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dennis100
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« on: January 25, 2015, 03:51:00 AM »

Model Number 103
Event Date 01/09/2014
Event Type Injury Patient Outcome Other
Manufacturer Narrative

Event Description
The patient was successfully implanted on (b)(6) 2014, with a vns system. Two system diagnostic tests (one out-of-pocket and one in-pocket) indicated the device was within normal limits. Final interrogation confirmed the output and magnet currents were both set to 0. 0 ma. During the first system diagnostic test, the anesthesiologist stated there were a few seconds of missed heartbeats with normal rhythm resuming after the vns stimulation stopped. No intervention was performed. Both the surgeon and anesthesiologist stated this was due to the vns stimulation and the patient had no known pre-existing cardiac conditions. The surgeon proceeded with the surgery and inserted the vns generator inside the chest pocket. A second system diagnostic test was then performed with normal results and no abnormal cardiac activity noted. The surgeon was asked if he was planning to inform the neurologist of this occurrence and he stated that since there was no abnormal activity noted on the second diagnostic, he did not think it was an issue and was not planning to contact the neurologist. He stated if there was abnormal activity on both diagnostic tests, he would definitely inform the neurologist. No additional information was provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3604263

more
http://www.vnsmessageboard.com/index.php/topic,3842.0.html

Why it is important for the neurologist to know those kind of things:

Event Date 01/01/2006
Event Type Injury Patient Outcome Required Intervention
Event Description
Vns pt was hospitalized with asystole. While hospitalized, the pt's device was programmed to off, after which his condition stabilized. While attempting to reinitiate device stimulation, the pt exhibited asystole again. Treating physician programmed the device back to off and does not plan to reinitiate stimulation. The pt had reportedly been experiencing good seizure control with the vns therapy and his device had been programmed to 3. 0ma normal mode output current "for quite a while". It was reported that since the incident, the pt is unable to tolerate even lower levels of stimulation, due to the cardiac condition. The pt is non-verbal and cannot communicate whether device stimulation feels abnormal. The pt does not have any pre-existing conditions that may have precipitated the reported event and there had been no recent changes to the pt's medication regimen.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=675911

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

Event Date 01/10/2006
Event Type Injury Patient Outcome Required Intervention
Event Description
Reporter indicated that pt suddenly began to experience serious drop attacks unrelated to his epilepsy. The pt had been implanted for approx 29 months when the drop attacks began and had experienced good efficacy with the vns therapy regarding his seizure control. There had been no changes to either programmed parameters or medication regimen for approx one year. The pt was hospitalized, during which time it was discovered that he was experiencing episodes of bradycardia leading to asystole during device stimulation cycles. The pt also experienced several episodes of syncope during this time. No heart condition has been reported that the pt's device was functioning normally, although specific device diagnostic test results were not provided by physician. Stimulation has been discontinued and explant of the ncp system is planned. The episodes of syncope have reportedly resolved since the device was programmed to off; however the pt's seizures have somewhat worsened in the absence of the vns therapy (to approx 1 seizure per wk). Treating physician indicates that the reported events appear to be related to device stimulation ("vagally-induced heart block and sinus bradycardia") but does not know why the pt began to experience these events after more than two yrs of successful vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=689307

more reports
http://www.vnsmessageboard.com/index.php/topic,3832.0.html

Reader's Digest article
http://www.vnsmessageboard.com/index.php/topic,4490.0.html
« Last Edit: February 02, 2015, 04:20:47 PM by dennis100 » Logged
dennis100
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« Reply #1 on: February 01, 2015, 05:49:27 PM »

We know it can stop your heart from beating. If we know it, that means the FDA knows it because those are their reports. Why haven't they recalled the VNS?

Perhaps the better question would be:

Why did the FDA put their seal of approval on a medical device that worsens the condition in one third of it's recipients?

1997 FDA CDRH 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

more
http://www.vnsmessageboard.com/index.php/topic,3944.0.html

The best question would have to be:

How can damage to the vagus nerve cause immediate death?

Cardiovascular Health Questions
Answers.com>Wiki Answers>Categories>Health>Cardiovascular Health

Best Answer

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

more
http://www.vnsmessageboard.com/index.php/topic,4499.0.html

« Last Edit: February 02, 2015, 02:20:56 PM by dennis100 » Logged
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