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Author Topic: Misc. Cardiac  (Read 7219 times)
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dennis100
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« Reply #300 on: October 11, 2018, 07:00:15 AM »

Model Number 103
Event Date 05/15/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, a pacemaker company representative reported that the vns patient will be having a pacemaker implanted due to sick sinus syndrome. It was unknown when the event first started. Good faith attempts were made to the physician for further information but no additional information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2602866
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dennis100
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« Reply #301 on: October 12, 2018, 04:53:01 PM »

Model Number 101
Device Problem Insufficient Information
Event Date 06/23/2012
Event Type  Death   
Event Description
Cause of death information obtained from the (b)(6) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2012 and the patient's cause of death was acute myocardial infarction (unspecified), atherosclerotic heart disease, and heart failure (unspecified). There is no allegation or other information indicating that the death is related to vns.
 
Event Description
It was reported that a vns patient was going to be referred for generator replacement surgery. The patient died prior to their surgery consult. No information is known surrounding the cause of their death or the circumstances around their death. Their neurologist does not have any further details at this time. Sudep has not been ruled out. Good faith attempts are underway for further details.
 
Manufacturer Narrative

Event Description
Good faith attempts have been made and no further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2664669
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dennis100
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« Reply #302 on: October 12, 2018, 04:53:53 PM »

Model Number 103
Device Problem Insufficient Information
Event Date 02/27/2012
Event Type  Death   
Manufacturer Narrative
Death, date of event; corrected data: additional information was received regarding the date the patient passed away.
 
Manufacturer Narrative
Outcomes attributed to adverse event; corrected data: this information was inadvertently left off of supplemental 03 mfr. Report. Type of reportable event; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report.
 
Event Description
Additional information was received on (b)(4) 2012, when a sudep evaluation was performed over the information received thus far which was determined to be possible sudep. The patient's neurologist reported that she passed away on (b)(6) 2012 and the last time he saw her was on (b)(6) 2012. They had no information on the cause of her death. Additional information was requested from the patient's primary care physician regarding the patient's death but no further information has been received to date.
 
Manufacturer Narrative
 
Event Description
On (b)(6), 2012 a vns treating neurologist reported that the vns patient has passed away in (b)(6) 2012. No cause of death was provided. The patient had switched neurologists and the neurologist that the patient was seeing at the time of her death is unknown. Attempts for further information are underway.
 
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2012 and the patient's cause of death was unspecified and cardiogenic shock. A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of possible sudep. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
Additional information was received on (b)(6) 2012, when the office of vital records in the state passed away in reported that a copy of the patient's death certificate will not be provided as the company of the patient's medical device is not eligible to obtain a death certificate.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2668852
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dennis100
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« Reply #303 on: October 14, 2018, 12:55:01 PM »

Model Number 103
Event Date 07/27/2012
Event Type  Injury   
Event Description
Additional information was received from an epilepsy specialist nurse that she was not sure of the conclusion from the cardiologist but initially their treating physician did not feel that her symptoms were cardiac. An initial ecg and bloods were unremarkable. It was planned for the patient to have an echocardiogram and 24 hour blood pressure. Unknown if this has occurred. As additional information is attained it will be sent to the manufacturer.
 
Event Description
It was reported that a patient in (b)(6) who was implanted two months ago is presenting with an abnormal electrocardiogram. The patient was going to be followed by a cardiologist. The patient also had complaints of chest pain and she has a history of cardiac problems. Their chest pain was determined to not be vns related. Further investigation is underway in regards to their abnormal electrocardiogram.
 
Manufacturer Narrative
Suspect medical device corrected data:. Labeling was attained and not added to the initial mdr report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2713440
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dennis100
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« Reply #304 on: October 14, 2018, 12:55:54 PM »

Model Number 102
Event Date 06/08/2012
Event Type  Injury   
Manufacturer Narrative
Device manufacture data, corrected data: an incomplete manufacture date was inadvertently provided on the initial mdr report. The complete manufacture date is provided.
 
Event Description
Additional manufacturer follow-up identified the patient's treating neurologist; however, the neurologist has not seen the patent since (b)(6) 2011 and was unaware of any cardiac events and has no information regarding the arrhythmia or syncope events. Additional manufacturer follow-up with the pacemaker surgeon revealed he had no information and declined to discuss the events further. Vns diagnostics were within normal limits during the pacemaker surgery on (b)(6) 2012.
 
Event Description
It was reported by a surgeon that a vns patient would be implanted with a pacemaker due to the experienced events of syncope and 3 second delays in heart rhythm. The surgeon had no additional information regarding the patient's medical history. Additional information was received through the area representative who indicated he was present at the time of the pacemaker surgery. The representative indicated that he was able to successfully interrogate the patient's vns prior to surgery. At the moment good faith attempts to obtain further information regarding the reported 3 second delay and syncope have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2637436
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dennis100
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« Reply #305 on: October 14, 2018, 12:57:06 PM »

Model Number 102
Event Date 06/27/2012
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received for a vns patient reporting that the patient has a history of seizure-like spells which appear to be associated with episodes of syncope, tonic-clonic activities. The patient has episodes of syncope after standing for two minutes, and it was unclear if it was related to orthostatic hypotension or cardiac dysrhythmias. He was referred to be evaluated by cardiology. The physician noted the patient would benefit from coumadin for secondary stroke prevention due to the atrial fibrillation. The physician turned off the vns device on this visit, (b)(6) 2012, as the patient requested. Additional notes were received indicating the patient has two types of spells which he passes out, and the vns indications are not clear. This was the first appointment with this physician. The patient however has not had any recent seizures, but feels the vns may need to be explanted. Follow up with the physician's office confirmed that they do not know the relationship of the arrhythmia and syncope events to vns as the patient was first evaluated on (b)(6) 2012. They disabled the device on (b)(4) 2012 because they do not know if the patient's seizures are epilepsy related to related to alcohol. Therefore, they turned it off to see if the seizure frequency increases without vns. There were no notes to indicate that diagnostics were taken prior to the device being disabled. There was no strong indication why the patient feels the generator should be explanted. However, per the notes, the physician indicated that he will not suggest to have it explanted until the etiology of the patient's seizures are clear. It is unknown to date if the device disablement will be permanent or temporary. The office was unable to provide additional information. Although the patient is requesting explant, the physician suggested turning the device off first and monitoring his symptoms. Although surgery may occur in the future, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2720145
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dennis100
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« Reply #306 on: October 14, 2018, 12:57:48 PM »

Model Number 102
Event Date 04/10/2012
Event Type  Injury   
Event Description
Attempts to the treating physician for additional information have remained unsuccessful.
 
Event Description
Clinic notes received on (b)(6) 2012 and dated (b)(6) 2012 reported that the patient is implanted with a pacemaker. The patient's specific heart condition, as well as its relationship to vns is unknown at this time. Attempts for additional information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2715954
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dennis100
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« Reply #307 on: October 18, 2018, 02:40:09 AM »

Event Date 01/01/2010
Event Type  Injury   
Event Description
It was initially reported the company rep that the pt had a recent ekg that contained an abnormality, unk if related to vns or if the pt has a history of cardiac events. Good faith attempts to gain more info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1953497
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dennis100
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« Reply #308 on: October 19, 2018, 12:00:46 PM »

Model Number 102
Event Date 06/16/2014
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized for five days on (b)(6) 2014 for rapid ventricular rate, atrial fibrillation and flutter. On (b)(6) 2014 the patient was admitted to the hospital for chest pain. The patient underwent transesophageal echocardiogram on (b)(6) 2014 and no clots were observed. The patient received cardioversion on (b)(6) 2014 and the heart rate returned to normal. The patient indicated that his inr was high and he had undergone pulmonary and gi testing. The patient's inr dropped below 2 and the patient underwent cardiac catheterization. The patient was released from the hospital on (b)(6) 2014. The relationship of the cardiac events to vns are unknown. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
The patient's cardiologist reported that the patient has a history of mitral valve regurgitation with replacement and cardiomyopathy. There were no medication changes or other factors that could have caused or contributed to the arrhythmia. The patient also has a history of first degree av block and sinus bradycardia. The patient the patient experienced atrial flutter with a heart rate of 122 bpm. The patient experienced dyspnea and palpitations during the atrial flutter. The patient underwent tfe with cardioversion. The atrial flutter did not recur. The patient's neurologist indicated that there is no relationship between the atrial flutter and vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4166277
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