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Author Topic: Cardiac Arrest (Asystole)  (Read 20420 times)
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dennis100
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« on: June 14, 2010, 05:52:01 AM »

Epilepsia. 2009 Apr;50(4):928-32. doi: 10.1111/j.1528-1167.2008.01918.x. Epub 2008 Dec 4.
Late-onset periodic asystolia during vagus nerve stimulation.
Iriarte J1, Urrestarazu E, Alegre M, Macías A, Gómez A, Amaro P, Artieda J, Viteri C.
Author information
Abstract
Cardiac changes may occasionally occur during vagus nerve stimulation (VNS) used in epileptic patients. As they can be potentially life-threatening, it is important to detect them, and this is why an intraoperative test is performed during the implantation. Few cases of asystole during this test have been described. Only one patient with late-onset bradyarrythmia caused by VNS has been reported. This patient had been implanted 2 years and 4 months before the episode. We present another case of late asystole in a patient whose VNS had been implanted 9 years before the arrhythmia onset. In our patient, each run of stimulation produced bradyarrhythmias and very often severe asystolia due to atrium-ventricular block.

http://www.ncbi.nlm.nih.gov/pubmed/19055490

________________________________________________________________________________


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

« Last Edit: May 14, 2014, 02:03:25 PM by dennis100 » Logged
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« Reply #1 on: June 14, 2010, 05:53:09 AM »

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


« Last Edit: July 27, 2013, 04:10:58 AM by dennis100 » Logged
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« Reply #2 on: June 14, 2010, 05:54:29 AM »

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
  

« Last Edit: July 27, 2013, 04:12:23 AM by dennis100 » Logged
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« Reply #3 on: June 14, 2010, 05:55:33 AM »

Event Date 05/01/2006
Event Type  Injury   Patient Outcome  Required Intervention  
Event Description  
Reporter indicated that pt began to experience episodes of syncope and asystole approximately six years post vns implant. The pt reported feeling the need to cough, after which he reportedly lost consciousness. Approximately two months after, the onset of symptoms, the pt was hospitalized for eval of the syncope episodes, at which time and ekg revealed episodes of asystole that coincided with device stimulation cycles; however, not every stimulation cycle would produce this event. The vns therapy system was then programmed to off, after which a repeat ekg was normal. The pt did not experience any further episodes of syncope or asystole in the absence of the vns therapy. Eval by cardiologist did not reveal any abnormalities with the pt's heart. The device remains programmed to off. Both the cardiologist and the neurologist believe that the reported events were caused by the stimulation of the vagus nerve. There had been no recent changes to programmed device settings; however, inderal had recently been added to the pt's medication regimen for treatment of mild hypertension.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1629932


« Last Edit: July 27, 2013, 04:13:40 AM by dennis100 » Logged
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« Reply #4 on: June 14, 2010, 05:56:50 AM »

Event Date 12/04/2008
Event Type  Injury   Patient Outcome  Life Threatening; Required Intervention  
Event Description  
It was reported in a scientific article that a vns patient, who had been receiving vns therapy for nine years without complaint, was admitted to the hospital for the control of an episode status epilepticus, an event not uncommon for the patient, for which medication was administered. The patient experienced an increase in seizures during the hospital stay and eeg monitoring revealed the occurrence of periodic cardiac changes with bradyarrhythmia and often severe asystolia due to atrium ventricular block, which coincided with stimulation. The patient was admitted to the cardiac intensive care unit and underwent holter monitorization, because the periodicity of the bradyarrhythmias was the same as that of the ncp stimulation (around 30 s every 5. 5 min), the ncp was stopped. Once the device was disabled, the reported arrhythmia event resolved. The reporter states that though there appears to be a clear relationship to vns therapy, other contributing factors were believed to be present. These factors include the addition of levetiracetam, which had a notable arrhythmic effect on the patient. The author also suggests that the patient's status episode may have predisposed the patient to the vns-related cardiac arrhythmia.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1276878
« Last Edit: July 27, 2013, 04:14:50 AM by dennis100 » Logged
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« Reply #5 on: June 14, 2010, 05:58:01 AM »

Event Date 04/01/2009
Event Type  Injury   Patient Outcome  Hospitalization; Life Threatening Required Intervention  
Event Description  
It was reported that the pt was experiencing an increase in seizures above pre-vns baseline. During these seizures, the pt was having episodes of asystole. Pt was hospitalized and implanted with a pacemaker as a result. Per the treating medical professional, it is unk if the increase in seizures and asystole are related to vns or stimulation. Device diagnostics are all within normal limits. A battery life calculation was run and shows there to be approximately 1. 61 years remaining until end of service. The pt's medication levels were measured and were at zero which indicates the pt has not been compliant with her medication. It is unk at this time if this had an effect on the seizures and/or asystole. Pt will be monitored and no further interventions are planned at this time. All attempts for additional info have been unsuccessful to date.  
  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1373576




« Last Edit: July 27, 2013, 04:15:25 AM by dennis100 » Logged
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« Reply #6 on: June 14, 2010, 05:59:06 AM »

Event Date 09/07/2007
Event Type  Malfunction   Patient Outcome  Other  
Event Description  
The reporter indicated the pt was admitted to cardiac care unit for monitoring. The pt experienced an asystole and bradycardia, approx five or six mos ago. The pt was seen for video monitoring for his seizures. During the monitoring, the reporter noted that "the pt would go into "true persistent asystole with no pulse. " in addition, the pt had an asystole only during a magnet swipe which was set for 60 seconds on. The reporter stated the pt's magnet output current was set to 3. 5 ma. The reporter indicated the normal stimulation was set to 1. 5 ma. The reporter stated "the pt was having a seizure and they swiped the device initiating a magnet mode stimulation. " the reporter noted the asystole was longer, than when they swiped the pt without a seizure. The reporter stated "the asystole and bradycardia are directly related to vns stimulation. " during the pt's admission in the ccu, the reporter lowered the magnet output current to see how the pt would respond to the new settings. The reporter stated the pt was set to 2. 25ma. Thus, the pt no longer had asystole, but bradycardia. The reporter states "this setting does not help the pt's seizures to abort, but the cardiologist was fine with the bradycardia. " the reporter stated "the pt is fine now, just not getting as good of seizure control with the new setting. " good faith attempts to obtain additional info are in progress and awaiting results.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1009251

« Last Edit: July 27, 2013, 04:16:33 AM by dennis100 » Logged
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« Reply #7 on: June 14, 2010, 06:00:19 AM »

Model Number 102
Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Further follow-up (discharge summay dated 2004) revealed that the pt originally received the vns system so that he coul reduce the medications he was taking. The vns did not appear to help, and the pt reportedly began to have recurring and more-frequent events. The pt reported that 80% of the seizures are without warming and 20% are preceded by the sensation of jejavu. The pt feels "generally not right" and has difficulty breathing. He will suddenly stop what he is doing and become pale. His lips will turn blue and he will fall from standing. He denies any convusions. The episodes last 20-30 seconds, sometimes accompanied by brief myoclonus and followed by postictal confusion of 1-20 minutes. There is frequent urinay incontinence but rarely bowel incontinence. The pt was admitted to the impatient monitoring svc to better identify and classify his events for the initial evaluatio of possible surgical intervention. The pt was placed on continuous video-eeg monitoring. He had normal waking background alpha frequency of 11 hz with normal drowsiness and sleep stages identified. The pt had normal, if any, identifable interictal epileptiform discharges. He had several clinical events recorded. The pt had an event where he went from his prior sinus heart rate to a progressive bradycardia,culminating in a 15-second pause that was followed by generalized flattering of the eeg background, followed by some generalized delta events. After this event a cardiology consult was obtained. This was the event that prompted the initial medwatch report. There was concern that the vns system may have contributed to the event, therefore, the vns device was deactivated. Because the pt had the vns device for quite sometime before the asystole event, it was felt by the epilepsy svc to be exceedingly unlikely that the vns device contributed to the episode of asystole. Following the initial event, the pt had several more events, though none were accompanied by significant asystole. It was reported that the episode of asystole may have been triggered by a subtle seizure activity involving the frontal lobe, and there was no way to guarantee that this would not recur. The vns device was not turned back on at this point and it is unk if the vns device is presently activated.

Manufacturer Narrative
Report is incomplete because no response has been received to manufacturer's request for additional information from treating neurologist. H. 6. Vns therapy system labeling lists heart rate/rhythm changes as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns patient was experiencing episodes of asystole. The cause of the episodes is unknown. The patient was subsequently implanted with a pacemaker. The patient's vns therapy system was programmed to off prior to the pacemaker implant surgery and was programmed to on at certain points during the pacemaker implant surgery to assess whether the vns therapy affected the pacemaker sensing capabilities. When the pacemaker leads were implanted and connected to monitoring equipment, the vns therapy system was programmed to on at 1. 0ma output current. There were no changes to the monitoring equipment while the device was programmed to on at 1. 0ma output current. Normal mode output current was then increased from 1. 0ma to 2. 0ma with no changes to the monitoring equipment. Due to patient discomfort, the vns therapy system was programmed back to 0ma after approximately 10 seconds. The pacemaker battery was then implanted and connected to the pacemaker leads. The vns therapy system was then programmed to on at 3. 5ma normal mode output current in order to test the vns generator with the pacemaker and the pacemaker's monitoring equipment. After approximately 10 seconds, the vns therapy system was programmed back to off. Upon completion of the pacemaker implant surgery, the vns therapy system was interrogated to confirm that the device was programmed to off (0ma output current). Investigation to date has been unable to determine whether a relationship exists between the episodes of asystole and the vns therapy system. The patient's neurologist indicated that he was not aware of the patient having cardiac problems prior to the vns implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=566648


« Last Edit: July 27, 2013, 04:19:05 AM by dennis100 » Logged
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« Reply #8 on: June 14, 2010, 06:01:46 AM »

Event Date 10/01/2008
Event Type  Injury   Patient Outcome  Life Threatening; Required Intervention  
Event Description  
It was reported that a vns pt was admitted to the hosp due to a massive increase in seizures. Several medications were administered to the pt in order to address the seizure activity which only had transient effects. The pt was transferred to an intensive care unit for the application of thiopental. The reporter indicated that prior to administering the thiopental for status epilepticus and mechanical ventilation, a cardiac arrhythmia was observed. The reporter stated that a complete heart block was recorded on ecg in addition to event of asystole lasting approx six seconds with a spontaneous recovery. The pt's vns device was programmed off and add'l arrhythmia events reportedly recorded. The reporter indicated that vns therapy settings had remained unchanged prior to the event and that at this time they have been unable to tell whether there was an exact time correlation between the pt's arrhythmia and device stimulation. The reporter also indicated that the pt's device would remain disabled until they were "100% sure, that there is no logical connection possible between the vns-stimulation and that event. " the cause of the arrhythmia event and its relationship to vns therapy is unk. Good faith attempts for add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1281061



« Last Edit: July 27, 2013, 04:20:48 AM by dennis100 » Logged
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« Reply #9 on: June 14, 2010, 06:02:59 AM »

Event Date 04/01/2009
Patient Outcome  Other;  
Event Description  
Pt had cluster of 7 seizures over 2 days, resulting in emergency room visit and hospitalization on epilepsy monitoring unit. A few days prior to this, patient had a suspected seizure that was different in appearance than prior events. Medication changes were made. During the hospitalization, patient was placed on eeg telemetry where two seizures were recorded with a period of asystole lasting 18 seconds during the seizure. The patient did not have a prior history of bradycardia or cardiac difficulties. Since patient had an implanted vagus nerve stimulator, this was interrogated and tested to ensure that the device was working properly. Testing the device was not associated with change in heart rate. Epilepsy team believes that the seizure was associated with asystole and not the vagus nerve stimulator, but since asystole had been reported in a few instances of new implants with vns, the vns device was watched carefully in this patient. A cardiac pacemaker was implanted and the vns was tested during this procedure. The vns was not found to interfere or affect the cardiac pacemaker. The vns is gradually being reprogrammed to the patient's usual settings as a treatment for her seizures. Patient's medications were adjusted during the hospitalization, and she was discharged twelve days later in 2009. Pt seen in clinic today for follow-up of vns and no further problems have been noted. Diagnosis or reason for use: intractable epilepsy.  
 

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1365329
« Last Edit: July 27, 2013, 04:22:11 AM by dennis100 » Logged
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« Reply #10 on: June 14, 2010, 06:04:17 AM »

Event Date 04/01/2005
Event Type  Injury   Patient Outcome  Required Intervention  
Event Description  
Reporter indicated that vns pt experienced a brief episode of asystole along with episodes of bradycardia. The pt reportedly does not remember their actions following their seizures and recently wandered into a dog pen containing pit bulls while in their post-ictal state. The pt was attacked by the dogs and was subsequently hospitalized in intensive care. While hospitalized, the episodes of bradycardia and one ten-second episode of asystole were noted. Treating cardiolgoist believes that the bradycardia and asystole may have been caused by the vns therapy. Stimulation was temporarily discontinued by placing the magnet over the device, after which no further episodes of bradycardia or asystole were noted. The magnet was removed from the device and stimulation was resumed. It is not known whether any further incidents of bradycardia or asystole occurred when stimulation was resumed. Review of manufacturing records for both the pulse generator and the bioplar lead revealed no anomalies that would adversely affect device performance. Investigation to date has been unable to confirm the cause of the reported events.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=601873

« Last Edit: July 27, 2013, 04:23:34 AM by dennis100 » Logged
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« Reply #11 on: June 14, 2010, 06:05:31 AM »

Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Hospitalization; Required Intervention  
Event Description  
Reporter indicated that the pt entered the hosp after suffering with what was described as a "code blue," subsequently the pt "experienced three more cardiac arrests and/or respiratory arrests. " the reporter indicated that the pt was in the hosp for two weeks and discharged last week. The reporter did not explant the device and opt-ed to turn the device off. Since, the reporter wants to find the cause of the arrest. The pt was referred to a cardiologist for eval. Good faith attempts are in progress to obtain additional info.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=992765


« Last Edit: July 27, 2013, 04:25:05 AM by dennis100 » Logged
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« Reply #12 on: June 14, 2010, 06:06:44 AM »

Event Type  Injury   Patient Outcome  Life Threatening;  
Event Description  
Further follow-up revelaed that the device remains programmed off. It was reported that the reported events have not recurred. It is unknown if the reported events are related to vns therapy due to lack of information from treating physician.  
  
Event Description  
Further follow-up revealed that the vns system is still turned off and the pt has not experienced further assystole. The physician reported the vns therapy is possibly related to the event. The physician also reported that the pt does not have any cardiac history that might have contributed to the event. The plan is to keep the vns system turned off. The device was reportedly not on the time of the reported event (dysphagia, dyspnea and asysteole), therefore, it is not likely that the vns contributed to the event.  
  
Event Description  
While undergoing an ekg, the pt developed dyshagia and dyspnea and their heart stopped. Cardiopulmonary resuscitation was not required. It was reported that the pt's device was programmed to off at the time of the event. Report is incomplete because no response has been received to mfr's request for additional info from treating physician (via fax x1).  
  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=616495
« Last Edit: July 27, 2013, 04:26:09 AM by dennis100 » Logged
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« Reply #13 on: June 14, 2010, 06:07:55 AM »

Event Date 03/13/2010
Event Type  Injury   Patient Outcome  Required Intervention;  
Event Description  
It was initially reported that a pt was having episodes of bradycardia with a heart rate in the 30s and was also experiencing a few episodes of asystole (each about 5 seconds in duration). The cardiologist thought it may possibly be related to the pt's vns device. A company rep went to the pt's next appt and was unable to interrogate the pt's device due to believed end of service. A battery life calculation was performed using the pt's programming history available in the in-house database (current from date of implant to (b) (6) 2009) and it was found that the device may be at end of service. Good faith attempts to obtain add'l info have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1658341
 
« Last Edit: July 27, 2013, 04:26:58 AM by dennis100 » Logged
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« Reply #14 on: June 30, 2010, 04:27:42 AM »

Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Other;  
Event Description  
Reporter indicated a vns pt, while in the icu unit, experienced asystole that lasted for approx 4 seconds followed by a 2 to 1 heart block that lasted about 12 seconds. The pt has not experienced any other instances of arrhythmia since that occurred. The pt was under sedation when the event occurred. The physician indicated the arrhythmia seemed vagal to him in nature. The physician indicated the stimulation, coupled with the sedation, might have caused the asystole event. He also said he did not plan to change anything with the vns as the pt's seizures are controlled. Diagnostic testing was performed on the vns therapy system, which yielded normal results. Good faith attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=989724
  
« Last Edit: July 27, 2013, 04:27:37 AM by dennis100 » Logged
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« Reply #15 on: June 30, 2010, 11:54:56 AM »

Event Date 04/22/2008
Event Type  Injury   Patient Outcome  Required Intervention; Hospitalization  
Event Description  
Initial reporter indicated that the vns pt was having gradual 10 sec pauses to her heart rate. Heart rate is 30-40 beats per minute. It was thought by the pt's treating neurologist's office that the event could possibly be related to pt stress and being overweight. The pt was implanted with the vns in 2005 and this is new event for the pt. The pt has had no previous cardiac interventions taken. The pt had a pacemaker inserted. All system diagnostic testing was within normal limits after the pacemaker insertion. Good faith attempts have been made for additional info surrounding the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1046053

« Last Edit: July 27, 2013, 04:28:12 AM by dennis100 » Logged
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« Reply #16 on: June 30, 2010, 08:45:28 PM »

Event Date 06/01/2008
Event Type  Injury   Patient Outcome  Hospitalization;  
Event Description  
It was reported that a vns pt was experiencing increase in seizures and heart problems. The pt had been admitted to the hospital due to depacod intoxication from medication. In the hospital, it was observed that the pt had spells of bradycardia believed to be due to vns therapy. The magnet was placed over the generator to turn off vns stimulation. It was then observed that the pt had episodes of sinus arrest lasting 5-6 seconds and occurring frequently. The er physician was unsure if the magnet had actually stopped vns stimulation and requested that a doctor familiar with vns would program the device off to determine if the occurrences of sinus block were related to vns therapy. Good faith attempts to obtain additional info have been unsuccessful to date.  


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1096491

« Last Edit: July 27, 2013, 04:28:38 AM by dennis100 » Logged
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« Reply #17 on: July 09, 2010, 03:17:50 AM »

Event Date 10/24/2001
Event Type  Death   Patient Outcome  Death;  
Event Description  
Reporter indicated that pt was found "with breathing standstill and stopped heart functions, successful reanimation". Device was turned off in 2001. Further follow-up indicated that the pt suffered from pneumonia that was untreatable. Pt was last seen at the physician's office 6 days ago.  

Manufacturer Narrative  
Physician was not willing to provide copy of death certificate. It was reported that the pt had taken all anti-epileptic medications available at one time or another. Pt was implanted on 9/4/01. Pt was found not breathing on the morning of 9/6/01. Pt's device was programmed to off on 9/14/2001. Pt was last seen by phsyician on 10/18/2001. Pt expired on 10/24/2001 due to complications from untreatable pneumonia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=377400
  
« Last Edit: July 27, 2013, 04:29:29 AM by dennis100 » Logged
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« Reply #18 on: July 09, 2010, 05:54:30 AM »

Event Date 05/21/2002
Event Type  Injury   Patient Outcome  Life Threatening; Hospitalization Required Intervention  
Event Description  
Reporter indicated that pt had a 1st degree heart block following chronic vns (pr interval approximately. 35 with periods of asystole of 2-3 seconds). A 24-hour ecg was performed. After programming the vns to off, the ecg immediately improved. Further follow-up revealed that the pt was diagnosed by a cardiologist with 3rd degree heart block and was hospitalized for pacing. It is suspected that the lead coils may be placed too near to the carotid branch. It was later reported that the pt still has a long pr interval and some asystole, but much less. The physician's opinion, the vns device was exacerbating an underlying cardiac problem that was not previously detected. Physician plans to admit pt for overnight monitoring to determine if the pt has epilepsy at all.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=401064
« Last Edit: July 27, 2013, 04:30:03 AM by dennis100 » Logged
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« Reply #19 on: July 12, 2010, 12:50:09 AM »

Event Date 05/01/2004
Event Type  Injury   Patient Outcome  Life Threatening; Hospitalization Death  
Event Description  
Reporter indicated that vns pt was hospitalized in icu for heart arrest. The pt reportedly had a seizure and went into cardiopulmonary arrest. At some point during hospitalization, the pt aspirated and subsequently experienced elevated white blood cell count that led to viral infection. The pt continues to have frequent seizures. Treating neurologist indicated that he was not sure whether the pt's medical issues were related to the vns and that he was considering temporarily discontinuing stimulation to see if the pt's condition improved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=525928
« Last Edit: July 27, 2013, 04:30:56 AM by dennis100 » Logged
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« Reply #20 on: July 14, 2010, 10:31:38 AM »

Event Date 01/11/2008
Event Type  Injury   Patient Outcome  Life Threatening;  
Event Description  
Reporter indicated that a vns patient was experiencing 30 second periods of heart block associated with stimulation on times and subsequent arrhythmias. The patient has a prior history of syncope and heart rate irregularities. Diagnostic testing showed the device to be functioning properly. Ekg strips were evaluated and showed that the patient was experiencing a ventricular standstill. The device was programmed off.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=992788



« Last Edit: July 27, 2013, 04:32:07 AM by dennis100 » Logged
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« Reply #21 on: July 16, 2010, 10:35:20 PM »

Event Date 07/02/2006
Event Type  Injury   Patient Outcome  Life Threatening; Hospitalization  
Event Description  
Asystole related to malfunction of vagal nerve stimulator. Occurred at least 8 times.  
  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=795000


« Last Edit: July 27, 2013, 04:32:30 AM by dennis100 » Logged
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« Reply #22 on: July 25, 2010, 12:33:31 PM »

Event Date 10/10/1998
Event Type  Death   Patient Outcome  Death;  
Manufacturer Narrative  
Field report: death reported. Pt death follow-up form: physician reports believed relationship between the ncp system and cause of death to be unknown. In 10/1998, asystolic, but "not cyanotic. " at that point the impression was anoxic encephalopathy following cardio-respiratory arrest most likely secondary to a seizure. Next day, pt's parent stated that they thought the pt suffocated by turning face into pillow while having a complex partial seizure rather than developing arrythmia and arrest during the seizure. Communication with physician: no explant of device; no autopsy planned. Based on programmed settings, the generator was nearing expected end of service, however, the test results indicate it was delivering the programmed output.  
  
Event Description  
Describe event or problem: pt death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=318647


« Last Edit: July 27, 2013, 04:34:23 AM by dennis100 » Logged
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« Reply #23 on: July 25, 2010, 10:37:03 PM »

Event Date 05/23/2004
Event Type  Death   Patient Outcome  Death;  
Event Description  
Reporter indicated that vns pt had passed away. Treating physician indicated that the pt experienced cardiorespiratory arrest at home two days prior to death that was possibly a consequence of their repeated tonic seizures. The pt died while hospitalized. It was reported that the pt experienced a >50% reduction in seizures with the vns therapy and was receiving therapy at the time of death. In the 12 months prior to death, the pt experienced multiple generalized seizures daily. Treating physican indicated that the cause of death was not related to the ncp system. 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=533003

« Last Edit: July 27, 2013, 04:35:09 AM by dennis100 » Logged
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« Reply #24 on: August 04, 2010, 01:14:00 AM »

Event Date 09/24/2007
Event Type  Injury   Patient Outcome  Hospitalization; Required Intervention  
Event Description  
Initial reporter indicated the pt had "full revision surgery" and postoperatively experienced "an instance of asystole and the vns had to be programmed off. She said that they only had one episode of asystole and the vns was disable, did not think any meds were given for it but was not sure. The pt came out of it spontaneously. " the event of "full revision surgery" was reported on medwatch #16444487-2007-01713. Good faith attempts are being made to obtain additional information.

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=931642

« Last Edit: July 27, 2013, 04:36:57 AM by dennis100 » Logged
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« Reply #25 on: August 04, 2010, 11:10:03 AM »

Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Life Threatening;  
Event Description  
Reporter indicated that an asystole event had occurred. No other information is available at this time. All attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1222464
« Last Edit: July 27, 2013, 04:37:45 AM by dennis100 » Logged
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« Reply #26 on: October 09, 2010, 12:01:16 PM »

Event Date 08/01/2010
Event Type  Injury   Patient Outcome  Required Intervention;  
Event Description  
It was reported to the manufacturer by the patients treating neurologist that the pulse generator, when tested at a recent follow-up visit, was showing that the device was nearing end of service as the elective replacement indicator (eri flag) was set to yes. The neurologist reported that diagnostic testing revealed normal device function, but that the device eri was set to yes. The physician further explained that the patient has been experiencing an increase in seizure frequency and it was also noted that the patient has been experiencing asystole events, which occur up to 9 seconds with seizures. The physician noted that there is always some prolongation of the asystole with every seizure, but may not always be that long. She noted also that the cardiac event did not seem to be when the vns device stimulates, but rather when the patient has seizures. The physician indicated that the patient is new to her practice, and the asystole was found 'unexpectedly'. The physician explained that it may be that because the generator is nearing end of service, so patient is having more seizures and thus having more asystole events. The patient had surgery where the generator was replaced, and the asystole events have continued per the physician. The physician explained that the patient also had a cardiac pacemaker placed and was discharged home. The plan is to admit the patient to the epilepsy monitoring unit with simultaneous holter monitoring. Good faith attempts to obtain additional information regarding the believed relationship of the cardiac event to vns are currently underway. In addition, good faith attempts to obtain the explanted pulse generator returned to manufacturer for analysis have been made, but the device has not been returned to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1839744
 
« Last Edit: July 27, 2013, 04:39:35 AM by dennis100 » Logged
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« Reply #27 on: December 26, 2010, 01:33:36 AM »

Event Date 06/27/2010
Event Type  Injury   Patient Outcome  Hospitalization; Required Intervention  
Event Description  

Information was received that a vns patient was admitted to hospital for bradycardia and syncope. It was reported that the patient has recently had many episodes of syncope. They also noticed the patient had pauses on the cardiac monitoring. These pauses are erratic, lasting about 3 sec and does not coincide with stimulation. They placed the magnet over the generator for 24 hours and during that time, they didn't see anymore cases of heart pauses. No vns setting changes were made prior to the onset of the events. The patient was set at 1. 25/30/250/21/0. 5 so, a 49% duty cycle. The patient was discharged from the hospital on (b) (6), and there were no further incidents of the heart pauses or syncope, and the event was not duplicated again on the cardiac monitoring equipment. The cardiologist recommended having the patient wear a holter monitor for 20 days to monitor cardiac activity, and will re-assess the patient at that time. The device remains programmed on and per the physician he tested the device following the onset of the events, and it is operating within normal limits. The cause of the syncope and the irregular heart pauses is unknown at this time. It was reported that the patient had a myocardial infarction (mi) in (b) (6) 2010, and at that time he was put on a beta blocker medication. It is unknown if stimulation may be a contributory factor to the recent events, but their treating physician should have more information after (b) (6). Good faith attempts to obtain additional details have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1775112

 
« Last Edit: July 27, 2013, 04:42:02 AM by dennis100 » Logged
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« Reply #28 on: January 07, 2011, 11:55:40 PM »

Event Date 06/26/2002
Event Type Death Patient Outcome Death;
Event Description
In the process of contacting the patient to notify them that their device may be nearing end of service, it was discovered that the patient had passed away. Autopsy report attributes cause of death to sepsis and respiratory failure with multi-organ damages including hepatic central lobular necrosis, adrenal necrosis, acute tubular necrosis, and diffuse pulmonary intra-alveolar interstitial fibrosis. There is no evidence at this time that the ncp system caused or contributed to the reported event. Further investigation revealed that the patient was hospitalized from 05/02 until the date of their death. The patient was taken to the emergency room by their mother in 05/02 for a sore throat, difficulty breathing, "making sounds" (stridor) for three days intermittently. The patient was intubated in the emergency room, during which a mass completely obstructing the left main stem bronchus was visualized and biopsies of the mass were performed with follow-up laser therapy. The patient aspirated during this initial procedure. Post-operatively, patient's respiratory status declined. Patient was subsequently reintubated and the mass was debulked to ventilate the left lung with rigid bronchoscopy. Once the rigid bronchoscope was withdrawn, attempt to reintubate the patient was unsuccessful and an emergent cricothyroidotomy was performed. Possibly one of the internal jugular veins and the esophagus were partially lacerated in the event. During the procedure, the patient developed bradycardia, asystole and ventricular tachycardia requiring electrical defibrillation to restore sinus rhythm. Patient was subsequently transferred to the intensive care unit. The transbronchial biopsies of the left main stem bronchus mass done during this hospital admission was determined to be from a squamous papilloma with severe dysplasia. The patient's hospital course gradually worsened with adult respiratory distress syndrome, sepsis, and intractable seizures. Although patient's multiple blood cultures continued to be negative for organism, their urine and respiratory sputum samples grew enterobacter cloacae and candida albicans. Patient developed bilateral pneumothoraces and chest tubes were placed. The patient also developed a deep venous thrombosis in the left common femoral vein as determined by doppler ultrasound and was given anticoagulant prophylaxis. Patient's respiratory status continued to deteriorate and their family decided to change code status to no code. The patient suffered cardiopulmonary arrest and was pronounced dead in the hospital 5 weeks later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=418268

« Last Edit: July 27, 2013, 04:44:20 AM by dennis100 » Logged
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« Reply #29 on: January 08, 2011, 12:53:24 AM »

Event Date 08/04/2001
Event Type Death Patient Outcome Death;  
Event Description
Reporter indicated that patient had passed away. It was also reported that patient had received significant benefit from the vns. The patient went into intractable status epilepticus with subsequent cardiac arrest in 2001. Patient required cardiac resuscitation en route to emergency room, then cardioversion for 45 minutes; subsequently became hypotensive and brain dead.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=351098
« Last Edit: July 27, 2013, 04:44:59 AM by dennis100 » Logged
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