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dennis100
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« Reply #30 on: June 13, 2018, 01:12:35 AM »

Model Number 106
Device Problem No Information
Event Date 12/01/2015
Event Type Death
Manufacturer Narrative
Suspect device udi: (b)(4).

Event Description
It was reported that the patient passed away on (b)(6) 2015. The nurse reported that the patient has a history of dementia and depression. The coroner reported that the patient drowned in the river by his home. The coroner's office indicated he may have fallen by his home as evidenced by blood found on the porch of his home and he was not seen alive thereafter, but no foul play was suspected. The preliminary autopsy findings indicate the patient suffered from two prior heart attacks with 50% blockages in several coronary arteries but no thrombi. The autopsy authorization form was received which reported that the patient vns therapy has reduced the length of the patient's seizures, and he had not had a known seizure since (b)(6). The patient was found in the river over a mile from his home. He was caught on a pier, and he had been reported missing the previous evening. He lives in an apartment in from of his brother's home. He usually brings the mail at a particular time of day. When he didn't, his brother went to look for him, eventually calling police. The found the mail strewn on the front steps of the home with a small blood spot on the first step. The patient was found in the river by police. The cause of death is unclear. The explanted products were received by the manufacturer for analysis. However, analysis has not been completed to death.

Event Description
Analysis was completed on the explanted devices. The pulse generator performed according to functional specifications throughout all testing in the analysis lab. The battery showed an ifi=no condition. There were no performance or any other type of adverse condition 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. No other anomalies were identified in the returned lead portion.

Event Description
The coroner reported that it is assumed that the patient became confused post-ictally and walked in the opposite direction of his brother's home in the direction of the lake. They assume that he then inadvertently walked into the water and was taken by the water.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5312869
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dennis100
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« Reply #31 on: June 13, 2018, 01:17:09 AM »

Model Number 102R
Event Date 11/14/2012
Event Type Death
Event Description
Multiple attempts for the patient's explanted product have been made and at this time no further information is known if it will be returned for analysis. Multiple attempts have been made for further information in regards to the patient's death but thus far no further information has been attained. The patient lived in a very rural area and was not seen by a regular physician.

Event Description
It was reported to our local partner in ecuador that a vns patient died on (b)(6) 2012, from a heart attack. It has not yet been confirmed that the event was not related to vns therapy. Their vns system has been explanted and is pending being returned for analysis. The patient was in (b)(6) and our local partner is in (b)(4). It could take several weeks to get the product returned for analysis. It was reported per the patient's brother that they had no history of any drug or alcohol abuse, no history of cardiac or respiratory problems. The patient was compliant with their medications. The patient did have a reduction of their seizures with the vns. The device was programmed on at the time of death. The patient's death was reported to be from a heart attack. Their death was not witnessed. No report of any trauma. The patient died during their sleep. No other information has been provided in relation to their death from a medical professional. Based on that sudep cannot be ruled out at this time. The patient does have nocturnal seizures, simple partial complex partial.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2886214
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dennis100
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« Reply #32 on: June 15, 2018, 02:00:20 AM »

Model Number 103
Event Date 05/05/2014
Event Type  Death   
Event Description
It was reported that the vns patient passed away in her sleep on (b)(6) 2014. The physician suspected sudep. The patient¿s device was not explanted prior to cremation.
 
Manufacturer Narrative

Event Description
A copy of the autopsy report was received where the cause of death was listed as atherosclerotic cardiovascular disease (hardening of the arteries of the heart) and a seizure disorder. At autopsy, there were focal areas of myocardial fibrosis indicating that the deceased had suffered multiple myocardial infarctions (heart attacks) in the remote past. The deceased also suffered from a seizure disorder which also contributed to her death. The manner of death was listed as natural. An internal sduep evaluation was performed and it was determined that the death was unlikely sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3840356
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dennis100
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« Reply #33 on: June 28, 2018, 12:46:42 AM »

Model Number 102R
Event Date 01/17/2012
Event Type  Injury   
Event Description
It was reported on (b)(6) 2012 that a patient implanted with vns in 2005 was going to be implanted with a defibrillator on (b)(6) 2012 due to arrhythmia. The patient presented in the er with arrhythmia and it was determined he needed a defibrillator implant. Good faith attempts to obtain additional information were unsuccessful as the physician has moved and his current residence is unknown.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(4) 2012, when it was reported that the patient had a heart attack in (b)(6) and defibrillator paddles were used. The patient now sees a new physician however good faith attempts to obtain additional information from the physician have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2438667
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dennis100
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« Reply #34 on: June 28, 2018, 12:47:48 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 12/21/2011
Event Type  Death   
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient's cause of death was acute myocardial infarction, (unspecified), essential (primary) hypertension, gastrointestinal hemorrhage (unspecified), and other and unspecified convulsions. There is no allegation or other information indicating that the death is related to vns.
 
Manufacturer Narrative

Event Description
The manufacturer reviewed the national death index information and the cause of death for the patient was reported to be acute myocardial infarction (unspecified).
 
Event Description
It was reported to a manufacturer representative in passing at a health system that the patient passed away. No further details were known by the hospital staff. The last known treating vns physician did not report the death. The last known treating vns physician reported to the manufacturer in (b)(6) 2014 that the patient was lost to follow-up. Therefore, they were not aware of the death. Good faith attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4340246
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dennis100
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« Reply #35 on: June 28, 2018, 12:48:33 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 #36 on: October 12, 2018, 04:55:51 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 #37 on: October 16, 2018, 03:23:06 PM »

Model Number 102
Event Date 07/09/2009
Event Type  Death   
Event Description
All attempts to the reporter for additional information have been unsuccessful to date. Follow up with the vital records office revealed the cause of death was cardiopulmonary arrest caused by a myocardial infarction.
 
Event Description
It was reported that the patient passed away. The date of death was (b)(6) 2009. No information regarding the death or the relationship of the death to the vns was provided. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2687856
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dennis100
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« Reply #38 on: October 27, 2018, 06:03:36 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 #39 on: October 27, 2018, 06:04:44 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/09/2017
Event Type  Death   
Event Description
It was reported by the physician's office that the patient had passed away. The physician's office did not have any further details regarding the patient's death. Follow up with the care facility's office manager revealed that the patient died of a heart attack. A medical professional's assessment of the relation of the patient's death to the vns is unknown to date. The disposition of the patient's device is unknown to date. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Follow up with the funeral home revealed that the vns would have been left in the patient as they were not cremated.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7042985
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dennis100
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« Reply #40 on: October 27, 2018, 06:06:35 AM »

Model Number 102
Device Problem Insufficient Information
Event Date 08/07/2011
Event Type  Death   
Manufacturer Narrative

Manufacturer Narrative
Name and address, corrected data: additional information was received which found that the incorrect initial reported was listed in the initial mdr inadvertently. Occupation, corrected data: incorrect occupation listed on the initial mdr based on additional information received.
 
Event Description
On (b)(6) 2012, a manufacturer's sales representative reported that a vns patient passed away. Prior to this notice, the patient had been referred to the surgeon by the patient's treating vns neurologist to discuss generator replacement due to end of service (eos). However, the patient reportedly never had the consult which prompted the sales representative to follow up with the surgeon's office and led to the discovery that the patient passed away. No other information was provided at this time.
 
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 acute myocardial infarction. There is no allegation or other information indicating that the death is related to vns.
 
Event Description
It was reported that the patient passed away on (b)(6) 2011 from an unknown cause. The patient's physician was contacted to try and get additional information; however, the physician had no knowledge of the patient's death and did not know any other physicians who would. No further information has been received at this time. No autopsy or death certificate has been obtained. It is unknown if the patient had their product explanted and therefore not attained for analysis. Based on the available information that the patient had epilepsy and passed away, it was noted that sudep could not be ruled out as a possible cause of death. However, it is unknown what the true cause is as no other information is available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2835941
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dennis100
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« Reply #41 on: October 27, 2018, 06:07:40 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/08/2014
Event Type  Death   
Event Description
It was reported by a physician's office that a vns patient was deceased. She was reported to have gone to the emergency room for a headache, was discharged and later expired. The cause of death is unknown to-date. Device system diagnostics on (b)(6) 2014 were within normal limits. Additional information has not been received to-date.
 
Event Description
Follow-up to the funeral home where services were performed revealed the cause of death was cardiac arrhythmia. It was reported there was no record that the device had been explanted prior to services and was likely buried with the patient. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Event description, corrected data: the event description inadvertently provided the event as headache. The reported event was heart attack.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5333050
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dennis100
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« Reply #42 on: October 27, 2018, 06:08:25 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Death   
Event Description
Additional information was received from the physician's office that indicated that the patient's death was not related to vns. No additional relevant information has been received to date.
 
Manufacturer Narrative
 
Event Description
It was reported by the physician's office the patient had passed away due to a heart attack. It was unknown if the physician believes the heart attack was related to vns or not. Additionally, the date of the patient's death was not provided. A battery life calculation was performed which showed the patient had approximately 0 years remaining at some point prior to 2015. No anomalies were noted and the diagnostics were dcdc = 0, indicating the device was working as intended. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6315940
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dennis100
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« Reply #43 on: October 28, 2018, 12:59:51 AM »

Model Number 103
Event Date 01/10/2014
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that a patient died on (b)(6) 2014. The primary cause was myocardial infarction, and the secondary cause was cerebral palsy. It is unknown if the device was explanted prior to burial/cremation. Therefore, the device was not available for return. The patient's last known physician did not have any record of prior cardiac issues for this patient. No further information was available to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5240607
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dennis100
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« Reply #44 on: October 28, 2018, 01:00:30 AM »

Model Number 102
Event Date 12/18/2012
Event Type  Death   
Event Description
An emergency room (er ) log for the patient was received. The patient presented to the er pulseless via ems who had administered cpr. The symptoms occurred just prior to arrival. The patient was intubated and given meds and cpr in the er. The patient was then pronounced dead as resuscitation attempts were unsuccessful.
 
Manufacturer Narrative
 
Event Description
An online obituary was found indicating that the vns patient passed away on (b)(6) 2012. Follow-up with the funeral home revealed that the patient died from a myocardial infarction. The patient¿s device was not explant prior to burial; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3926534
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dennis100
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« Reply #45 on: October 28, 2018, 01:01:07 AM »

Model Number 102R
Event Date 08/11/2012
Event Type  Death   
Event Description
An online obituary was found indicating that the vns patient passed away. It was noted that the patient passed away in the hospital. Follow-up with the funeral home found the cause of death to be a heart attack. It was reported that there was no indication that the device was explanted and that the patient was buried. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
On (b)(6) 2014 the physician reported that it was unknown if the patient had a history of cardiac issues. He stated that the relationship of the patient¿s death to vns is not related.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4203237
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dennis100
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« Reply #46 on: October 28, 2018, 01:02:01 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 #47 on: October 28, 2018, 01:02:43 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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dennis100
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« Reply #48 on: October 28, 2018, 01:03:20 AM »

Model Number 101
Event Date 12/09/2008
Event Type  Death   
Manufacturer Narrative
 
Event Description
An online obituary identified that the patient passed away from natural causes at her home. Further follow-up revealed that the patient was found face down on the floor of her apartment. The patient had passed away and their were no signs of foul play. The death certificate noted that the patient passed away from natural causes and the immediate cause of death was listed as acute myocardial infarction with a significant condition contributing to the death as being obesity. It was reported that no autopsy was performed. It was reported that it was not known the patient was implanted with vns and the patient was cremated without device explant.
 
Event Description
It was reported that the patient passed away. No cause of death was provided. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3287768
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dennis100
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« Reply #49 on: October 28, 2018, 01:04:05 AM »

Model Number 103
Event Date 04/09/2016
Event Type  Death   
Event Description
It was reported that the vns patient passed away due to a heart attack. The online obituary indicated that the patient passed away at the hospital. The physician indicated that the death was not known, but that the patient was scheduled to undergo generator replacement due to end of service (pulse disabled). The patient was not receiving vns therapy at the time of death as a result of expected battery end of life. The funeral home indicated that the patient was buried with the device; therefore, no product analysis can be performed. The hospital records indicated that the patient collapsed at the group home and cardiopulmonary resuscitation was performed for 45 minutes until the patient regained spontaneous pulses. The patient was then transferred to the hospital where she again arrested. Cpr was performed again for 15-20 minutes and the patient was transferred to the icu. The patient's family informed that the patient had a do not resuscitate order and at this time they wished to withdraw care due to the poor prognosis. Comfort measures were taken and the patient passed away.
 
Manufacturer Narrative

Event Description
Based on the initial report there is no indication that the patient's death due to heart attack is related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5653685
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« Reply #50 on: October 28, 2018, 01:04:59 AM »

Model Number 106
Event Date 05/11/2016
Event Type  Death   
Manufacturer Narrative
Outcomes attributed to adverse event, corrected data: some of the additional outcomes attributed to the event were inadvertently not marked on the initial mdr.
 
Event Description
It was reported to a company representative by a physician's office that a vns patient was deceased. It was indicated to have happened a few weeks prior by the reporting nurse. Follow-up with the physician revealed that the patient passed away due to a heart attack. The physician stated the heart attack was not related to vns. While in the hospital, he had a balloon pump inserted after his heart attack. After the balloon pump was inserted, the patient started experiencing bradycardia happening at 30 second intervals which was the same as vns settings. The physician stated that he had not had arrhythmia prior to his heart attack and attributes the bradycardia happening because the patient had a heart attack and a balloon pump inserted. The physician adjusted settings down in the hospital. The output current was lowered from 3. 0ma, reduced to 2. 5ma. Autostimulation was turned off and magnet mode output current was set to 0ma. The patient died later in the hospital. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5730026
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« Reply #51 on: November 10, 2018, 04:46:18 AM »

Model Number 302-20
Device Problem Fracture
Event Date 06/01/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was found on the patient's vns. It was stated that the patient had a surgery in the past due to a heart attack, but this was not suspected to have damaged the lead. The patient also reported to be having headaches and felt that a difference is the vns therapy being delivered. Follow up with the patient's physician found that the headaches occurred with stimulation and that the patient was also felt stimulation in the jaw. No known surgical intervention has occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7958637
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« Reply #52 on: January 05, 2019, 04:09:23 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/19/2018
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the neurologist was informed that this patient had passed away. The doctor was not in contact with the family, however they were informed by the staff that the patient had a seizure and subsequent myocardial infarction. The doctor stated that there is a high suspicion of sudep and that the patient¿s death is not related to vns. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8146022
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« Reply #53 on: March 02, 2019, 04:43:07 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Manufacturer Narrative

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6569457
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