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Author Topic: Misc. Cardiac  (Read 82817 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.
 
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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.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1276878
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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.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1229989
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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.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1030178
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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.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1053271
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dennis100
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« Reply #454 on: Today at 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.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1393198
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