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dennis100
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« on: May 20, 2014, 05:15:42 AM »

Nothing good happens when the vagus nerve is zapped 30 seconds every 3 or 5 minutes 24/7. The constant abuse will result only in permanent nerve damage. The vagus nerve eventually will be destroyed and you die via vagal inhibition.

Vagal Inhibition
http://healthdrip.com/vagal-inhibition/

The VNS is designed to produce vagal inhibition. Placebo effects are what sell the device. Doctors are aware of that fact. They know what's going on. The VNS is a placebo, a very deadly one. That's all it is folks.

Placebo Effect
http://www.vnsmessageboard.com/index.php/topic,4249.0.html

When death results from vagal inhibition, there are no characteristic postmortem appearances. The cause of death can be inferred only by exclusion of other pathological conditions, and from the accurate observations by reliable witnesses, concerning the circumstance of death.

http://healthdrip.com/vagal-inhibition/


Event Date 05/29/2001
Event Type Injury Patient Outcome Other,Required Intervention
Event Description
An article about the histological appearance of a chronically stimulated vagus nerve in a pediatric reporter indicated vns therapy moderated a patient's atonic episodes, but the patient experienced "occasional hospitalizations for status epilepticus. " the patient passed away due to asphyxiation (reported on medwatch 1644487-2008-02703). The vns therapy system was explanted with "1. 5 cm of unstimulated nerve superiorly and inferiorly. " the electrodes were dissected from the nerve "revealing grossly normal nerve above and below the stimulator. " "abundant inflammatory cells were present around the stimulated nerve section. " "severe myelin loss and occasional myelin digestion chambers were seen in the nerve fibers. With modified trichrome and luxo fast blue stains, this loss was estimated to be nearly 90%. " good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1241164

More
http://www.vnsmessageboard.com/index.php/topic,4142.0.html
« Last Edit: October 14, 2014, 11:13:12 AM by dennis100 » Logged
dennis100
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« Reply #1 on: May 20, 2014, 05:47:09 AM »

Nervus vagus belongs to parasympathetic nervous system which inhibits the contraction of heart, decreases its excitability and frequency of generated nerve impulses in heart. By overstimulating n.vagus these effects on heart are more intense - it could lead to total inhibiton of heart contractions, which would eventually lead to death within a little while.

Very intense slap behind ear or intensive pressure on neck area could lead to death as n.vagus is overstimulated. It is very rare though.

http://wiki.answers.com/Q/How_can_damage_to_the_vagus_nerve_cause_immediate_death
« Last Edit: May 20, 2014, 05:50:52 AM by dennis100 » Logged
dennis100
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« Reply #2 on: May 20, 2014, 05:49:55 AM »

Vagal inhibition
May 31, 2012 | Filed under: Forensic Medicine,General Health | Posted by: admin

Vagal inhibition is condition that causes sudden death to occur within seconds or a minute or two due to minor trauma or relatively simple and harmless peripheral stimulation.
 
Pressure on the baroreceptors situated in the carotid sinuses, carotid sheaths, and the carotid body (located in the internal carotid artery just above the bifurcation of common carotid artery, and situated about the level of angle of mandible) causes an increase in blood pressure in these sinuses with resultant slowing of the heart rate, dilatation of blood vessels and a fall in blood pressure. The vagal inhibition leaves the person dead instantly.
 
In normal persons, pressure on the carotid sinus causes minimal effects with a decrease in heart rate of less than six beats per minute, and only a slight reduction (less than 10 mm. Hg) in blood pressure. Some individuals show marked hypersensitivity to stimulation of the carotid sinuses, characterized by bradycardia and cardiac arrhythmia ranging from ventricular arrhythmias to cardiac arrest.
 
vagal inhibition

Stimulation of the corotid sinus baroreceptors causes impulses to pass via Herring nerve to the afferent fibers of the glossopharyngeal nerve (9th cranial nerve) ; these in turn link in the brain stem to the nucleus of the vagus nerve (10th cranial nerve) causing the vagal inhibition.
 
Parasympathetic efferent impulses then pass to the heart via the cardiac branches of the vagus nerve. Stimulation of these fibers causes a profound bradycardia. This reflex arc is independent of the main motor and sensory nerve pathways. There is wide network of sensory nerves in the skin, pharynx, glottis, pleura, pentoneum covering viscerr or extending into the spermatic cord, cervix, urethra, perineum and coeliac plexus.
 
Afferent fibers from these tissues pass into the lateral tracts of the spinal cord, effect local reflex connections over several segments and also pass to the brain. The vagal nucleus is controlled by the synaptic connections in the spinal cord, which may be facilitated from both the sensory central cortex and from the thalamic centres. The latter may be responsible for emotional tone noted in the vagal reflex.
 
Parasympathetic stimulation of the heart can be initiated by high neck compression, pressure on carotid sinus or sometimes by direct pressure over the trunk of the vagus nerve.
 
Causes of vagal inhibition
 
(1) The commonest cause of such vagal inhibition is pressure on the neck particularly on the carotid sinuses as in hanging or strangulation.
 
(2) Unexpected blows to the larynx, chest, abdomen and genital organs.
 
(3) Extensive injuries to the spine or other parts of the body.
 
(4) Impaction of food in larynx or unexpected inhalation of fluid into the upper respiratory tract.
 
(5) Sudden immersion of body in cold water.
 
(6) The insertion of an instrument into the bronchus, uterus, bladder or rectum.
 
(7) Puncture of a pleural cavity usually for producing a pneumothorax.
 
(8 ) Sudden evacuation of pathological fluids, e.g., ascitic or pleural.
 
(9) Sudden distension of hollow muscular organs, e.g., during attempts at criminal abortion, when instruments are passed through the cervix or fluids are injected into the uterus.
 
(10) In degenerative diseases of the heart, e.g., sinus bradycardia and partial or complete A-V block; parasympathetic stimulation further depress the heart rate and may induce a Stokes-Adams attack which may be fatal. There is great variation in individual susceptibility.
 
Death from vagal inhibition is accidental and caused by microtrauma. The stimulus should be sudden and abnormal for the reflex to occur. The reflex is exaggerated by a high state of emotional tension, and also any condition which lowers voluntary cerebral control of reflex responses, such as a mild alcoholic intoxication, a degree of hypoxia or partial narcosis due to incomplete anesthesia.
 
Autopsy
 
When death results from vagal inhibition, there are no characteristic postmortem appearances. The cause of death can be inferred only by exclusion of other pathological conditions, and from the accurate observations by reliable witnesses, concerning the circumstance of death.
 
A soldier was dancing with his girl friend in the presence of many others in a hall. While dancing, he playfully ‘tweaked” (pinched) her neck. She dropped down dead on the spot. There were no injuries or signs of asphyxia. Death was as a result of vagal inhibition.
 

Related Posts:
•Sudden death
•Modes of death – Asphyxia, Coma and Syncope
•Syncope (fainting) – causes, symptoms and treatment
•Anticholinergic syndrome
•Brain stem death


http://healthdrip.com/vagal-inhibition/

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dennis100
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« Reply #3 on: May 21, 2014, 01:45:05 AM »

Why did FDA approve the VNS when premarket studies showed an effectiveness rate no better than what is expected from a placebo?

A medical device that actually worsens the condition in 1/3 of it's recipients.



1997 FDA CDHR Neurological Devices Panel

DR. COSTELLO: Good afternoon, Dr. Wilkinson and members of the panel. This afternoon, I will be discussing issues regarding the safety and effectiveness of the vagus nerve stimulation device......................One-third of the patients had some type of an increase in seizures, with 17 percent having greater than a 25 percent increase.................This slide shows each of the studies and the percent seizure increase. As you can see, in each of the studies, there were patients who had greater than a 100 percent increase. In the E05 study, the range went up to a 234 percent increase, while in the E04 study, it went even higher, to a 680 percent maximum range.

pg. 125
http://www.fda.gov/ohrms/dockets/AC/97/transcpt/3299t1.pdf


The next issue which I would like to address is the long-term data. As can be seen in the extension phase of the XE5 study, here are the results of the randomized, controlled trial and then followup at 4, 6 and 9 months. Both the mean percent change and the median percent change during the extension phase showed approximately a 30 percent seizure reduction for these patients. However, this data is confounded by the fact that the patients were changing their medications during this period.

Similarly, despite optimal antiepileptic drug therapy, only 20 percent of the patients in the extension phase, using a last visit carried forward analysis, had 50 percent or greater reduction in seizures. One-third of the patients had some type of an increase in seizures, with 17 percent having greater than a 25 percent increase.

pg. 130
http://www.fda.gov/ohrms/dockets/AC/97/transcpt/3299t1.pdf


1650 increase/worsening seizure reports
http://www.vnsmessageboard.com/index.php/topic,4117.0.html

The FDA should not approve a medical device that only makes matters worse for 1 in 3.
« Last Edit: June 01, 2014, 03:59:43 PM by dennis100 » Logged
dennis100
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« Reply #4 on: May 21, 2014, 02:18:09 AM »

Why does intraoperative lead testing effect cardiac function?

Event Date 03/03/2008
Event Type Injury Patient Outcome Other;
Event Description
Initial reporter indicated that during surgery to replace a pt's generator, the pt experienced five episodes of asystole. The events resolved spontaneously without intervention. The events corresponded to the generator on time. The generator was programmed off and the events resolved. The pt at their postop visit had the generator programmed onto a lower setting and did not have a reoccurrence of the asystole event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1021157
More
http://www.vnsmessageboard.com/index.php/topic,3842.0.html

Could the reasoning behind the lead test be to ensure the electrodes are at the correct spot to kill us? Check out the bozos in the report below.

Model Number 105
Event Date 04/28/2014
Event Type Injury Patient Outcome Required Intervention
Manufacturer Narrative
Event Description
It was reported that during the patient's initial implant surgery on (b)(6) 2014, there were difficulties identifying the nerve due to a structure with a similar appearance. Therefore, following placement of the electrodes on the structure believed to be the vagus nerve, the patient¿s generator was programmed on (output current - 2ma) in an attempt to induce bradycardia and therefore identify if the electrodes were indeed on the vagus nerve. Bradycardia was observed as intended and resolved without intervention. Therefore, it was concluded that the electrodes were properly placed. The generator was inadvertently not programmed off after the tests were completed due to communication difficulties with the programming system. As a result, the patient experienced painful stimulation, neck muscle spasms, and severe coughing until the surgeon programmed the patient's generator off and administered morphine the following day.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3825172


They have to get those electrodes on the structure that effects cardiac activity. The VNS wouldn't be able to do it's job if it was on that look alike structure.


That explains why most surgeons continue on with the surgery after the lead test effects cardiac function. It also explains why the FDA is doing absolutely nothing about it.


When death results from vagal inhibition, there are no characteristic postmortem appearances. The cause of death can be inferred only by exclusion of other pathological conditions, and from the accurate observations by reliable witnesses, concerning the circumstance of death.

http://healthdrip.com/vagal-inhibition/
« Last Edit: Today at 02:25:58 PM by dennis100 » Logged
dennis100
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« Reply #5 on: May 21, 2014, 02:19:32 AM »

Why are people collapsing upon activation or change in programming?

Model Number 101
Event Date 05/02/2005
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that after increasing programmed parameters, the pt experienced a choking sensation. During the episode, the pt's eyes became dilated and pt passed out. Treating neurologist was unable to get a pulse for a short period of time, but reported that the pt regained consciousness after prgrammed settings were reduced to original parameters. The pt was sent home in good condition after resting in the doctor's office. It was reported that programmed parameters were increased due to an increase in seizures activity; however, investigation to date has been unable to determine whether the increase was above pre-vns baseline frequency. At follow-up office visit two days later, device diagnostic testing with within normal limits, indicating proper device function. Normal mode output current was reduced from 1. 25ma to 1. 0ma.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=613869

Event Date 01/07/2011
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
It was reported that the pt went to the clinic to have the vns turned on. The pt was programmed to 0. 25 ma and could feel stimulation. When the nurse left the room for a few minutes, the pt's parent alerted that the pt had collapsed on the floor, was non-responsive and chalky white. The nurse thought this may have been due to the vns and turned the device off. The pt was resuscitated and transferred to intensive care unit and now reported to be recovering. The pt's heart rate after device switched off and during resuscitation was 60 bpm. There are no further plans to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1979719
« Last Edit: May 23, 2014, 10:49:09 AM by dennis100 » Logged
dennis100
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« Reply #6 on: May 21, 2014, 02:20:21 AM »

Why are people dying upon activation or change in programming?

Event Date 03/28/2007
Event Type Death Patient Outcome Other;
Event Description
Reporter indicated that a vns pt expired. The pt had been seen by her treating physician for initial vns therapy system dosing the day prior to having expired. There was probable cause to believe it was due to sudep (sudden unexplained death in epilepsy).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=841027

Model Number 103
Event Date 01/14/2011
Event Type Death Patient Outcome Death
Event Description
It was reported that the vns patient passed away on (b)(6) 2011. The patient was doing well with vns. She came into the physician's office for a routine adjustment which she tolerated well the day prior to her death. She had a seizure the next day and the parents used the magnet and stopped the seizure. Later that night, the patient died suddenly. Clinic notes dated (b)(6) 2011 were received which indicated that the patient had increase in seizures related to her menstrual cycle, so the mother planned to visit an ob/gyn so that the seizure may improve. The vns magnet was able to alleviate the seizure when caught early. The mother reported her seizures had been occurring approximately eight times per month at a duration of one minute. An addendum note was written by the nurse practitioner indicating the mother reported the patient's passing the following day. The patient had a seizure at 1:00am, and the mother used the vns magnet which stopped the seizure. At 3:00am, she was alert and responsive. At 7:00am when the mother attempted to wake the patient, she was unresponsive. Her brother attempted cpr, and medical personnel were called but the patient was unable to be resuscitated. Based on the clinical information, the nurse noted that it appears that her death may have been sudep-related. The death follow up form was completed which revealed that vns therapy helped reduce the patient's seizures. She was receiving vns therapy at the time of death, and the believed cause of death was sudep. The death is not believed to be related to vns therapy. The patient has a history of nocturnal and febrile seizures, in which the onset of epilepsy occurred at the age of two. The patient suffered from generalized primary seizures. There was no history of cardiac or respiratory problems or drug/alcohol abuse. The patient was compliant with anti-epileptic drugs at the time of death. Follow up with the funeral home revealed that the devices are not believed to have been explanted prior to burial on (b)(6) 2011.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2749977

Model Number 103
Event Date 07/10/2013
Event Type Death Patient Outcome Death
Event Description

It was reported that the patient's settings were increased from an output current of 1. 5ma to 1. 75ma, and that the patient passed away the next day. Per the initial reporter, the patient passed away from cardiac arrest/seizure related. This physician believes that it was sudep, but this was not confirmed. The physician did not specify if there was a relationship between the death to vns and did not provide any additional information. Follow up with the patient's treating neurologist found that he was unaware of the circumstances surrounding the patient's death and did not know the cause or relation to vns. He stated that it occurred the day after the patient's settings were changed; however, could not comment on if there was a relationship or not. The patient's body was cremated and no autopsy was performed. Follow up with the funeral home found that they could not confirm if they still had the patient's vns device and would not be able to return it to the manufacturer. No other information has been provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3298903

Event Date 02/17/2010
Event Type Death Patient Outcome Death;
Event Description
My daughter, (b)(6) , had a vns implanted on (b)(6) 2010. She went to her neurologist on (b)(6) 2010 and had the device turned on. She died suddenly on (b)(6) 2010. It is my belief that this device was responsible for her death. The medical examiner removed the vns during the autopsy and sent it back to the mfr for diagnostics. I asked the medical examiner if i could have the device and i was told no. I asked that the device be sent to a third party that was not involved since i was not allowed to take the unit myself. The mfr is cyberonics. The serial number is: (b)(4), generator number: 17876 and lead number 302. I do not know what cyberonics did with my daughter's device nor have i ever received any info with any findings. It is my belief that the vns caused her heart to stop. She meant everything to me and she died leaving 2 children who were only 5 months and 15 months old. It is my hope that this device be removed from the market. I do not care how many have benefited from use of it, because no amount of good results are ever worth someone's life. We were not even told that there was a risk of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2002813
« Last Edit: May 23, 2014, 10:50:05 AM by dennis100 » Logged
dennis100
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« Reply #7 on: May 21, 2014, 02:21:09 AM »

Why are hearts slowing down?

Event Date 01/01/2009
Event Type Injury Patient Outcome Required Intervention; Hospitalization
Event Description
It was reported that a pt developed drop attacks in 2009 (approximately 7. 5 years after being implanted which lead to the pt being hospitalized. The pt also had periodic bradycardia. The device was programmed off and the bradycardia and drop attacks resolved. Additional information received from the pt's physician revealed that the pt does not have a history or a family history of cardiac events. The pt presented with syncope which suggested some sort of arrhythmia. The pt's heart rate prior to the event was 70 and decreased to 10 during the event. The blood pressure was 120/80 prior to the event; however, no blood pressure readings were provided after the event. There were no traumatic events, medication changes, or triggers such as smoking, caffeine intake, etc. That preceded the onset of the bradycardia. The pt is currently taking zonegran, lamictal, and topamax. The bradycardia did not occur during device diagnostics nor did it occur following a setting change. An ecg and polysomnography were performed to diagnosed the arrhythmia. The arrhythmia (bradycardia) is believed to be related to device stimulation and is exaggerated by the device. The pt was hospitalized for the length of testing needed to diagnose the arrhythmia. The arrhythmia has not recurred since the device has been programmed off. Good faith attempts to obtain additional information are currently being made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1558273

Got 142 more of those.
http://www.vnsmessageboard.com/index.php/topic,3850.0.html
« Last Edit: May 23, 2014, 10:50:57 AM by dennis100 » Logged
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« Reply #8 on: May 21, 2014, 02:21:49 AM »

Why are hearts racing?

Event Date 11/08/2002
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indcated that patient had to go to the emergency room in 2002 because of increased heart rate (230 beats per minute) that caused pt to pass out. The patient's ncp system was programmed to on approximately 3 weeks post-implant but was programmed to off in 2002 during pt's emergency room visit. The patient was discharged from the hospital that same night and has reported no further cardiac problems since the device was programmed to off. There have not been any recent medication changes and the patient reports that they did not do anything out of the ordinary on the day of their emergency room visit. Further follow-up revealed that the patient's device was programmed back to on. The physician indicated that the patient is fine and has had no recurrence of tachycardia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=432838

84 more
http://www.vnsmessageboard.com/index.php/topic,3862.0.html
« Last Edit: May 25, 2014, 01:14:34 PM by dennis100 » Logged
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« Reply #9 on: May 21, 2014, 02:22:41 AM »

Why are hearts stopping?

Event Date 03/03/2008
Event Type Injury Patient Outcome Required Intervention
Event Description
Initial reporter called to ask if manufacturer had any info on vns pt's experiencing asystole caused by swiping their magnet or stimulation. It was additionally reported "a pt had a seizure and the nurse swiped with a magnet. Afterwards the pt went into asystole, which lasted several seconds. The pt was in the hospital due to seizures and connected to a monitor so they were able to see it. " the pt's seizure rate was above their pre vns seizure rate and was a change for the pt. No further info has been attained from the site after good faith attempts have been made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1022608

Got 90 more of those reports.
http://www.vnsmessageboard.com/index.php/topic,3832.0.html
« Last Edit: May 25, 2014, 02:15:46 PM by dennis100 » Logged
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« Reply #10 on: May 21, 2014, 02:23:40 AM »

Why are cardiac pacemakers being implanted instead of just turning the VNS off?

Event Date 09/04/2009
Event Type Injury Patient Outcome Hospitalization;
Event Description
Reports indicated a vns therapy patient was admitted to the hospital for bradycardia and was in the ccu. The cardiologist feels that the patient's bradycardia may be related to his vns. Additional information received indicated the physician originally believed the vns may have had something to do with the bradycardia and wanted to turn it off but later decided the patient still needs a pacemaker. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1491034

Got 70 more of those reports.
http://www.vnsmessageboard.com/index.php/topic,4011.0.html
« Last Edit: May 25, 2014, 02:16:57 PM by dennis100 » Logged
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« Reply #11 on: May 22, 2014, 05:40:24 AM »

Why are people dropping dead?

Event Date 03/25/2004
Event Type Death Patient Outcome Death;
Event Description
Reporter indicated that vns patient had passed away. It was reported that the patient was walking into a room and simply dropped dead. Treating neurologist indicted that the death may be cardiac-related, but is not sure as autopsy results are pending. Cause of death is not known at this time. There is no evidence at this time that the ncp system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522043

Model Number 102
Event Date 11/01/2012
Event Type Death Patient Outcome Death
Event Description

It was reported that the patient passed away. The date of death was found to be (b)(6) 2012. It was indicated that the patient just "happened to fall and die". Attempts for additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2861339
« Last Edit: May 28, 2014, 02:21:47 AM by dennis100 » Logged
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« Reply #12 on: May 23, 2014, 01:53:12 AM »

Why can't they wait for a surgeon?

Model Number 100
Event Date 08/27/1999
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Although the pt was receiving a reduction in seizures, she requested the device be removed. She stated that the stimulation "bothered her. " her physician scheduled an appointment to make some adjustments to her device. Subsequently, the pt took some sterile equipment from an area hosp and removed the device at home. The pt was instructed by her neurologist to go to the emergency room. The pt's wound was treated in the emergency room; a drain was put in place, and the wound was stitched.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=241087

Model Number 101
Event Date 01/11/2002
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
Rptr indicated that pt had explanted self. It was reported that the pt went into the restroom and when the pt came out, the generator was out of the pt's chest. The pt opened the healed incision. The pt had apparently pried the generator out with the pt's hands. The pt picked at it until the pt got it out. The pt's lead was explanted by surgeon and the pt was prescribed a prophylactic ten-day dose of amoxicillin. There are no plans for re-implant. Further f/u revealed that the pt was seen in 2002 at which time the pt's staples were removed and the pt was reported to be healing fine from the explant procedure. No further appointments are scheduled.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=377618

Model Number 102
Event Date 01/01/2004
Event Type Injury Patient Outcome Required Intervention;
Event Description
Patient's wound dehisced some time after suture removal following implant surgery. The patient was reportedly seen in hospital emergency room, at which time the wound was "sewn back up. " at recent office visit, treating neurologist indicated that he could not palpate the generator. Review of subsequent chest x-ray revealed that no generator was present in the chest along with no evidence of the lead. Investigation to date has been unable to determine the location of the devices or whether the patient removed the lead and/or generator through the incision sites. The patient's family member has reportedly searched their home for the lead and generator with no success. Repeat x-rays and follow up with neurosurgeon are planned. Investigation to date has been unable to determine the cause of the reported wound dehiscence.

http://www.accessdata.fda.gov/scripts/cdrh...RFOI__ID=573008
« Last Edit: May 28, 2014, 09:43:50 AM by dennis100 » Logged
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« Reply #13 on: May 23, 2014, 01:58:41 AM »

Why are VNS doctors and surgeons losing their license to practice medicine?

Model Number 102
Event Date 04/01/2005
Event Type Injury Patient Outcome Required Intervention
Event Description
It was noted in (b)(6) 2005 that the patient was going to undergo repositioning surgery to have it moved closer to the skin surface so the generator could be communicated with. No additional relevant information has been received to date. It was noted that the patient's neurologist and surgeon are no longer in practice.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3759661

Hey, my VNS doc is no longer in practice. Just a funny coincidence I guess.

Model Number 102
Event Date 01/01/2014
Event Type Malfunction
Event Description
The patient's husband reported that the patient's depression has returned and they are unsure if the device is working. The patient's physician went out of business and the patient and husband are looking for a new physician to check the vns. The patient's husband reported that the device was last checked about six months ago. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3800731
« Last Edit: September 21, 2014, 12:32:41 AM by dennis100 » Logged
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« Reply #14 on: May 23, 2014, 08:26:28 AM »

Why has the FDA allowed over 470 VNS deaths to go unexplained?.
Reports like this one.

Event Date 02/23/2000
Event Type Death Patient Outcome Death;
Event Description
Pt found dead in bed. Known epileptic. Had vagal nerve stimulator implanted in 1999.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=276090


470 other ones.
http://www.vnsmessageboard.com/index.php/topic,3840.0.html
« Last Edit: May 28, 2014, 12:20:36 PM by dennis100 » Logged
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« Reply #15 on: May 23, 2014, 10:57:48 AM »

Why hasn't the FDA taken action?

« Last Edit: May 25, 2014, 01:21:17 PM by dennis100 » Logged
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« Reply #16 on: May 25, 2014, 01:22:45 PM »

The FDA has taken no action because the FDA feels there is no need to act. Why fix something that ain't broke? The VNS is performing exactly as it was designed to perform. Providing stimulation to bring on vagal inhibition.

The FDA has been very pleased with the results seen from vagal nerve stimulation technology. As a matter of fact the FDA has been so pleased they plan on expanding the indications of use to include other medical conditions. The VNS won't just be for treatment resistant epilepsy and treatment resistant depression anymore.

Once a medical device has FDA approval it then becomes part of the protocol for the condition it was approved for. Doctors are free though to prescribe a FDA approved device for just about anything they wish. The term is off-label use.


Other possible uses.
http://www.vnsmessageboard.com/index.php/topic,3933.0.html


examples

Alzheimer's Disease
http://www.ncbi.nlm.nih.gov/pubmed/12444809

Burn-induced organ dysfunction
http://www.ncbi.nlm.nih.gov/pubmed/19482432

Comorbid Personality Disorders
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01119053

Gut injury and lung permeability in trauma-hemorrhagic shock
http://www.ncbi.nlm.nih.gov/pubmed/22846937

Inhibits heroin seeking behavior in rats
http://www.ncbi.nlm.nih.gov/pubmed/21362452

Medication-refractory mental illness
http://www.ncbi.nlm.nih.gov/pubmed/12059125

Mood disorders in elderly population
http://www.ncbi.nlm.nih.gov/pubmed/19519563

Traumatic brain injury
http://www.ncbi.nlm.nih.gov/pubmed/22695423

Vaginal-Cervical self-stimulation in women with complete spinal cord injury
http://www.ncbi.nlm.nih.gov/pubmed/15451368

« Last Edit: September 16, 2014, 10:17:30 PM by dennis100 » Logged
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« Reply #17 on: May 26, 2014, 01:20:43 AM »

VNS in Reader's Digest

http://www.newamerica.net/node/35911
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« Reply #18 on: May 26, 2014, 03:29:26 AM »

Back in 1997 the FDA scientists were "OK" with ridding the country of treatment resistant epilepsy. That figures, no one seems to like our kind anyway. Boy did those scientists raise a fuss in 2006 when they voted against eradicating treatment resistant depression but were overrode by the head honcho of the device division. That guy didn't want any more treatment resistant depression in this country. Those scientists were angry because they didn't mind the treatment resistant depressed people so much. Treatment resistant epilepsy was the only thing they wanted to get rid of. I heard they even wrote to Obama claiming corruption within the FDA. I wish someone would stand up for us like that.


Top FDA Official Approves Medical Device Despite Lack of Efficacy
Union of Concerned Scientists

In an extraordinary move, a top Food and Drug Administration (FDA) official approved a medical device against the unanimous opinion of his scientific staff in February 2006. Dr. Daniel G. Schultz, FDA's Director of the Center for Devices and Radiology and Health, approved a surgically implanted vagus nerve stimulator for treatment of cases of severe depression even though, as reported in the New York Times, the device "had not proved effective against depression in its only clinical trial for treatment of that illness."¹

FDA scientists "repeatedly and unanimously" recommended rejecting approval of the device, manufactured by Cyberonics, as a depression treatment, though at one point an advisory panel did provisionally recommend approving the device. An investigation by the Senate Finance Committee found that Dr. Schultz had overruled more than twenty FDA officials who recommended against approval.² According to the New York Times, the decision represented the first time in the agency's history that a director "approved a device in the face of unanimous opposition from staff scientists and administrators beneath him."³

The vagus nerve stimulator is surgically implanted into the base of the neck and sends electrical signals to the heart, brain and other parts of the body.4 The device was approved as a treatment for epilepsy in 1997. The company requested FDA approval for treating cases of severe depression after some device recipients reported improved moods. Anecdotal evidence suggesting that the nerve stimulator could help seriously depressed patients did not hold in clinical research. The one comprehensive study of the device in clinically depressed patients failed to show convincingly that the device had any positive effect on the patients.5 Critics have detailed how, following the initial failed trial, Cyberonics has "relied upon a series of non-randomized, unblinded studies with questionable control groups to make its claim for the effectiveness of the device."6 In short, Cyberonics never proved its device to be safe and effective, as is required by the FDA.

By overruling his scientific advisors, Dr. Schultz set in motion a potential windfall for Cyberonics. Public Citizen reported that the market for patients with epilepsy using the device was approximately 30,000, but the potential market for sufferers of treatment-resistant depression was over 4,000,000. The FDA defended the apparatus' approval as a means for helping those with severe depression who "are otherwise on their way to institutionalization, because of the seriousness of their illness."7

The New York Times, however, reported that FDA reviewers were "bewildered" by the decision. As one agency scientist said, "in my opinion, they do not have adequate data, and I don't understand how this can move forward." Another scientist argued that approval of the device was "akin to approving an experimental product."8

Dr. Peter Lurie, deputy director of Public Citizen's Health Research Group, argues that the FDA needs to relearn a simple principle: "If it doesn't work, it shouldn't be approved."9



http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CGEQFjAA&url=http%3A%2F%2Fwww.ucsusa.org%2Fscientific_integrity%2Fabuses_of_science%2Fnerve-stimulator.html&ei=CCCrT66kAcno2AXBvOzABg&usg=AFQjCNGCok493kDnSuGouYVkH1_Ke3PWFA
« Last Edit: June 01, 2014, 07:19:20 AM by dennis100 » Logged
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« Reply #19 on: May 27, 2014, 02:20:37 AM »

Scientists' Letter Claiming FDA Corruption Is Authentic
by Heidi Stevenson

16 March 2010
Pig Pharma mother pig suckling FDA baby pigs

In January last year, a letter was sent to the highest levels of United States government by FDA scientists and doctors accusing top FDA officials and attorneys of violating laws, suppressing and altering scientific findings and conclusions, abuse of power and authority, and retaliation against those who've spoken out. The FDA has finally acknowledged that the letter is authentic.

The public's health is at risk. Those of us who follow the FDA's rulings are aware of its inconsistencies and approvals based on severely flawed science. This letter, though, documents some of the incidents and names people involved. The names go to the very top of the agency, including the commissioner. It's been well over a year. So far, all that appears to have been accomplished is verification of the fact that it was written by genuine FDA employees.

With the lives of Americans at stake, that simply isn't adequate. This should be treated as one of the nation's highest priorities—and it should be handled in public. Instead, it's quite hush-hush. If anything's happening, there's no way the public would know.

In the meantime, a well-documented corrupt agency charged with securing the safety of medical devices and drugs is being granted—and unilaterally taking—immense power over people's lives. They're determining what can be called a drug, and have gone so far as to state that even soup can be a drug if a health claim is made for it. The FDA is out of control—and though much of its malfeasance has been well documented, it continues to grab and be gifted with power.
What's in the Letter

The letter states:

    America urgently needs change at FDA because FDA is fundamentally broken, failing to fulfill its mission, and because re-establishing a proper and effectively functioning FDA is vital to the health of the nation.

The letter then goes on to quote from the November 2007 FDA Science Board Report:

    'The FDA is also central to the economic health of the nation, regulating approximately $1 trillion in consumer products or 25 cents of every consumer dollar expended in this country annually. ... [Ellipsis is in the letter.] The importance of the FDA in the nation's security is similarly profound. ... [Again, ellipsis is in the letter.] Thus, the nation is at risk if FDA science is at risk. [Emphasis in letter.]

The authors then state the purpose of their letter:

    The purpose of this letter is to inform you that the scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk. Through this letter and your action, we hope that future FDA employees will not experience the same frustration and anxiety that we have experienced for more than a year at the hands of FDA managers because we are committed to public integrity and were willing to speak out. Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around.

The letter goes on to state that the Director of the Office of Device Evaluation (ODE) has:

    Ordered physicians and scientists to ignore FDA Guidance documents.
    Knowingly allowed subordinates to issue written disciplinary actions for failure to change scientific opinions.
    Issued illegal documents that are not publicly available and would circumvent scientific and legal requirements.
    Failed to properly document significant decisions.
    Made and allowed false statements in FDA documents.
    Allowed manufacturers to market unapproved devices.
    Removed Black Box warnings FDA experts recommended.
    Bypassed FDA experts and failed to properly label devices.
    Excluded FDA experts from meetings when manufacturers didn't want them there.

Three specific device approvals referenced were:

    Interference by former FDA chief Andrew von Eschenbach in approval of a knee device.
    A computer-aided mammography device's approval over the unanimous vote against it by all FDA experts after a phone call from Congressman Christopher Shays.
    Daniel Schultz's approval of a device to prevent scar tissue in spite of the scientists' unanimous opinion against it.

Specific names brought up included Commissioner Andrew von Eschenbach and his assistant Commissioner for Accountability and Integrity, Attorney Bill McConagha, the highest level officials of the FDA. von Eschenbach resigned as of Obama's inauguration.

The scientists' and physicians' names have been withheld for their protection.
What Now?

The FDA has now officially acknowledged the existence of the letter and that it came from employees of the agency. It's been well over a year, and that appears to be all that's happened so far. The same writers followed their first letter of January 2009 with another in April 2009. In it, they reemphasized their concerns and broadened them to include the FDA's Center for Drug Evaluation and Research (CDER), pointing out that a federal court had found that a drug had been approved because CDER's top personnel "didn't have a choice". They had to "ignore the science and the law" to approve it or they would "be removed from their positions of authority". They further listed several other incidents.

This is the same FDA that is the final arbiter of vaccine approval. If they approve a vaccine, then no matter how severe its effects—including death and destruction of life's quality—and no matter if the manufacturer was fully aware of the dangers, it is now impossible to sue.

This is the same FDA that is grabbing power, even to the point of taking control of things that are more properly called food, such as supplements, vitamins, and Cheerios (though this author would quibble with the concept of Cheerios as food).

The FDA is out of control—at least, we must hope that's the case. If not, then it's acting according to higher-level instructions. That concept is terrifying to consider. Yet, the apparent lack of action in response to the scientists' and physicians' letter leaves one to question just what is really going on.


http://www.gaia-health.com/articles201/000201-scientists-letter-claiming-fda-corruption-is-authentic.shtml



« Last Edit: May 29, 2014, 01:15:06 AM by dennis100 » Logged
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« Reply #20 on: May 28, 2014, 02:34:38 PM »

Has anyone ever thought about why this deadly device is only indicated for treatment resistant stuff?

You really don't have to think too hard to figure it out.
« Last Edit: June 01, 2014, 03:02:51 AM by dennis100 » Logged
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« Reply #21 on: May 28, 2014, 05:25:55 PM »

Vagal inhibition is such a sneaky way to kill us because there would be no characteristic postmortem appearances after the VNS zapped us to death.

I wonder who came up with that plan. Probably those FDA scientists.
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« Reply #22 on: May 28, 2014, 11:57:53 PM »

What really troubles me is thinking about who gave the order to do that to us.
« Last Edit: June 01, 2014, 01:49:14 AM by dennis100 » Logged
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« Reply #23 on: May 28, 2014, 11:59:38 PM »

It's been going on since 1997.
« Last Edit: June 01, 2014, 01:49:25 AM by dennis100 » Logged
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« Reply #24 on: May 29, 2014, 12:13:21 AM »

Bill Clinton was president.

I never liked that guy.
« Last Edit: June 01, 2014, 01:49:44 AM by dennis100 » Logged
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« Reply #25 on: May 29, 2014, 12:22:09 AM »

If an order was given and a president gave it I pray to God he is not protected by presidential immunity.
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« Reply #26 on: May 29, 2014, 04:12:30 AM »

The surgeons really don't seem to give a damn about how they abuse our bodies. Guess it's because we are the treatment resistant.


Model Number 304-20
Event Date 07/31/2012
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

On (b)(6) 2012, a nurse practitioner reported that the vns patient's leads were implanted on the right vagus nerve instead of the left. On (b)(6) 2012, the surgeon reported that he could not find any place on the left vagus nerve to place the lead, therefore it was placed on the right vagus nerve. They turned on the device shortly after surgery and programmed the patient to an output current of 2. 0 ma and the patient started experiencing more spasms. The patient's output current was then lowered to 0. 25 ma. Then when the settings were increased up a level, the patient started having spasms again. The surgeon stated that he was considering taking the patient back to surgery as he was wondering if the patient's spasms were due to the lead placement. The surgeon then later reported that he did not think he could get another lead on the left side so they went for right side replacement even though he knows the manufacturer's labeling is for left side placement only. With the device on the left side the patient was able to tolerate settings of up to 2. 5 ma. However, once placed on the right side the patient was only able to tolerate a setting of 0. 25 ma. A setting of 0. 5 ma, which is what the magnet mode was set to, resulted in the patient experiencing significant laryngospasms. The patient was not scoped to make sure it was contraction of the laryngeal cord causing the issue and not something else as the surgeon did not think it was necessary since swiping the magnet, set to 0. 5 ma, resulted in significant choking. The nurse stated that the patient immediately had adverse events with stimulation as the patient had been programmed to his original settings of 2. 0ma without giving the nerve a chance to acclimate to the stimulation. The patient is now being titrated up slowly and all his adverse events have stopped. The nurse later reported that after surgery on (b)(6) 2012, was the first time the laryngospasms/coughing were first observed. The nurse believes that it is due to the high stimulation from vns being turned on to 2. 0 ma after surgery. The events occurred with stimulation. Diagnostic results were within normal limits but the specifics were not provided. The patient does not have a medical history of laryngospasms prior to vns. The laryngospasms ceased after turning the settings down.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2713825
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« Reply #27 on: May 30, 2014, 02:43:04 AM »

Minimally conscious or persistently vegetative state. Just stick a VNS in them to make that treatment resistant problem go away.

Vagus Nerve Stimulation to Augment Recovery From Minimally Conscious or Persistently Vegetative States After Traumatic Brain Injury

Traumatic brain injury has a high morbidity and mortality in both civilian and military populations. Blast and other mechanisms of traumatic brain injury damage the brain by causing neurons to disconnect and atrophy. Such traumatic axonal injury can lead to persistently vegetative and minimally conscious states, for which extremely limited treatment options exist, including physical, occupational, speech and cognitive therapies.

More than 50,000 patients have received vagus nerve stimulation for epilepsy and depression. In addition to decreased seizure frequency and severity, patients report enhanced mood, reduced daytime sleepiness independent of seizure control, increased slow wave sleep, and improved cognition, memory, and quality of life.

The purpose of this study is to demonstrate objective improvement in clinical outcome by placement of a vagus nerve stimulator in patients who are recovering from severe traumatic brain injury. Our hypothesis is that stimulation of the vagus nerve results in increased cerebral blood flow and metabolism in the forebrain, thalamus and reticular formation, which promotes arousal and improved consciousness, thereby improving outcome after traumatic brain injury resulting in minimally conscious or persistent vegetative states. If this study demonstrates that vagus nerve stimulation can safely and positively impact outcome, then a larger randomized prospective crossover trial will be proposed.

The investigators will achieve this objective by evaluating whether vagus nerve stimulation impacts clinical recovery from minimally conscious or persistent vegetative states caused by traumatic brain injury as assessed by the FIM™ instrument and Functional Assessment Measure (FIM+FAM) as well as the JFK Coma Recovery Scale Score. The investigators will also evaluate whether vagus nerve stimulation alters resting and activational functional MRI.

Twelve patients will be enrolled in this initial crossover pilot study. These patients will have sustained a severe traumatic brain injury (Disability Rating Scale score of 22 to 29) more than twelve months from starting the study, and have no other concurrent active severe medical problems. Baseline EEG and magnetic resonance imaging (MRI) will be performed prior to left vagus nerve stimulation implantation. Patients will be randomized to alternating three month periods with the device on or off. Outcomes will be assessed at three month intervals with the FIM™ instrument and Functional Assessment Measure (FIM+FAM) and JFK Coma Recovery Scale by a neuropsychologist blinded to the status of the device. Outcomes will also be assessed using quantitative eye movement tracking and functional magnetic resonance imaging. Patients will cross over every 3 months and be followed for at least 18 months.

Study Type: Interventional
Study Design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Study Primary Completion Date: July 2013

http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01260090
« Last Edit: May 31, 2014, 02:15:23 PM by dennis100 » Logged
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« Reply #28 on: May 30, 2014, 02:44:15 AM »

The FDA knew 15 years ago the VNS could be deadly.

Model Number 100
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Event Description
Pt had a cyberonics vagal nerve stimulator implanted 2 wks ago. Stimulator turned on 10/18/1999. Pt had an acute mi 3-4 hrs later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=245555
« Last Edit: June 01, 2014, 01:50:39 AM by dennis100 » Logged
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« Reply #29 on: May 30, 2014, 07:27:12 PM »

A good description of what your vagus nerve will look like after you have been zapped to death.

Event Date 05/29/2001
Event Type Injury Patient Outcome Other,Required Intervention
Manufacturer Narrative
Article: histological appearance of chronically stimulated vagus nerve in a pediatric patient. Pediatr neurosurg 2001, 35:99-102 2001 r shane tubbs. Et al.
Event Description
An article about the histological appearance of a chronically stimulated vagus nerve in a pediatric reporter indicated vns therapy moderated a patient's atonic episodes, but the patient experienced "occasional hospitalizations for status epilepticus. " the patient passed away due to asphyxiation (reported on medwatch 1644487-2008-02703). The vns therapy system was explanted with "1. 5 cm of unstimulated nerve superiorly and inferiorly. " the electrodes were dissected from the nerve "revealing grossly normal nerve above and below the stimulator. " "abundant inflammatory cells were present around the stimulated nerve section. " "severe myelin loss and occasional myelin digestion chambers were seen in the nerve fibers. With modified trichrome and luxo fast blue stains, this loss was estimated to be nearly 90%. " good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1241164
« Last Edit: June 01, 2014, 01:50:53 AM by dennis100 » Logged
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