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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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« 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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« 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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dennis100
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« Reply #309 on: October 27, 2018, 01:19:43 AM »

Model Number 102
Event Date 03/21/2011
Event Type  Injury   
Event Description
On (b)(6) 2011, the manufacturer was called by a pacemaker company's representative requesting pacemaker precautions for a vns patient. The representative did not know what type of arrhythmia the patient is experiencing. The representative was informed of the pacemaker and electrocautery precautions for vns patients. Good faith attempts have been made to the patient's neurologist and cardiologist; however, no further information has been received. If additional information is gained, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2044885
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« Reply #310 on: October 27, 2018, 05:56:56 AM »

Model Number 102
Event Date 10/01/2014
Event Type  Death   
Event Description
It was reported that a vns patient had passed away. The patient had a heart attack in 2014, no exact date given, and passed away. The patient reportedly had chronic heart problems. A review of the manufacturer's in house programming history identified the patient's last known settings in (b)(6) 2014. All diagnostic results available were within expected limits. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5987277
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dennis100
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« Reply #311 on: October 27, 2018, 06:00:20 AM »

Model Number 103
Event Date 03/07/2015
Event Type  Death   
Event Description
It was reported that the patient had passed away recently and had experienced increased seizures prior to death. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. The patient was reported to have been buried by the funeral home. Attempts made for additional relevant information regarding patient's death were unsuccessful. A copy of the death certificate is being requested. Attempts were made for the patient's vns products but they have not been received to date.
 
Event Description
Additional information was received that the patient¿s cause of death remains unknown as the medical examiner¿s office is performing toxicology tests to see if it might be drug overdose and have not determined the cause of death. An autopsy was performed on (b)(6) 2015 but the results will not be released until all tests are completed. Additional attempts made for the autopsy report were unsuccessful to date. The explanted generator and lead were returned on 4/7/2015. A large portion of the lead assembly (body) including the electrodes was not returned for analysis. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure and no obvious anomalies were noted. Analysis of the returned generator is underway but has not been completed.
 
Event Description
Patient's death certificate was received stating that the cause of death was atherosclerotic cardiovascular disease. Patient had this disease for years along with medically significant obesity. Patient's manner of death was natural and patient died at home.
 
Manufacturer Narrative

Event Description
Analysis of the returned generator was completed. The pulse generator diagnostics were as expected for the programmed parameters. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4656704
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dennis100
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« Reply #312 on: October 27, 2018, 06:01:06 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/14/2017
Event Type  Death   
Event Description
The patient was reported to have passed away in hospice due to congestive heart failure. Additional relevant information has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6563117
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dennis100
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« Reply #313 on: October 28, 2018, 12:51:27 AM »

Model Number 104
Event Date 09/25/2012
Event Type  Death   
Event Description
The physician reported that he did not know the cause of death, but did not think that the death was sudep or related to vns therapy. The death certificate was received and listed the immediate cause of death as acute cardiopulmonary collapse (approximate interval between onset and death: immediate) due to coagulopathy. Other significant conditions contributing to death, but not resulting in the underlying cause given was listed as infection, epilepsy, chronic encephalopathy and ataxia. The physician reported that he does not feel the patient's infection was related to vns therapy. The physician declined to provide any additional information.
 
Manufacturer Narrative
 
Event Description
A funeral home called to return a explanted lead and generator from a vns patient who had passed away. No further details were provided surrounding the patient's cause of death and relationship to their vns. It was reported the patient had their products explanted in the last month but exact date of death not provided. Exact explant date not known. Analysis was performed on their explanted lead. The generator analysis is pending completion. An analysis was performed on the returned lead portions. Note that portions of the marked and unmarked connector boots, including a portion of the serial number tag was not returned therefore; it was not possible to verify the serial number during this analysis. The lead assembly (body) including the electrodes was also not returned; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device. Note that since portions of the marked and unmarked connector boots, the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
The generator pa was completed on (b)(4) 2013. Analysis of the generator showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows a non-ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator. The generator decoder found that a high impedance condition existed prior to explant. This is reported in mfr report # 1644487-2013-02260.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3180767
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« Reply #314 on: October 28, 2018, 12:52:14 AM »

Model Number 102
Event Date 07/16/2013
Event Type  Death   
Event Description
On (b)(4) 2013, it was reported that the patient passed away at home few days earlier ((b)(6) 2013) due to myocardial infarction. Attempts have been made for additional information, but they have been unsuccessful. No additional information has been provided.
 
Event Description
The national death index from the cdc website listed the patient's causes of death as drowning and submersion while in swimming pool, atherosclerotic cardiovascular disease, drowning and nonfatal submersion, and other ill-defined heart diseases.
 
Manufacturer Narrative
 
Event Description
Further follow-up revealed that the physician indicated that the device had been programmed off and therefore the death was not related to vns therapy. The physician indicated that the patient had parkinson's disease and suffered a heart attack and that the death was not related to vns therapy. The device disablement was previously reported in mfr. Report # 1644487-2010-01378.
 
Event Description
The explanted product and a product return form were received by the manufacturer. The cause of death was listed as drowning. Additional circumstances surrounding the death were listed as atherosclerotic cardiovascular disease. Analysis of the explanted lead and generator did not reveal any anomalies or performance issues however, the entire lead was not returned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3298712
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« Reply #315 on: October 28, 2018, 12:52:59 AM »

Model Number 102
Event Date 06/04/2012
Event Type  Death   
Event Description
On (b)(6) 2012, a vns patient's son reported that the vns patient had recently passed away. The son reported that the death was not related to vns. An online obituary search showed that the patient's date of death was (b)(6) 2012. On (b)(6) 2012, follow up with the funeral home and physician's office was performed. Follow up with the associated funeral home revealed that the device was explanted prior to burial and discarded. It was also stated that the cause of death was cardio-respiratory failure. The physician's office stated that the patient had not been seen for some time. A battery life calculation was performed on (b)(6) 2012 with 9. 18 years to eri=yes. Attempts for additional information have been unsuccessful.
 
Event Description
This death event has been evaluated and with the available information the death has been determined to be possible sudep. Even though the funeral home reported the cause of death was cardiorespiratory failure, this is very vague and ultimately all deaths occur as a result of cardiorespiratory failure in some manner. The circumstances of the death, the general health of the patient, location of the death (inpatient or at home), and if seizures were involved with the death are all still unknown. As such, sudep cannot be ruled out as a possible cause of death.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2012, the patient's death certificate was received. The certificate indicated that the patient passed in a natural manner. The underlying cause was cardiorespiratory failure (few days), septic shock with multi-system organ failure, and chronic liver disease with (b)(6). Follow-up with the patient's physician showed that no information was available regarding the patient. A sudep evaluation was performed with the new information. This death event has been reviewed and with the available information has been determined not to be sudep. Per the death certificate, the cause of death was cardiorespiratory failure, septic shock with multi-organ failure, and chronic liver disease with (b)(6). Although the location of the death is not listed on the death certificate, it is likely the patient died in a hospital setting due to the reported event of septic shock and multi-organ failure. The patient was likely in a poor state of health at the time of death, and the death was likely witnessed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2672168
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« Reply #316 on: October 28, 2018, 12:53:40 AM »

Model Number 103
Event Date 02/17/2010
Event Type  Death   
Event Description
On (b)(6), 2012, a physician reported that this vns patient had passed away. The physician believed that the patient died of seizures but did not have any additional information. An obituary determined the date of death to be (b)(6), 2010. On (b)(6), 2012, follow up with the mortuary associated with the patient's death revealed that because the device contained a battery, it would have been removed and disposed of properly in 2010; therefore, return of the device for product analysis is not possible. Additional follow up with the physician was conducted, and no information was available; however, another physician's name was provided as a potential source of information. Follow up with the suggested physician on (b)(6), 2012 revealed that the patient's cause of death was a cardiac arrhythmia due to an epileptic seizure. The relationship of the patient's death to vns was unknown, and no additional information was provided.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2617074
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« Reply #317 on: October 28, 2018, 12:54:28 AM »

Model Number 102
Event Date 12/02/2014
Event Type  Death   
Manufacturer Narrative

Event Description
Attempts for the vns products were made and it was reported that the funeral home will not return medical devices as the patient¿s family might want it later on in the future. It is unknown if the patient¿s device was explanted or not. Death certificate indicates that the patient's cause of death is due acute myocardial infarction, secondarily due to coronary heart disease, diabetes and chronic obstructive pulmonary disease. Patient was cremated and an autopsy was not performed. Tobacco use did contribute to death. An internal sudep evaluation was performed by the manufacturer which determined the death to be unlikely sudep.
 
Event Description
It was reported that the vns patient passed away on (b)(6) 2014. The cause of death and its relationship to vns are unknown. It was noted that the patient had numerous medical issues. The patient was last seen by the neurologist over a year ago and diagnostic results showed normal device function at the time. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4443657
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« Reply #318 on: October 28, 2018, 12:55:13 AM »

Model Number 102
Event Date 12/09/2010
Event Type  Death   
Event Description
A copy the death certificate was received where it states that the immediate cause of death was probable cardiac dysrhythmia due to angiomyolipomas of the heart in association with tuberous sclerosis. An autopsy was performed.
 
Event Description
Additional information was received indicating that the vns patient¿s device was not explanted after passing away. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
It was reported that the vns patient passed away from status epilepticus. The patient¿s obituary stated that the patient died in the hospital on 12/09/2010 and faced lifelong medical challenges of tuberous sclerosis. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Cyberonics, inc. Submits this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation, based on information that cyberonics has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3715018
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« Reply #319 on: October 28, 2018, 12:55:53 AM »

Model Number 102
Event Date 08/22/2013
Event Type  Death   
Manufacturer Narrative
 
Event Description
Additional information was received from the vns treating physician that the patient's death was unlikely related to vns therapy. The patient's death was sudden and was thought to be cardiac. The patient slumped over in front of the mother in the daytime, and she did not think it was a seizure. The patient was taken to the er and was unable to be resuscitated. The patient had a family history of sudden death in a relative. The patient had reduced seizures with vns and was receiving therapy at time of death. There was no prior history of cardiac or respiratory problems. Analysis of the generator and lead was completed. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
It was reported that the vns patient passed away and the explanted device was available for returned. The generator and lead were received for analysis. Analysis is underway, but has not been completed to date. The cause of death is unknown. The relationship of vns to the cause of death are unknown. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3913891
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« Reply #320 on: October 28, 2018, 12:56:34 AM »

Model Number 101
Event Date 05/20/2008
Event Type  Death   
Manufacturer Narrative

Event Description
The funeral home indicated that the cause of death was cardiopulmonary disease and the manner of death was natural. There was no other information available. The physician indicated that the patient was last seen on (b)(6) 2007 and he does not have an opinion on the death.
 
Event Description
It was reported that the vns patient passed away. The cause of death and relationship of the death to vns is unknown. No additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4410520
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« Reply #321 on: October 28, 2018, 12:57:12 AM »

Model Number 102
Event Date 04/21/2007
Event Type  Death   
Manufacturer Narrative
 
Event Description
It was reported that the vns patient passed away. The cause of death is unknown. The relationship of the death to vns is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
A copy of the patient's death certificate was received where the cause of death was documented as acute fatal cardiac arrhythmia due to or a consequence of the patient¿s seizure disorder. A review of the programming history revealed that the device was performing as intended.
 
Manufacturer Narrative
Review of programming/device diagnostic history performed. Date of event, corrected data: the initial report indicated the date of death was (b)(6) 2007 however it was actually (b)(6) 2007. The information has been corrected in this report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3939064
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dennis100
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« Reply #322 on: October 28, 2018, 12:58:02 AM »

Model Number 103
Event Date 05/04/2013
Event Type  Death   
Event Description
It was initially reported that the patient passed away due to unknown causes and the relationship of the death to vns was not provided. The funeral home reported that the patient was buried with the generator and lead, so it will not be available for return to the manufacturer for evaluation. The cause of death was later determined to be cardiac arrhythmias due to insecure medications below therapeutic levels. Following-up with the physician did not provide any additional information about the patient¿s death.
 
Manufacturer Narrative

Event Description
It was reported that the physician did not think there was anything wrong with the patient's device.
 
Event Description
Additional information was returned from the physician that the patient¿s death was not believed to be related to vns. It was unknown if the patient had a pre-vns history of cardiac arrhythmias.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3156826
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dennis100
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« Reply #323 on: October 29, 2018, 11:25:33 AM »

Event Type  Death   
Manufacturer Narrative
 
Event Description
It was reported in an article that a patient died due to a heart disease. No other information regarding the event is available in the article. Attempts for further information from the authors of the article were unsuccessful. Therefore the relationship between the patient's death and vns therapy cannot be determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1631948
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dennis100
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« Reply #324 on: October 30, 2018, 01:07:00 AM »

Model Number 103
Event Date 01/31/2012
Event Type  Death   
Event Description
On (b)(6) 2012, correspondence with the user facility's autopsy director revealed that the patient was in status epilepticus, and the generator was implanted as an intervention. It was believed that the death was not related to vns. The autopsy report was provided to the manufacturer. The autopsy report indicated that the patient was healthy until (b)(6) 2012, when she developed high fevers, without other symptoms. On (b)(6) 2012, antibiotics were started for a throat infection but the fevers persisted. On (b)(6) 2012, the patient was lethargic, and during the night, she was found unresponsive with muscle stiffness and her eyes open. The patient was intubated at an emergency department. The patient was transferred to another facility and admitted directly to intensive care. The cerebrospinal fluid had 4 neutrophils/ml and normal numbers of lymphocytes; the glucose was elevated. An mri showed localized edema of the hippocampi and fornical column, probably postictal edema. An extensive infectious disease workup on the blood and csf was negative, looking for bacteria, including bartonella, viral encephalitis viruses, adenovirus, and herpes simplex virus. The acylcarnitine profile, blood amino acid screen and urine organic acids were negative for metabolic disease, and a paraneoplastic work-up was negative. Pulse steroids were given for a possible autoimmune encephalitis. From admission, the patient had persistent seizure activity in spite of multiple antiepileptics. A pentobarbital infusion did not stop seizure activity despite burst suppression; when pentobarbital was stopped because of possible propylene glycol toxicity, a versed infusion was given, also without effect. A series of therapeutic apheresis procedures was started. On (b)(6) 2012, inhaled sevoflurane was started, also without effect on the seizures; epinephrine was required for hypotension and lasix for volume overload. The latter was subsequently replaced by hemofiltration. The vns device was placed on (b)(6) 2012. Despite all measure, status epilepticus continued. An echocardiogram on (b)(6) 2012, showed mildly decreased left ventricular function, and a follow-up on (b)(6) 2012, showed severe right and left ventricular systolic dysfunction and pericardial effusion, which did not respond to treatment with pressors. Care was redirected at the parents' request and death occurred on (b)(6) 2012. Per the autopsy report, significant autopsy findings included global ischemic encephalopathy with astrogliosis involving multiple areas of the brain. These findings are consistent with the effects of status epilepticus; inflammation or other findings indicating an etiology of the patient's initial high fevers and status epilepticus were not identified in the brain or in the other organs. Features of cardiac failure and dilation were evident, but aside from minor preterminal ischemia, the myocardium was histologically unremarkable. Based upon the autopsy report, the principle diagnosis of the death was global ischemic encephalopathy and gliosis with features of cardiac failure. Cardiac failure occurred; however, the cause or causes of the fevers, seizures, and terminal cardiac failure were not identified during the clinical course or at autopsy; in particular, there was no anatomic indication of an infectious disease, an inflammatory process, or an intrinsic abnormality of the brain. Possible etiologies include a late-presenting mitochondrial disorder, another metabolic or hereditary disease, or an unknown acquired disorder of the central nervous system. The autopsy also did not determine how or whether the neurologic condition and the cardiac failure were related to each other, and an anatomic cause of the cardiac failure was not identified.
 
Event Description
On (b)(6) 2012, a hospital reported that a vns patient had passed away. The patient's generator and lead were explanted by the funeral home. The date of death was provided as (b)(6) 2012; however, no additional information was available. The patient's explanted generator, with lead still attached, was returned on (b)(6) 2012 and is currently undergoing product analysis. Programming history from the date of surgery shows that the device not programmed on. Two system diagnostics from the date of implant indicated normal results. Attempts for additional information have been unsuccessful.
 
Manufacturer Narrative
Review of programming history.
 
Event Description
Generator product analysis was approved on (b)(6) 2012. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. The generator was returned programmed on to deliver therapy. The lead assembly was returned. Scanning electron microscopy of the positive coil show that pitting or electro etching conditions have occurred at the cut end. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant (generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load - cut leads). Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. A fax from the surgeon on (b)(6) 2012, indicated that the surgeon was unaware, and no additional information was provided. Attempts to contact the pathology, neurology, neurosurgery, and medical records departments at the facility where the patient was implanted have been unsuccessful, but are still underway. Contact with the initial reporter corrected that the device was not received from the funeral home. Attempts to obtain information from the funeral home are in progress. A manufacturer's consultant present at the patient's implant surgery noted that the that the patient was a four-year-old admitted for cold symptoms two weeks ago and began having seizures have were uncontrolled with medications. The patient developed a phb (phenobarbital) toxicity. The patient was an inpatient; therefore, the neurologist was unknown. Diagnostics from the implant surgery were also provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2769865
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dennis100
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« Reply #325 on: October 30, 2018, 01:08:23 AM »

Model Number 103
Device Problem Insufficient Information
Event Date 06/24/2011
Event Type  Death   
Event Description
It was initially reported that the patient passed away in her sleep. The cause of death and the relationship to (b)(6) is unknown. Good faith attempts for more information and product return have been unsuccessful to date.
 
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) 2011 and the patient's cause of death was unspecified cardiac arrhythmia, accompanied by other and unspecified convulsions. A sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death met criteria for classification of probable sudep. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
A response was received from the physician that indicated that there was an autopsy that was performed by it will not be provided. No further information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2188653
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dennis100
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« Reply #326 on: October 31, 2018, 02:17:23 AM »

Model
« Last Edit: October 31, 2018, 03:40:00 AM by dennis100 » Logged
dennis100
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« Reply #327 on: October 31, 2018, 02:18:06 AM »

Model Number 102
Event Date 01/01/2012
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2012, revealed that the patient has a history of cardiac arrhythmia. Additionally, it was noted that the patient was experiencing left chest pain (relationship not reported). The physician has recommended that the patient follow-up with the cardiologist for an ekg prior to undergoing generator replacement, for which is being reported in manufacturer report #: 1644487-2012-03152. Attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
 
Manufacturer Narrative
Relevant tests/laboratory data, including dates: the initial report inadvertently reported the system diagnostic results incorrectly.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2852443
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dennis100
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« Reply #328 on: November 02, 2018, 08:48:39 AM »

Model Number 102
Event Date 09/13/2014
Event Type  Death   
Event Description
It was reported that the vns patient passed away and was undergoing an autopsy. It was later reported that the patient passed away in her sleep and was found the next morning. The cause of death is pending the final death certificate completion. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient¿s device was buried with the patient; therefore, no analysis can be performed. The death certificate listed the cause of death as sudden cardiac arrest subsequent to dilated cardiomyopathy. Based on the available information about the patient¿s death, an internal classification has determined that the death was unlikely sudep.
 
Manufacturer Narrative
Cyberonics, inc. Submits this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation, based on information that cyberonics has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4193323
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dennis100
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« Reply #329 on: November 04, 2018, 02:04:26 AM »

Model Number 102R
Event Date 01/01/2008
Event Type  Injury   
Event Description
It was initially reported in clinic notes that the patient has congestive heart failure and cerebral hematoma. It is unknown if these events were related to vns.
 
Manufacturer Narrative

Event Description
Good faith attempts for more information were unsuccessful. Follow-up with the physician's office indicated that they did not feel comfortable commenting regarding the patient's events and did not provide any further information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2394303
« Last Edit: November 05, 2018, 11:40:34 AM by dennis100 » Logged
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