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Author Topic: Bradycardia/Hypotension  (Read 103343 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 »

Model Number 102
Event Date 01/01/2013
Event Type  Injury   
Event Description
Additional information was received that the physician could neither rule out or rule in vns as the cause of the bradycardia. However there is not any indicated for the that vns is causing the issue. No former information was provided.
 
Event Description
It was initially reported that the patient was hospitalized for bradycardia. No further information was provided and the relationship to vns is unknown. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3357735
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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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