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Deadly VNS
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dennisfegan posted:
On July 2 2006 I had what I thought was a bad run of atonic seizures. My parents happened to stop by that Sunday morning and realized something was terribly wrong with me. They called my neuro and EMS.

My last memory of that morning was being inside of the ambulance the next thing I remember was being in the ICU.

The VNS was stopping my heart (asystole) during the 30 second stimulation cycles. If my parents hadn't stopped by that day I would have died and my death would have probably been written off as status or SUDEP.

My story was told in Reader's Digest - "Medical Devices That Can Kill" and the British Medical Journal - "Why the FDA can't Protect the Public"

Reader's Digest
http://newamerica.net/publications/articles/2010/medical_devices_th...


The British Medical Journal
http://newamerica.net/publications/article/2011/why_the_fda_can_t_...


A couple of examples taken from the FDA's adverse databank


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
2 Replies |Watch This Discussion | Report This| Share this:Deadly VNSOn July 2 2006 I had what I thought was a bad run of atonic seizures. My parents happened to stop by that Sunday morning and realized something was terribly wrong with me. They called my neuro and EMS.<br /><br />My last memory of that morning was being inside of the ambulance the next thing I remember was being in the ICU.<br /><br />The VNS was stopping my heart (asystole) during the 30 second stimulation cycles. If my parents hadn't stopped by that day I would have died and my death would have probably been written off as status or SUDEP.<br /><br />My story was told in Reader's Digest - "Medical Devices That Can Kill" and the British Medical Journal - "Why the FDA can't Protect the Public"<br /><br />Reader's Digest<br /><a href="http://newamerica.net/publications/articles/2010/medical_devices_th">http://newamerica.net/publications/articles/2010/medical_devices_th</a>...<br /><br /><br />The British Medical Journal<br /><a href="http://newamerica.net/publications/article/2011/why_the_fda_can_t_">http://newamerica.net/publications/article/2011/why_the_fda_can_t_</a>...<br /><br /><br />A couple of examples taken from the FDA's adverse databank<br /><br /><br />Event Date 01/01/2006<br />Event Type Injury Patient Outcome Required Intervention <br />Event Description <br />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.<br /> <br /><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=675911">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=675911</a> <br /><br />Event Date 03/03/2008<br />Event Type Injury Patient Outcome Required Intervention <br />Event Description <br />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.<br /> <br /><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1022608">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1022608</a>
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dennisfegan responded:
Some more reports

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


Event Date 01/01/2007
Event Type Injury Patient Outcome Required Intervention; Hospitalization Life Threatening
Event Description
Reporter indicated that the pt was admitted to the hosp for pulmonary problems following a vns replacement. Follow-up with physicians indicated that the pt experienced bradycardia, hypotension, and respiratory failure which required cardiac life support and hospitalization. X-rays reviewed by mfr did not reveal any anomalies. The pt experienced four more instances of bradycardia, hypotension, and a decrease in breathing rate which initially required temporary disablement of the vns with a magnet and finally resulted in programming the device off. It was reported that the pt was hospitalized for all four of these events. The pt's events have resolved since the vns has been turned off. The physicians indicated that "almost with 100% certainty that this is related to vns" and that the device will not be explanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=842295
Report This| Share this:Deadly VNSSome more reports<br /><br />Event Date 01/10/2006<br />Event Type Injury Patient Outcome Required Intervention <br />Event Description <br />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.<br /> <br /><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=689307">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=689307</a> <br /><br /><br />Event Date 01/01/2007<br />Event Type Injury Patient Outcome Required Intervention; Hospitalization Life Threatening <br />Event Description <br />Reporter indicated that the pt was admitted to the hosp for pulmonary problems following a vns replacement. Follow-up with physicians indicated that the pt experienced bradycardia, hypotension, and respiratory failure which required cardiac life support and hospitalization. X-rays reviewed by mfr did not reveal any anomalies. The pt experienced four more instances of bradycardia, hypotension, and a decrease in breathing rate which initially required temporary disablement of the vns with a magnet and finally resulted in programming the device off. It was reported that the pt was hospitalized for all four of these events. The pt's events have resolved since the vns has been turned off. The physicians indicated that "almost with 100% certainty that this is related to vns" and that the device will not be explanted.<br /> <br /><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=842295">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=842295</a>
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avatar
dennisfegan responded:
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


Event Date 01/01/2007
Event Type Injury Patient Outcome Required Intervention; Hospitalization Life Threatening
Event Description
Reporter indicated that the pt was admitted to the hosp for pulmonary problems following a vns replacement. Follow-up with physicians indicated that the pt experienced bradycardia, hypotension, and respiratory failure which required cardiac life support and hospitalization. X-rays reviewed by mfr did not reveal any anomalies. The pt experienced four more instances of bradycardia, hypotension, and a decrease in breathing rate which initially required temporary disablement of the vns with a magnet and finally resulted in programming the device off. It was reported that the pt was hospitalized for all four of these events. The pt's events have resolved since the vns has been turned off. The physicians indicated that "almost with 100% certainty that this is related to vns" and that the device will not be explanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=842295

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

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 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
Report This| Share this:Deadly VNSEvent Date 01/10/2006<br />Event Type Injury Patient Outcome Required Intervention <br />Event Description <br />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.<br /> <br /><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=689307">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=689307</a> <br /><br /><br />Event Date 01/01/2007<br />Event Type Injury Patient Outcome Required Intervention; Hospitalization Life Threatening <br />Event Description <br />Reporter indicated that the pt was admitted to the hosp for pulmonary problems following a vns replacement. Follow-up with physicians indicated that the pt experienced bradycardia, hypotension, and respiratory failure which required cardiac life support and hospitalization. X-rays reviewed by mfr did not reveal any anomalies. The pt experienced four more instances of bradycardia, hypotension, and a decrease in breathing rate which initially required temporary disablement of the vns with a magnet and finally resulted in programming the device off. It was reported that the pt was hospitalized for all four of these events. The pt's events have resolved since the vns has been turned off. The physicians indicated that "almost with 100% certainty that this is related to vns" and that the device will not be explanted.<br /> <br /><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=842295">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=842295</a> <br /><br />Model Number 100<br />Event Type Injury Patient Outcome Life Threatening; Hospitalization<br />Event Description<br />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.<br /><br /><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=245555">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=245555</a><br /><br />Model Number 101<br />Event Date 05/02/2005<br />Event Type Injury Patient Outcome Life Threatening; <br />Event Description <br />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.<br /> <br /><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=613869">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=613869</a><br /><br />Event Date 03/25/2004<br />Event Type Death Patient Outcome Death;<br />Event Description<br />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.<br /><br /><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522043">http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522043</a>
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