type  Injury   
Event Description
It was reported that the patient had a prophylactic full revision surgery and experienced post-operative bradycardia that appeared to be a result of stimulation on times. The surgeon programmed the device off. There were no issues observed during the surgery or intraoperative bradycardia. The impedance during the surgery was within normal limits. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7445894
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dennis100
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« Reply #297 on: May 30, 2018, 04:15:03 AM »

Model Number 102
Event Date 01/01/2012
Event Type  Injury   
Manufacturer Narrative
Date of event; corrected data: the previously submitted mdr inadvertently provided an incorrect event date.
 
Event Description
Further information was received via an article titled "late-onset periodic bradycardia during vagus nerve stimulation in a pediatric patient. A new case and review of the literature", published on 02/26/2016. It was reported that 7 years after vns implantation ((b)(6) 2012), the patient suddenly began to have new attacks with sudden falls and loss of consciousness lasting less than 10 sec, which were similar to her previous drop-attacks but preceded by dizziness. It was reported that the ecg showed a normal sinus rhythm with a heart rate of 90 bpm(beats per minute). But during vns magnet activation (output current of 1. 25 ma) the heart rate slowed down to 45 bpm. The bradycardia duration was a few seconds longer than the stimulation period (30 sec). The same response was elicited with magnet vns activation with an output current of 0. 50 ma. The heart rate was not significantly altered when the output current was 0. 25 ma. It was reported that the device was switched off on (b)(6) 2013. It was reported that vns stimulation parameters had not been changed for the latest years prior to the reported adverse effect (30sec on time; 5min off time; 1. 25ma output current; 20hz frequency; 250 sec pulse width). It was reported that during the following week the patient did not reveal any presyncopal spells, and she was sent home. Abnormal placement of electrodes was ruled out by radiography. As reported in the article, a correlation between vns stimulation and cardiac arrhythmia was evident with vns magnet activation during ecg recording. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012.
 
Event Description
It was reported by a company representative that a patient was in the hospital due to a syncope episode. The patient was detected with two bradycardia episodes in the moment of stimulation along with a new syncope episode while at the hospital. The patient's vns parameters were lowered due to the reported events. At the moment the cause of the reported events and their relationship to vns is unknown as good faith attempts to obtain further information from the treating physician regarding the reported events have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2538414
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dennis100
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« Reply #298 on: June 07, 2018, 12:45:18 AM »

Model Number 103
Event Date 09/01/2010
Event Type  Injury   
Event Description
It was initially reported by the nurse that the pt has been experiencing some cardiac issues recently. Pt was implanted in 2009, and the events started a month ago. Pt had an ekg prior to vns implant and everything was ok but the ekg after vns, the pt has been experiencing bradycardia with 36 bpm. Pt did not have any medication changes or other reasons that could have been underlying causes. Nurse did not believe that there were any problems with the vns. Good faith attempts to obtain additional info has been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1905378

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dennis100
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« Reply #299 on: June 13, 2018, 09:05:53 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 06/09/2017
Event Type  Injury   
Event Description
It was reported that when a vns patient¿s device is on it had an effect of av node block. Systems diagnostics were reported to be fine. The physician lowered the stimulation on time in the hope of resolving it. The physician then turned the device off and that resolved the symptoms. When the device was turned back on the problem returned. A holter monitor was used and seems to confirm that when vns is on there's a cardiac response. The device was left off to see what happens. Additional relevant information has not been received to-date.
 
Event Description
Follow-up to the treating provider indicated the patient is doing ok.
 
Event Description
Follow-up from the provider indicated the vns is believed to be causing the cardiac symptoms. The specific effect of the av node block was bradycardia as the patient¿s heartrate went down to 30 beats per minute. The patient was placed on an ekg/event monitor and was referred to cardiology. They dynamically adjusted the vns parameters guided by the ekg.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6685430
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