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Author Topic: Misc. Cardiac  (Read 89654 times)
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dennis100
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« Reply #450 on: May 19, 2017, 01:21:12 AM »

Model Number 101
Event Date 12/04/2008
Event Type  Injury   
Event Description 
It was reported in a scientific article that a vns patient, who had been receiving vns therapy for nine years without complaint, was admitted to the hospital for the control of an episode status epilepticus, an event not uncommon for the patient, for which medication was administered. The patient experienced an increase in seizures during the hospital stay and eeg monitoring revealed the occurrence of periodic cardiac changes with bradyarrhythmia and often severe asystolia due to atrium ventricular block, which coincided with stimulation. The patient was admitted to the cardiac intensive care unit and underwent holter monitorization, because the periodicity of the bradyarrhythmias was the same as that of the ncp stimulation (around 30 s every 5. 5 min), the ncp was stopped. Once the device was disabled, the reported arrhythmia event resolved. The reporter states that though there appears to be a clear relationship to vns therapy, other contributing factors were believed to be present. These factors include the addition of levetiracetam, which had a notable arrhythmic effect on the patient. The author also suggests that the patient's status episode may have predisposed the patient to the vns-related cardiac arrhythmia.
 
Manufacturer Narrative 
Article citation: iriarte, jorge, elena urrestarazu, manuel alegre, alfonso macias, asier gomez, paola amaro, julio artieda, and cesar viteri. "late-onset periodic asystolia during vagus nerve stimulation. " epilepsia 49 (2008): 1-5.
 
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dennis100
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« Reply #451 on: May 20, 2017, 08:22:48 AM »

Model Number 102
Event Date 07/01/2008
Event Type  Injury   
Event Description 
The initial reporter indicated "that ever since getting vns, she was on the lowest setting because it caused mania". The initial reporter spent the night in the emergency room and per the emergency doctor, she reported he stated "that it was over stimulating her heart and brain. So, they turned it off. " good faith attempts have been made to the patient's vns treating physician and thus far, no additional information has been attained.
 
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dennis100
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« Reply #452 on: May 23, 2017, 01:51:59 AM »

Model Number 102
Event Date 12/01/2007
Event Type  Injury   
Event Description 
Initial rptr indicated that the pt was seen in the er due to chest pain. Reported "started with persistent chest pain about 2 mos ago, prior to her last study visit in 2008. She also started with more intense localized stomach pain and nausea about the same time - she pointed to an area just below her sternum. " the pt has been prescribed medication for her stomach pain. The pt's "eeg and stress test and other heart-related tests have been within normal limits. " reported she had 2 heart scans the 2nd one "showed something". The pt immediately had an angiogram which was negative. Her chest pain is reported to be worse with stimulation and she also has the sensation of a lump in her throat with stimulation. Additionally reported the sensation of wheezing progressing from throat to her chest, with stimulation and has difficulty swallowing when stimulation is on. Since she has been experiencing these events she has been having difficulty sleeping. The vns was disabled for a week to see if the events would resolve. The pt saw a cardiologist and her heart testing was within normal limits. The cardiologist, therefore, concluded that the pt's symptoms must be caused by the vns stimulation. It was reported the pt did not want to consider an adjustment of parameters at this time, and she is considering having the device explanted. Her symptoms/side effects resolved when the device was turned off. The pt is unstable mentally at this time and she is voluntarily being admitted for psychiatric care. The pt's mental state is not over her pre vns events of depression, but being increased by the vns side effect issues she is having. No date set at this time for the pt to have their vns explanted.
 
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dennis100
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« Reply #453 on: May 24, 2017, 02:28:13 AM »

Event Date 04/27/2008
Event Type  Injury   
Event Description 
Reporter indicated a pt's vns was disabled due to constant voice hoarseness and difficulties swallowing which had not resolved despite programming changes. Four days after the vns was disabled, the pt developed an elevated blood pressure and had dizziness. No pathological reason for the elevated blood pressure or dizziness has been found. Attempts for further information from the attending physician have been unsuccessful to date.
 
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dennis100
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« Reply #454 on: May 27, 2017, 02:07:51 AM »

Model Number 102
Event Date 07/06/2006
Event Type  Injury   
Event Description 
A vns patient indicated that he was experiencing dizzy spells which prompted him to visit the emergency room. In the emergency room, an ekg was performed and the results indicated a normal sinus rhythm without stimulation and sinus arrhythmia with occasional premature ventricular complexes during stimulation. It was also indicated that the patient may have possible left atrial enlargement. The patient's device was subsequently disabled with his magnet reportedly causing him to slip "back into depression again. " the patient did indicate that he has a pre-existing history of bradycardia and that he wears a pulse oximeter monitor to alert him when "it hits 39. " follow-up with the patient's cardiac surgeon, who had performed a cardiac exam a month after the patient's initial report, revealed that the patient showed no evidence of arrhythmia or heart enlargement. The patient indicated that he received surgical consult from another cardiac surgeon who reportedly did not diagnose him with any "major" heart condition. Later the patient indicated that he had failed a stress test and that his condition has "gotten to be severe bradycardia". The patient is now seeking surgical consult for the implant of a pacemaker. Good faith attempts for additional information have been unsuccessful to date.
 
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dennis100
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« Reply #455 on: June 09, 2017, 07:51:26 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 09/01/2016
Event Type Injury
Event Description
It was reported that the patient was informed by her cardiologist that she did not need vns, so she stopped seeing her neurologist to manage her device. The patient's device reportedly depleted around (b)(6) 2016, and the patient had an increase in seizures. The patient went back to her neurologist and was referred for generator replacement surgery, as the neurologist believed that the vns was necessary. A battery life calculation did not support that the patient's device would have been depleted at that time. Attempts for further information were unsuccessful to date. A blc was performed, which resulted in 3. 8 years until neos=yes. The last known settings were from (b)(6) 2012: 1. 75ma/20hz/250us/30sec/3min.

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dennis100
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« Reply #456 on: June 09, 2017, 07:52:15 AM »

Model Number 102R
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type Injury
Event Description
It was reported by the cardiac physician's assistant that they wanted someone to interrogate and possibly disable the patient's generator to see if it was affecting the patient's heart rate. The pa indicated that the patient was bradycardic, typically with a heart rate in the 40s, but it had dropped down to the 30s with a junctional rhythm. The patient had been bradycardic for the past several months but it had worsened and she had presented at the er with dizziness and lightheadedness. The patient had a history of coronary heart disease and had a heart attack less than a year prior. The patient was described as having a complicated medical history. No further relevant information has been received to date.

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dennis100
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« Reply #457 on: June 10, 2017, 02:00:55 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 06/19/2014
Event Type Death
Manufacturer Narrative

Event Description
It was reported that a patient passed away. The patient's neurologist reported that the patient's death was not believed to be related to vns as the physician believed the patient had a heart condition. The physician did not know of the patient's cause of death as he recently learned of the patient's death. The patient was last seen 3 months prior to his death and was not having any problems with the vns device when he was last in the physician's office. No settings or diagnostics were available from the last time the patient was seen. The patient's death certificate did not indicate a cause of death, but indicated that the patient died at his place of residence. An autopsy was performed, but results of the autopsy have not been received to date. The patient's death is classified as probable sudep. No additional relevant information has been provided to date.

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dennis100
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« Reply #458 on: June 10, 2017, 02:01:56 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 03/29/2017
Event Type Injury
Event Description
It was reported by that patient underwent a cardioversion procedure. Following the procedure the patient¿s generator pocket appeared infected and the skin around the generator was breaking down which caused the generator to extrude. The physician was concerned that the cardioversion procedure could have contributed to the generator extrusion. The patient was referred for surgery due to the generator extruding from the body. The patient's generator was explanted and no replacement occurred at that time. A manufacturing review was performed which showed the generator and lead were sterilized prior to distribution. No additional relevant information has been received to date.

Manufacturer Narrative
Device evaluation is not necessary because the reported event have been determined as not related to vns therapy, but rather to the presence of the device.

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dennis100
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« Reply #459 on: July 06, 2017, 02:20:37 AM »

Model Number 102
Event Date 01/01/2010
Event Type Injury
Event Description
It was reported that the pt was experiencing dizziness, headache, and decreased blood pressure with stimulation. The device was disabled which resolved the events. Per physician, the events are believed to be related to the vns. Attempts for further info have been unsuccessful to date.

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dennis100
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« Reply #460 on: July 07, 2017, 11:30:36 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 08/01/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The physician reported that the patient had experienced respiratory arrest and had undergone cardiac massage. During this procedure, it is suspected that the generator had migrated and was no longer in the pocket. The patient has reported about not feeling the stimulation and increasing depression since the chest procedure. However, the physician clarified that the patient reports feeling stimulation every once in a while, but not as much as before. Based on good diagnostic test results, it was explained to the physician that the device is functioning as intended and that the patient could have become acclimatized to the sensation at the current settings. It was recommended that the output current could be increased to the next level. No additional relevant information has been received to date.

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dennis100
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« Reply #461 on: July 13, 2017, 03:59:16 AM »

Model Number 102
Event Date 04/04/2011
Event Type  Injury   
Event Description
It was reported by a vns pt that after she allergic reaction to antibiotics prescribed by neurosurgeon, captured in mdr# 1644487-2011-00975, she was told by hospital physician that she has an abnormal ekg. She was referred to cardiologist but the name of cardiologist was not provided. Good faith attempts to obtain additional information from pt's neurologist have been unsuccessful to date.

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dennis100
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« Reply #462 on: July 15, 2017, 01:51:00 AM »

Model Number 102
Event Date 03/09/2012
Event Type  Injury   
Event Description
It was reported on (b)(6) 2012 that the vns patient was going to be implanted with a cardiac recorder device. Additionally it was reported that the patient is pre-syncopal likely due to atrial fibrillation. Attempts to obtain additional information have been unsuccessful to date. At this time it is unknown what is the relation of the arrhythmia to vns.

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dennis100
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« Reply #463 on: July 15, 2017, 01:51:41 AM »

Model Number 102R
Event Date 09/01/2013
Event Type  Injury   
Event Description
The vns patient inquired whether or not vns therapy could cause an irregular heartbeat after receiving therapy for a while. The patient was informed that verification would be needed by a cardiologist. The patient reported that he was given a stress test and that the cardiologist informed him that he has an irregular heartbeat and that he needed to follow-up with his neurologist regarding this issue. The relationship of the irregular heartbeat to vns is unknown. Attempts to obtain additional information have been unsuccessful to date.

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