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dennis100
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« on: August 03, 2010, 10:53:47 PM »

Health Drip.com
A Complete Health E-Guide

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/

______________________________________________________________________________

1997 FDA CDRH Neurological Devices Panel

DR. PIANTADOSI: Could I just ask the FDA very directly--I'm not confused about what the company thinks, and I really am not interested in the nuances of how SUDEP is defined. Is the FDA satisfied that this device is not associated with an elevated risk of death, all-cause mortality, whatever you want?
 
DR. COSTELLO:............So, to answer your question, I don't believe it has been shown that the high death rate is directly related to the device. However, we only have 2,000 patient years of  experience and a limited number of patients...............I cannot say that I believe that there is an  increased risk right now, but I would not want to rule it out either. I think that would require a longer-term study.
 
Pg. 142
http://www.fda.gov/ohrms/dockets/AC/97/transcpt/3299t1.pdf

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................................ ........ ...

In terms of the E03, E04 and E05 studies, one patient in the E05 study dropped out due to a left hemidiaphragm paralysis. It is thought that this is due to an anatomical anomaly in the area of the vagus nerve. One patient in the E03 study dropped out due to left vocal cord paralysis. This was due to a generator malfunction which has since been corrected, and this adverse event has not reoccurred. One patient suffered a myocardial infarction and decided to withdraw from the study.


pg.131
http://www.fda.gov/ohrms/dockets/ac/97/transcpt/3299t1.pdf

 
The VNS was approved 19 days after this panel met.

 
« Last Edit: September 05, 2014, 12:11:37 AM by dennis100 » Logged
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« Reply #1 on: August 03, 2010, 10:54:55 PM »

Event Date 04/01/2005
Event Type Death Patient Outcome Death;
Manufacturer Narrative
Approx 21 months prior to death, the pt experiened shortness of breath, constant chest pain, and palpitations following an increase in programmed parameters. The symptoms reportedly subsided when device parameters were reduced to pre-symptomatic levels. Reference medwatch report 1644487-2003-00482.

Event Description
Mfr periodically compares device-tracking info to the social security death index for the purpose of updating device-tracking data. During this process, mfr became aware of a pt death. Certifcate of death was requested, received and reviewed by mfr. Death certificate indicates that the pt died at his residence. Immediate cause of death is listed as sudden cardiopulmonary failure. Autopsy was not performed. Investigation to date has been unable to determine whether the reported event was related to the vns therapy system as the identity of the pt's last known treating physician is unk. There is no evidence that the vns therapy system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=678928

« Last Edit: October 09, 2013, 08:45:34 PM by dennis100 » Logged
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« Reply #2 on: August 03, 2010, 10:55:56 PM »

Event Date 01/01/2002
Event Type Death Patient Outcome Death;
Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. The death certificate listed the immediate cause of death as cardio pulmonary arrest, due to (or as a consequence of) cardiac arrhythmia.

Event Description
Reporter indicated that vns pt had passed away. Exact date and cause of death are unk 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=460588



« Last Edit: October 09, 2013, 08:45:58 PM by dennis100 » Logged
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« Reply #3 on: August 04, 2010, 06:33:03 AM »

Event Date 07/30/2002
Event Type Death Patient Outcome Death;
Manufacturer Narrative
H. 6. Method: device mfg records were reviewed. Results: review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance.

Event Description
Reporter indicated that "vns" patient passed away from cardiac arrest. An autopsy is not planned. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=414229

« Last Edit: October 09, 2013, 08:46:17 PM by dennis100 » Logged
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« Reply #4 on: August 05, 2010, 11:14:31 AM »

Event Date 07/19/2003
Event Type Death Patient Outcome Death;
Manufacturer Narrative
Report is incomplete because attempts to obtain product information have been unsuccessful to date.

Event Description
Reporter indicated that vns patient had passed away. It was reported that the patient died from a heart attack. No autopsy was performed. The patient reportedly experienced a >50% reduction in seizures with the vns therapy and was receiving vns therapy at the time of death. There is no evidence at this time that the vns system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=481349


« Last Edit: October 09, 2013, 08:46:35 PM by dennis100 » Logged
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« Reply #5 on: August 05, 2010, 11:16:01 AM »

Model Number 100
Event Type Death Patient Outcome Death;
Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. The death certificate listed the immediate cause of death as cardiac arrest. The pt died in the hospital emergency room. Seizure disorder was listed as other significant conditions contributing to the death but not related. H. 6: device programming history was reviewed. Review of device programming history revealed no anomalies. Device diagnostic testing performed 11 days prior to the pt's death was within normal limits, indicating that the device was functioning properly.

Event Description
In the process of contacting the pt's physician to notify him that the pt's device may be nearing end of service, it was discovered that the pt had passed away. Exact date and cause of death are unknown 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=446009

« Last Edit: October 09, 2013, 08:47:14 PM by dennis100 » Logged
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« Reply #6 on: February 17, 2011, 11:45:33 PM »

Event Date 03/08/2005
Event Type Death Patient Outcome Death;
Event Description
Further follow-up revealed that an autopsy was not performed. The death certificate listed the immediate cause of death as cardiopulmonary arrest.

Event Description
Vns pt had passed away. It was reported that the pt died while hospitalized; however, the reason for hospitalization and the cause of death are not known. No autopsy was performed. The device reportedly explanted and disposed of and the pt was cremated. Treating neurologist indicated that the pt experienced no change in seizure control with the vns therapy and that he was reciving therapy at the time of death. Device diagnostic testing performed at office visit approximatley 2 weeks prior to death was within normal limits, indicating proper device function at that time. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. There is no evidence at this time that the vns therapy system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=593918


« Last Edit: October 09, 2013, 08:48:26 PM by dennis100 » Logged
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« Reply #7 on: July 15, 2011, 01:24:58 AM »

Event Date 07/11/2004
Event Type Death Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away. Certificate of death indicates that the pt died while hospitalized. Immediate cause of death is listed as cardiac arrest. No autopsy was performed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. There is no evidence at this time that the vns therapy system caused or contributed to the reported event.

Manufacturer Narrative
Report is incomplete because no response has been received to mfr's request for add'l info from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=538623
« Last Edit: October 09, 2013, 08:49:46 PM by dennis100 » Logged
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« Reply #8 on: July 15, 2011, 01:26:19 AM »

Event Date 02/01/2002
Event Type Death Patient Outcome Death;
Manufacturer Narrative
Further follow-up revealed that the patient died as a result of cardiac arrest. No autopsy was performed.

Event Description
In the process of coordinating generator replacement surgery prior to end of service, mfr was notified that pt had passed away. The pt's generator was not replaced prior to their death. Device diagnostic testing at last office visit (12/2001) was within normal limits, indicating proper device function at that time. Physician planned to see the pt again in 3/2002 and refer pt to neurosurgeon for generator replacement at that time. Attempts to contact the pt on within 3 days in 02/2002 were unsuccessful and the pt did not keep their appointment with the physician on 03/2002. It was later discovered that the pt had passed away. Exact date and cause of death are unknown at this time. The pt was reportedly receiving vns therapy at the time of death. The physician indicated that the relationship between the cause of death and the ncp system is unknown at this time. It is unknown at the time whether an autopsy was performed. Attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=403612

« Last Edit: October 09, 2013, 08:50:28 PM by dennis100 » Logged
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« Reply #9 on: July 15, 2011, 01:28:19 AM »

Event Date 09/26/2005
Event Type Death Patient Outcome Death;
Event Description
Reporter indicated that vns pt passed away due to cardiac arrest. Autopsy was not performed. Certificate of death lists cardiopulmonary arrest, heart failure, multiple myocardial infarctions as cause of death. The pt died at his residence. The pt experienced a >50% reduction in seizures with the vns therapy and was receiving therapy at the time of death. There is no evidence of this time that the vns therapy system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=645431

« Last Edit: October 09, 2013, 08:50:56 PM by dennis100 » Logged
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« Reply #10 on: July 15, 2011, 01:29:40 AM »

Event Date 09/10/2010
Event Type Death Patient Outcome Death;
Event Description
It was reported by a medical examiner's assistant that a vns patient had passed away with no additional information provided. Follow-up with the medical examiner through a patient death follow-up form revealed the patient died of cod-cardiac dysrhythmia due to epilepsy and the relationship between vns and the cause of death was unknown. Moreover, it was indicated by the medical examiner that the patient's death was not witnessed, and the patient was receiving vns therapy at the time of death. An autopsy was performed on the patient, and the explanted generator and lead were returned to the manufacturer to undergo product analysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1867784

« Last Edit: October 09, 2013, 08:51:26 PM by dennis100 » Logged
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« Reply #11 on: July 15, 2011, 01:30:43 AM »

Event Date 10/08/2005
Event Type Death Patient Outcome Death;
Event Description
Certificate of death lists asystole as the immediate cause of death, due to or as a consequence or respiratory arrest (minutes) due to or as a consequence of cardiac arrest (minutes), due to or as a consequence of seizure disorder. The patient died in the hospital emergency room.

Event Description
Reporter indicated that vns patient had passed away, presumably due to cardiac arrest. The patient was found unresponsive on the kitchen floor. Autopsy was not performed. The pt reportedly benefited from the vns therapy and was receiving therapy at the time of death. Device diagnostic testing performed approximately two months prior to death was within normal limits, indicating proper device function at that time. There is no evidence at this time that the ncp system caused or contributed to the reported event.

Manufacturer Narrative
H. 6: ncp system labeling states that the safety and efficacy of this therapy have not been systematically established for use in patients with history of previous therapeutic brain surgery. Additionally, ncp system labeling cautions that patients with obstructive sleep apnea (osa) may have increased apneic events during stimulation. Cyberonics recommends care when treating patients with preexisting osa. Lowering stimulus frequency or prolonging off time may prevent exacerbation of osa. Medical examiner reportely does not believe that the patient's death was related to epilepsy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=645807

« Last Edit: October 09, 2013, 08:52:31 PM by dennis100 » Logged
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« Reply #12 on: July 15, 2011, 01:31:35 AM »

Event Date 05/10/2003
Event Type Death Patient Outcome Death;
Manufacturer Narrative
H. 6. : device manufacturing records were reviewed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Neurosurgeon indicated that they believed relationship between the vns therapy system and the cause of death was unk.

Event Description
Vns pt had passed away the day after vns implant surgery. The implant surgery occurred without complication. The pt ws receiving vns therapy at the time of death as stimulation was initated in the operating room at the time of implant. No autopsy was performed. Death certificate lists myocardial infarction as cause of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=464817


« Last Edit: October 09, 2013, 08:53:22 PM by dennis100 » Logged
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« Reply #13 on: July 15, 2011, 01:32:48 AM »

Event Date 12/12/2002
Event Type Death Patient Outcome Death;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional info from treating neurologist. H. 6. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Mfr periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Mfr became aware of pt death during this process and evaluated available info against current procedures. The event did not meet mdr reporting criteria per manufacturer's current procedures. In an effort to obtain additional info regarding patient deaths for summary reporting request, certificate of death was requested, received and reviewed by the mfr. Death certificate indicates that pt died while hosptialized. Immediate cause of death is listed as cardiopulmonary arrest. No autopsy was performed. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy cause or contributed to the patient's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=510117

« Last Edit: October 09, 2013, 08:54:24 PM by dennis100 » Logged
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« Reply #14 on: July 15, 2011, 01:33:35 AM »

Event Date 11/09/2002
Event Type Death Patient Outcome Death;
Manufacturer Narrative
H. 6. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Mfr periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Mfr became aware of pt death during this process and evaluated available info against current procedures. The event did not meet mdr reporting criteria per manufacturer's current procedures. In an effort to obtain additional info regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by mfr. Death certificate indicates that pt died at home of cardiac arrest. No autopsy was performed. It was reported that the pt experienced a >25% reduction in seizures with the vns therapy and that the pt was receiving therapy at the time of death. Treating neurologist indicated that the death was not related to the ncp system. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the patient's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=510233

« Last Edit: October 09, 2013, 08:55:14 PM by dennis100 » Logged
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« Reply #15 on: July 15, 2011, 01:39:14 AM »

Event Date 07/14/2004
Event Type Death Patient Outcome Death;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional info from treating neurologist (via fax x1).

Event Description
Reporter indicated that the pt went to the emergency room after experiencing cardiac arrest, and subsequently died. The death certificate listed the immediate cause of death as cardiac arrhythmia, due to (or as a consequence of) hypoxia, due to (or as a consequence of) recurrent seizures. The manner of death was listed as natural. An autopsy was not performed. Further follow-up revealed that the pt's family memberr did not want the device explanted prior to burial. There is no evidence that the vns therapy system caused or contributed to the pt's death. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=538982

« Last Edit: October 09, 2013, 08:55:56 PM by dennis100 » Logged
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« Reply #16 on: July 15, 2011, 01:39:44 AM »

Event Date 07/02/2004
Event Type Death Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away. It was reported that prior to death, the pt had a brief convulsion at the group home where they reside and that they were recovering from it. It was reported that the pt was left alone by the group home members and when they returned pt was found dead. Neurologist indicated that the pt had cardiopulmonary arrest and could not be resuscitated. The pt was receiving vns therapy at the time of death. Neurologist indicated that the cause of death was not related to the ncp system. No autopsy was performed. There is no evidence at this time that the vns therapy system caused or contributed to the reported event. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=537870


« Last Edit: October 09, 2013, 08:56:36 PM by dennis100 » Logged
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« Reply #17 on: July 15, 2011, 01:40:23 AM »

Event Date 05/12/2000
Event Type Death Patient Outcome Death;
Manufacturer Narrative
Report is incomplete because no response as been received to manufacturer's request for additional information form treating neurologist. H. 6. Review of manufacturing records for both pulse generator and bipolar lead revealed no anomalies that would adversely effect device performance. Review of device programming history revealed that device diagnostic testing approximately 3 weeks prior to death was within normal limits, indicating proper device function at that time.

Event Description
Manufacturer periodically compares device tracking information to the social security death index for the purpose of updating device tracking data. Manufacturer became aware of pt death during this process and evaluated available information against current procedures. The event did not meet mdr reporting criteria per manufacturer's current procedure. In an effort to obtain additional information regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by manfacturer. Death certificate indicates that pt died while hospitalized. Immediate cause of death is listed as grand mal seizure, due to or as a consequence of cardio-respiratory arrest. No autopsy was performed. There is no evidence that the ncp system caused or contributed to the reported event; however, on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=514437

« Last Edit: October 09, 2013, 08:57:38 PM by dennis100 » Logged
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« Reply #18 on: July 15, 2011, 01:42:22 AM »

Event Date 02/11/2005
Event Type Death Patient Outcome Death;
Manufacturer Narrative
H. 6. Vns therapy system labeling states that the safety and efficacy of this therapy have not been systematically established for use in pts with history of previous therapeutic brain surgery. H. 6. Treating neurologist indicated that the event was not related to the vns therapy system.

Event Description
Reporter indicated tht vns pt had passed away. The pt reportedly died while home alone and was found face down on bed. Death certificate lists cardioplumonary arrest, due to or as a consequence of mental retractation, due to or as a consequence of epilepsy as the cause of death. It was reported that the pt experienced a >25% reduction in seizures with the vns therapy and that pt was receiving therapy at the time of death. No autopsy was performed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. There is no evidence at this time that the vns therapy system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=581134

« Last Edit: October 09, 2013, 08:58:19 PM by dennis100 » Logged
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« Reply #19 on: July 15, 2011, 01:43:19 AM »

Event Date 05/24/2000
Event Type Death Patient Outcome Death;
Manufacturer Narrative
Report is incomplete because no response has been rec'd to mfr's request for add'l info from treating neurologist. H. 6. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Review of device programming history revealed that device diagnostic testing on day of implant was within normal limits, indicating proper device function at that time.

Event Description
Mfr periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Mfr became aware of pt death during this process and evaluated available info against current procedures. The event did not meet mdr reporting criteria per mfr's current procedures. In an effort to obtain add'l info regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by mfr. Death certificate indicates that pt died in hosp e. R. Immediate cause of death is listed as pulseless electrical activity (for minutes duration), due to or as a consequence of severe seizure disorder (for years duration). No autopsy was performed. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=513687


« Last Edit: October 09, 2013, 08:59:09 PM by dennis100 » Logged
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« Reply #20 on: July 15, 2011, 01:43:55 AM »

Event Date 09/26/2007
Event Type Death Patient Outcome Death;
Manufacturer Narrative
Clin auton res (2007), exacerbation of electrical storm subsequent to implantation of a right vagal stimulator. Doi 10. 1007/s10286-007-0440-1. Shalaby, a, et al.

Event Description
Reporter indicated a pt's death was possibly due to exacerbation of a lethal ventricular arrhythmia by vns therapy and severe underlying cardiac disease. The pt was implanted on the right vagus nerve. The pt was buried with the vns and no autopsy was performed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1006210
« Last Edit: October 09, 2013, 08:59:58 PM by dennis100 » Logged
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« Reply #21 on: July 15, 2011, 01:44:49 AM »

Event Date 01/06/2005
Event Type Death Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away. It was reported that the pt had several seizures, aspirated and then had a heart attack. No autopsy was performed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. There is no evidence at this time that the vns therapy system caused or contributed to the reported event.

Manufacturer Narrative
Certificate of death has been requested, but not yet received. H. 6: treating neurologist indicated that the vns therapy system was not related to the cause of death.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=571493


« Last Edit: October 09, 2013, 11:28:57 PM by dennis100 » Logged
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« Reply #22 on: July 15, 2011, 01:45:38 AM »

Event Date 08/28/2009
Event Type Death Patient Outcome Death;
Event Description
It was initially reported that the patient died due to unknown reasons, but it is believed by the neurologist's office that the death was unrelated to vns, although the cause was unknown. The patient was said to have had surgery that was unrelated to vns therapy the day prior to his death. The patient was last seen in 2009, and was scheduled to be seen four months later. Two months prior to scheduled date, between 6 and 6:30, reporting that the patient had pulled his iv out and that the staff were not able to reestablish peripheral iv access. The nurse reported that the tube feedings were well tolerated overnight and that there was about 150mls of drainage from the gastrostomy, which was considered appropriate. The nurse reported that he was evidently having some pain and a single dose of morphine 8mg subcutaneous was ordered. About an hour later, it was reported that the patient had suffered a cardiac arrest and expired. Apparently, it started with a seizure according to the witnesses and became a cardiac arrest, and resuscitation efforts were unsuccessful including involvement from a physician in the emergency room. No autopsy was performed on the patient. The device was returned to the manufacturer for analysis, but has yet to be performed. 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=1488684

« Last Edit: October 09, 2013, 11:30:43 PM by dennis100 » Logged
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« Reply #23 on: July 15, 2011, 01:46:37 AM »

Event Date 12/23/2002
Event Type Death Patient Outcome Death;
Manufacturer Narrative
H. 6. Ncp system labeling states that the safety and efficacy of this therapy have not been systematically established for use in pts with history of previous therapeutic brain surgery. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Mfr periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Mfr became aware of pt death during this process and evaluated available info against current procedures. The event did not meet mdr reporting criteria per mfr's current procedures. In an effort to obtain additional info regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by mfr. Death certificate indicates that pt died while hospitalized. Immediate cause of death is listed as cardiopulmonary arrest (5 minutes duration), due to grand mal seizure (10 minutes duration), due to epilepsy (20 years duration). No autopsy was performed. The pt had undergone generator replacement surgery approximately 2 weeks prior to death. It was reported that the pt experienced no change in seizure control with the vns therapy. It was reported that the pt initially responded to the vns therapy, but then relapsed. The pt was receiving therapy at the time of death and was last seen by treating neurologist 6 days prior to death. Neurologist indicated that pt's death was not related to the ncp system. There is no evidence that the ncp system caused or contributed to the reported event however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=513699


« Last Edit: October 09, 2013, 11:32:10 PM by dennis100 » Logged
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« Reply #24 on: July 15, 2011, 01:47:38 AM »

Event Date 04/18/2002
Event Type Death Patient Outcome Death;
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's request for additional info from treating neurologist. H. 6. Device manufacturing records were reviewed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Mfr periodically compares device tracking info to the social security death index for the purpose of updating device tracking data. Mfr became aware of pt death during this process and evaluated available info against current procedures. The event did not meet mdr reporting criteria per manufacturer's current procedures. In an effort to obtain additional info regarding pt deaths for summary reporting request, certificate of death was requested, received and reviewed by mfr. Death certificate indicates that the immediate cause of death was cardiopulmonary failure due to (or as a consequence of) seizure activity. No autopsy was performed. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=512475
« Last Edit: October 09, 2013, 11:33:06 PM by dennis100 » Logged
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« Reply #25 on: July 15, 2011, 01:49:55 AM »

Event Date 11/26/2003
Event Type Death Patient Outcome Death;
Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist. Certificate of death has been requested but not yet received. The device was not explanted prior to burial. H. 6. : review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. H. 6. : the vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. In the united states, the vns therapy system is approved for use in adults and adolescents with partial onset seizures that are refractory to antiepileptic medications.

Event Description
Reporter indicated that vns pt had passed away. It was reported that the pt had been sick prior to death. Treating physician reportedly indicated that the death may have been due to stroke since the pt's eye was blood shot and that the death was cardiac related. No autopsy was performed. The pt did receive efficacy from the vns therapy. 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=503036

« Last Edit: October 09, 2013, 11:33:42 PM by dennis100 » Logged
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« Reply #26 on: July 15, 2011, 01:50:36 AM »

Event Date 05/08/2003
Event Type Death Patient Outcome Death;
Manufacturer Narrative
H. 6. Device mfg records were reviewed. H. 6. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Mfr became aware of pt death and evaluated available info against current procedures. In an effort to obtain add'l info, certificate of death was requested, received and reviewed by mfr. Death certificate indicates that the pt died while hospitalized. Immediate cause of death is listed as hypoxia secondary to cardiac arrest. No autopsy was performed. It was reported that the pt averaged 50 seconary generalized seizures per month and experienced no change in seizure control with the vns therapy. Treating neurologist indicated that the ncp system was not related to the cause of death. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=501697

« Last Edit: October 09, 2013, 11:34:19 PM by dennis100 » Logged
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« Reply #27 on: July 15, 2011, 01:51:15 AM »

Event Date 03/28/2003
Event Type Death Patient Outcome Death;
Event Description
Mfr became aware of pt death and evaluated available info against current procedures. In an effort to obtain add'l info, certificate of death was requested, received and reviewed by mfr. Death certificate indicates that the pt died in hosp emergency room. Cause of death is listed as cardio pulmonary arrest. No autopsy was performed. It was reported that the pt had experienced a >50% reduction in seizures with the vns therapy and had been seizure-free for two months prior to death. The pt was receiving therapy at the time of death. Treating neurologist indicated that the vns therapy system was not related to the cause of death. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pt's death, it cannot be definitively ruled out as a factor.

Manufacturer Narrative
H. 6. Device mfg records were reviewed. H. 6. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=501718

« Last Edit: October 09, 2013, 11:37:04 PM by dennis100 » Logged
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« Reply #28 on: July 15, 2011, 01:52:13 AM »

Event Date 09/22/2003
Event Type Death Patient Outcome Death;
Manufacturer Narrative
Device manufacturer contacted pt's family member nine months prior to date of death to notify him that the pt's device may be nearing end of service. The pt's family member indicated at that time that the pt had never really benefited from the vns therapy. The pt's family member indicated that the device had reached end of service approximately one year before and was not explanted. H. 6. : device programming history was reviewed. Device manufacturing records were reviewed. H. 6. : review of device programming history did not reveal any anomalies but was inconclusive in determining whether device was functioning properly at time of death due to limited amount of available data for review. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Vns pt passed away. Death certificate indicates that pt died in hospital emergency room. Immediate cause of death is listed as cardiopulmonary arrest. No autopsy was performed. 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=499276



« Last Edit: October 09, 2013, 11:38:50 PM by dennis100 » Logged
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« Reply #29 on: July 15, 2011, 01:53:09 AM »

Event Date 04/08/2005
Event Type Death Patient Outcome Death;
Event Description
Further follow-up revealed that an autopsy was not performed. The death certificate listed the immediate cause of death as acute respiratroy failure, acute myocardial infarction, urosepsis. Other significant conditions were listed as hypothyroidism, quadriplegia, seizure disorders, cerebral palsy, history or meningitis.

Event Description
Vns pt passed away due to heart attack. Neurologist indicated that the pt experienced a >50% reduction in seizures with vns therapy. The pt was receiving vns therapy at the time of death. Neurologist indicated that the relationship between the ncp system and the cause of death was unknown. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. There is no evidence at this time that the vns therapy system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=602194


« Last Edit: October 09, 2013, 11:39:48 PM by dennis100 » Logged
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