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Author Topic: Increase/Worsening of Seizures  (Read 312894 times)
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dennis100
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« Reply #3450 on: October 06, 2017, 02:45:10 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 08/28/2017
Event Type  Injury   
Event Description
Report received that a patient was admitted to the icu due to an increase in seizures. The patient's vns settings had been increased prior to experiencing the increase in seizures. System diagnostics had reportedly been taken while the patient was admitted and indicated the device was working as intended. Although the patient's former neurologist reportedly indicated the increase in seizures was due to induced stress from the patient's son dying a year prior, the patient's current neurologist did not know the reason for the increase in seizures. Since the patient has been seeing the current neurologist for about a year, his assessment indicates the cause of increased seizures is unknown. The patient's current neurologist decreased the vns settings back to original values. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6888270
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dennis100
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« Reply #3451 on: October 06, 2017, 02:45:46 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 08/01/2017
Event Type  Malfunction   
Event Description
The patient reported that she was experiencing an increase in seizures and that her physician's assistant wanted her to go for monitoring. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6878849
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dennis100
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« Reply #3452 on: October 06, 2017, 10:28:59 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 08/08/2017
Event Type  Injury   
Event Description
It was reported that a vns patient was experiencing an increase in seizures. The device was re-programmed and the seizures got worse. The patient is going back to the physician for further programming. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6838702
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dennis100
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« Reply #3453 on: October 06, 2017, 10:29:28 AM »

Model Number 102R
Device Problem No Known Device Problem
Event Date 03/08/2017
Event Type  Injury   
Event Description
It was reported through clinic notes that the patient was having an increase in seizures and needed a new generator. The patient was referred for a prophylactic vns generator replacement. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6849937
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dennis100
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« Reply #3454 on: October 06, 2017, 10:30:15 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/01/2016
Event Type  Injury   
Event Description
Clinic notes indicate that the patient has had a slight increase in seizure frequency since last vns setting change. Additional relevant information has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6856512
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dennis100
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« Reply #3455 on: October 06, 2017, 10:30:49 AM »

Model Number 103
Event Date 11/18/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported from clinic notes received on 01/22/2016 that the patient had a change in seizure pattern in (b)(6) 2015. Notes dated (b)(6) 2015 state that the patient has worsened since last visit. Follow-up with the physician showed that impedance values were within normal limits at the time of the worsening seizures. The physician indicated that the worsening seizures were not worse in frequency but more in intensity and her generalized tonic clonic seizures have involved more widespread body regions and are more severe. The physician increased the current on (b)(6) 2015 because of this condition.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6864304
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dennis100
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« Reply #3456 on: October 07, 2017, 02:12:55 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 03/23/2017
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2017 that the patient has been experiencing increased depression, increase seizures and more intense seizures since having vns surgery in (b)(6). No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6869470
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dennis100
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« Reply #3457 on: October 08, 2017, 08:52:25 AM »

Model Number 103
Event Date 01/01/2013
Event Type  Injury   
Event Description
A letter was received from the treating vns physician who reported that the physician is not aware of any evidence implicating that the patient's vns caused a cardiac dysrhythmia. The patient had structural abnormalities (as described in her ep study) that responded well to the ablation procedure on (b)(6) 2013. Since he is not convinced that there is a correlation between her cardiac rhythm and her vns, he was unable to provide additional information.
 
Event Description
A cardiologist reported that the vns patient was going to undergo a cardiac ablation to correct an arrhythmia. She indicated that the arrhythmia may be related to vns but it also be related to the patient's seizures. She was not certain. Follow-up was performed with the cardiologist following the cardiac ablation. Clinic notes dated (b)(6) 2013 reported current diagnoses of seizures with epilepsy, syncope and collapse, and palpitations. The patient was noted to have ongoing problems with seizures progressing so the treating vns physician contacted the cardiologist. The patient was evaluated by the physician and cardiologist in the hospital and had a monitor. In spite of all of the efforts, she has was having ongoing seizures. She also was having palpitations on an almost daily basis which last up to 30 minutes. She had a treadmill stress test on (b)(6) 2013 and it did not show any evidence of ischemia. She did have questionable atrial arrhythmias on the treadmill at maximal stress. On her event monitor last summer, she had episodes of underlying sinus rhythm and she did have repeated episodes of atrial arrhythmias with atrial cycle lengths around 200 ms, some of which looked like flutter and some more looked like atrial fibrillation. Her rate would be in the 100-120 range. She said she was not taking anything at the time including an episode where her heart rate went to 150, and she says that she was absolutely not doing anything that would have caused that from a physiologic standpoint. Her echocardiogram last (b)(6) showed normal left ventricular function with no significant abnormalities. The vns physician indicated to the cardiologist that if nothing can be offered from a cardiac standpoint, she will need to see a neurosurgeon to resolve the issue. Review of the ecat strips, which the vns physician has performed on his patients who have underlying sinus bradycardia, with rates in the 60s and then tachycardia with rates around 100-120 with a:a intervals at times that look consistent with atrial flutter or atypical coarse atrial fibrillation. The patient has no previous history of significant trauma, and no previous interventional or invasive cardiology procedures. The patient had an event monitor in (b)(6) 2012, echocardiogram (b)(6) 2012, treadmill test (b)(6) 2013; left ventricular ejection fraction: via echo. Cardiac analysis shows regular rhythm, s1 and s2 normal, no s3 or s4, apical impulse not displaced, no murmurs, no gallops, and no rubs detected. The cardiologist's impression indicated atrial arrhythmias, possible atrial flutter, and palpitations. The patient had a scheduled electrophysiology study and possible ablation scheduled for the next week. The cardiologist suspected that the patient may have a tendency to atrial fibrillation. The patient had (b)(4) study for atrial arrhythmias, possible atrial flutter, syncope, seizures, palpitations, normal lv fxn, and vns. She had successful ablation for avnrnt and aflutter. Follow up was indicated for patient to have a 24 hour holter monitor in 2 months with office visit to follow in 3 months. Additionally, the cardiac cath report dated (b)(6) 2013 was received. She was "referred as she was having clinical events of tachycardia related to her seizure medications. At this point intervagal nerve stimulator at this point. She is also having recurrent symptoms that are concerning for possible arrhythmia, and monitors have shown abnormalities including tachycardia consistent with an arrhythmia, possibly atrial flutter. If there is not an arrhythmogenic component to her symptoms, then it is felt that she would be facing neurosurgery to try and address the focus of her seizures. Subsequently, after discussion and documentation of arrhythmias, she has elected to proceed with ep study and possible ablation. It is felt that if there is no arrhythmias induced, then the following consideration would be anatomical ablation of atrial flutter". During the ablation procedure, "atrial tachycardia was seen that had rates of 140 beats per minute. Due to this uncertain clinical scenario as it should not be reinduced. The patient underwent successful ablation for two forms of psvt (avnrt and aflutter). The cardiologist indicated in the notes that it is believed the patient was having both of these arrhythmias clinically and would benefit from ablation. The patient's medications were continued at that time. Attempts for additional information regarding these events to the treating vns physician have been unsuccessful to date. The relationship of the arrythmia, increased seizures and syncope to vns are unclear to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3018075
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dennis100
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« Reply #3458 on: October 09, 2017, 01:21:40 AM »

Model Number 102
Event Date 02/15/2013
Event Type  Injury   
Event Description
Reporter indicated that a patient had increased seizures following vns generator replacement surgery on (b)(6) 2013. The patient was admitted to the hospital icu for his seizures. The vns was turned on at implant. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2993167
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dennis100
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« Reply #3459 on: October 09, 2017, 01:22:22 AM »

Model Number 103
Event Type  Injury   
Event Description
It was reported that a physician had questions concerned end of life battery statuses. Initial attempts to clarify were unsuccessful. No issues behind this question were presented. Follow-up with the physician showed that the patient's parents had the impression that it did nothing more. This was clarified to mean that the patient experienced an increase in seizures. The patient's settings were okay and had not been adjusted for one year. The duty cycle was increased on (b)(6) 2013. If no improvement was seen in 2-3 weeks, the settings would be adjusted again. It was stated that there were no problems with the patient's generator. Attempts for additional information and clarification have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2992749
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dennis100
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« Reply #3460 on: October 09, 2017, 01:23:12 AM »

Model Number 102
Event Date 12/01/2012
Event Type  Injury   
Event Description
It was initially reported that the patient was having an increase in seizures unknown by the physician if it was worse than prior to vns. It is unknown if the seizures are related to vns. The patient had off time decreased to 1. 8 minutes from 3 minutes. Good faith attempts for more information have been unsuccessful to date.
 
Event Description
Additional information was received that product analysis was competed on the generator. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.
 
Manufacturer Narrative

Event Description
Additional information was received that the patient had a generator replacement. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2991750
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« Reply #3461 on: October 09, 2017, 01:23:58 AM »

Model Number 102
Event Date 04/25/2012
Event Type  Injury   
Event Description
Reporter indicated a vns patient was admitted to the hospital on (b)(6) 2012 due to increased seizures and aspiration pneumonia. The patient received antibiotics. The patient was discharged from the hospital on (b)(6) 2012. All attempts to the reporter for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2995057
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« Reply #3462 on: October 09, 2017, 01:24:44 AM »

Model Number 104
Event Date 04/01/2011
Event Type  Malfunction   
Event Description
Clinic notes received on (b)(4) 2013 noted that the patient experienced an increase in seizures in (b)(6) 2011. It was noted that the patient had nine seizures in (b)(6) 2011, which was an increase from (b)(6) 2011 when the patient was noted to have less than 4 seizures. The clinic notes indicated that the increase in seizures continued and the patient experienced fifteen seizures in (b)(6) 2011, twelve seizures in (b)(6) 2011, ten seizures in (b)(6) 2011, 6 seizures in (b)(6), eighteen seizures in (b)(6) 2012, eleven seizures in (b)(6) 2012, eighteen seizures in (b)(6) 2012, fourteen seizures in (b)(6) 2012, and eight to nine seizures in (b)(6) 2012. On (b)(6) 2012, the patient's seizures were noted to be worse. The clinic notes indicated that the patient experienced a change in seizures in (b)(6) 2012. It was noted that although the patient's seizures were less frequent, the seizures were getting longer. It is unknown whether or not the increase in seizures if above the patient's pre-vns baseline frequency. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
The physician indicated that no additional information would be provided as he did not believe there was anything wrong with the patient's device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2995322
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dennis100
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« Reply #3463 on: October 09, 2017, 01:25:42 AM »

Model Number 103
Event Date 02/29/2012
Event Type  Malfunction   
Manufacturer Narrative
Review of programming history.
 
Event Description
Clinic notes dated (b)(6) 2012 indicated that this vns patient previously had 1-2 seizures per week but as now having 25 seizures per week. They were typically stiff seizures with tremors last 40 seconds. The patient's settings on (b)(6) 2012 are available, and system diagnostics from the date of clinic notes are within normal limits. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2995513
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dennis100
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« Reply #3464 on: October 10, 2017, 03:08:29 AM »

Model Number 101
Event Type Malfunction
Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported by the patient that the neurologist referred her for prophylactic battery replacement in anticipation of eos. In addition, the patient reported that she is experiencing an increase in seizures. The patient has been seen for a consult visit; however, no surgery has been scheduled. Attempts have been made for additional information; however, the physician stated that this patient has been lost to follow up. No other information has been provided.

Event Description
It was reported that the patient would be scheduled for surgery on (b)(6) 2013; however, upon performing diagnostics on the device, it was found that the patient has about four more years of battery life left. As the battery was found not to be nearing end of service, the surgery was cancelled. It was found that the patient is currently programmed at 0. 25ma output current. The physician stated that he has not considered increasing this output current as he believes the patient is receiving efficacy at these settings due to "substantial"; data available. No other information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3001610
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« Reply #3465 on: October 10, 2017, 03:09:13 AM »

Model Number 102
Event Date 03/02/2013
Event Type Malfunction
Event Description
It was reported by the patient that she is experiencing an increase in seizures and that she has also been experiencing stronger stimulation at times and then weaker stimulation. Attempts to contact the physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3086352
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« Reply #3466 on: October 10, 2017, 03:10:02 AM »

Model Number 102
Event Date 11/01/2012
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient noticed that her generator was not working when using the magnet for stimulation and was experiencing an increase in seizures from 1-2 seizures per day to 4-5 seizures per day. Attempts to contact the physician have been unsuccessful. The patient was scheduled to have her generator replaced, however, when the patient was seen by the physician the generator was interrogated and the battery was not at end of service. The surgery was then placed on hold for 6 months.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3086355
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« Reply #3467 on: October 10, 2017, 03:10:48 AM »

Model Number 102
Event Date 03/29/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient had an increase in seizures after the vns generator replacement. The nurse stated that the patient was stable after the generator replacement, but also mentioned that the patient had increased seizures because the vns generator might have been too high. The physician's office refused to provide additional information regarding this event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3078876
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« Reply #3468 on: October 11, 2017, 02:41:58 AM »

Model Number 102
Event Date 01/01/2010
Event Type Malfunction
Event Description
Clinic notes received into on (b)(6) 2016 contain relevant information on the reported increase in seizures. The timing of the notes identifying an increase in seizures approximately 8 months after implant. The physician attributes the increase in seizures to patient illnesses.

Event Description
It was reported that the patient had increase in seizures in 2010. She had 3 seizures per week after having 3-4 per month. It was reported that after removing a glioma from the left ear her seizure control was better. The patient had a prophylactic vns generator replacement performed on (b)(6) 2013. Attempts to contact the physician for information for the event have been unsuccessful to date. A battery life calculation was performed and the generator was found to be at 1. 96 years remaining until end of service.

Event Description
Attempts were made to return the explanted vns generator but the site does not return explanted products.

Manufacturer Narrative
Adverse event, corrected data: initial report inadvertently reported that the event was both an adverse event and malfunction; however, adverse event should not have been selected. If explanted, give date, corrected data: initial mdr mistakenly reported the device explant which is unrelated to the patient¿s increase in seizures and should not have been reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3044697
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« Reply #3469 on: October 11, 2017, 02:42:48 AM »

Model Number 102
Event Date 07/01/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
It was initially reported in clinic notes that the patient had an increase in seizures (b)(6) 2012. It was reported by the mother that the patient had 37 seizures in (b)(6). In the past when the patient was having difficulties she used ativan over a few days and the mother was given a prescription for ativan. The patient was reported to have been doing well since (b)(6) at the next appointment. The patient has a history of having an increase in seizure in (b)(6) and the week before her period. The patient is prescribed and administered dilantin (b)(6) to help with the (b)(6) seizures. They had taper the dilantin off in (b)(6) over 9-10 days. Good faith attempt for additional information have been unsuccessful to date. Her current neurologist responded to attempts but he did not know any information and review the clinic notes but was unable to provide any additional information. The current neurologist is in the same office the patient's former neurologist.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3065719
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« Reply #3470 on: October 11, 2017, 02:43:59 AM »

Model Number 102R
Event Date 03/19/2013
Event Type Malfunction
Event Description
Product analysis on the second vns generator returned was completed. The vns generator was returned due to non-compatibility with the m300 lead, and was not used. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

Event Description
It was reported that the patient is having increase in seizures and pain in her generator's site. The patient had 11 seizures in february and march, and also reported that she would feel pain from the generator site to the neck and is unsure if it occurs with stimulation. The physician believes that this might be due to a battery problem with the vns generator and has referred the patient to a surgeon. A battery life calculation was performed on (b)(6) 2013 and it showed 1. 11 years till end of service.

Event Description
New information was received that the patient underwent surgery on (b)(6) 2013 to replace the vns generator but upon spotting fluid inside the vns lead the surgeon performed a full revision. This event has been reported in mdr report # 1644487-2013-01666. The explanted vns generator was returned to the manufacturer for product analysis and it was received on (b)(6) 2013.

Event Description
An implant card was received on (b)(6) 2013 stating that the vns generator was replaced due to propylacetic replacement. Product analysis on the explanted generator was performed. The generator's septum was not cored which eliminates the possibility of a potential unintended electrical current path through body fluids. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications.

Manufacturer Narrative
Follow up report number one stated that the vns generator was returned on (b)(4) 2013. Both vns generators were actually received on (b)(4) 2013. The second generator was explanted due to lead compatibility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3066804
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« Reply #3471 on: October 12, 2017, 01:42:03 AM »

Event Date 01/01/1996
Event Type Injury
Event Description
An article entitled ¿promising effect of vagal stimulation in (b)(6) patients with epilepsy¿ was received. The aim of this study was to evaluate the effect of vns on seizure frequency and to investigate patient satisfaction of and quality of life effects of vns treatment. (b)(4) patients were reviewed between 1996 and 2006. (b)(4) patients experienced a reduction in seizure frequency and (b)(4) of adults reported a positive effect on quality of life with a benefit on long-term treatment. Around (b)(4) also reported a positive effect on quality of life measure like copying, mood, self-confidence, and social abilities. In the children¿s group, (b)(4) report a positive effect on quality of everyday life for the child and the family, (b)(4) reported no change and (b)(4) a negative effect. The patients had mild side effects, expect for one case of vocal cord paralysis. Results also indicated that two children were reported as having suffered an increase in the frequency of seizures. Another patient had the vns removed due to mental side effects and experienced an increase in the frequency of seizures. Additional side effects included one case of infection, behavioral changes, hoarseness with stimulation, stimulation dependent dyspnea upon exertion, cosmetic complains, loss of singing ability, difficulties swallowing, difficulties speaking, and red, wide, or itchy scars. The authors suggest that the loss of singing ability could be due to vocal cord paralysis or hoarseness. This report captures the report of infection: mfr report #1644487-2013-01463. One increase in seizures is captured mfr report #1644487-2013-01462. Another increase in seizures is captured in mfr report #1644487-2013-01461. The increase in seizures with mental side effects is captured in mfr report #1644487-2013-01460. The vocal cord paralysis is captured in mfr report #1644487-2013-01459. The report of loss of ability to sing possibly due to vocal cord paralysis is captured in mfr report #1644487-2013-01464.

Manufacturer Narrative
Thygesen ks, sabers a. Promising effect of vagal stimulation in (b)(6) patients with epilepsy. Dan med j. 2013;60(3):a4597. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3121271
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« Reply #3472 on: October 12, 2017, 01:43:00 AM »

Event Date 01/01/2012
Event Type Injury
Event Description
Additional information was received that all of the reported adverse events (except for the cardiac event) were mild, temporary, and overall in line with the experience.

Manufacturer Narrative
Ryzi m, brazdil m, novak z, chrastina j, oslejskova h, rektor i, et al. Long-term vagus nerve stimulation in children with focal epilepsy. Acta neurol scand. 2012. http://Http://www. Ncbi. Nlm. Nih. Gov/pubmed/22994298.

Event Description
An article entitled ¿long-term vagus nerve stimulation in children with focal epilepsy¿ was received. The article reviewed one and two year efficacies of 15 patients implanted with a therapy system. Of the 15 patients, 7 were responders at one year after implant, nine were responders at two years after implant, and nine were responders at five years after implant. Initial settings were provided. The output current was increased in two week increments of 0. 25 ma to a target intensity of 01. 50 ma to 2. 0 ma depending on efficacy and the presence of side effects. Rapid cycles (on time: 3. 0 seconds, off time: 1. 8 minutes and on time: 7 seconds, off time: 18 seconds) was used in all patients who were classified as non-responder at one year. Medications were kept unchanged during the first six months. The article concluded that vagus nerve stimulation is an effective method of treating children with refractory focal epilepsy. It led to a substantial decrease in the number and duration of urgent hospitalizations. The article indicated that one patient experienced severe adverse effects requiring explant of the device. The patient experienced repetitive attacks of cardiac asystolia, sometimes associated with syncope at the time when the device was switched on. The syncopes started after more than one year of stimulation. The asystole was strictly related to the on status of the device and was not related to patient seizures. ¿ this was provided by video-eeg monitoring. The patient did not response to vns; therefore, the output current was not adjusted. The discontinuation of vns led to the complete cessation of these symptoms. The cardiological investigations performed on this patient both pre-operatively and post-operatively (during the off times) revealed no abnormalities. Other severe adverse effects were not observed. The explant due to cardiac events is captured in mfr report #1644487-2013-01439. Urgent hospitalizations were also reported for nine patients in the post-operative period. This was defined as hospitalization because of an increase in seizure frequency with a change or adjustment in the long-term aed treatment or because of an adverse event, a complication of the epilepsy itself, or an aed treatment that lead to any permanent therapeutic treatments. This report captures the urgent hospitalization for an increase in seizure frequency for patient 2 of 9. Additional reports are captured in mfr report #1644487-2013-01490, mfr report #1644487-2013-01493, mfr report #1644487-2013-01494, mfr report # 1644487-2013-01495, mfr report #1644487-2013-01496, mfr report #1644487-2013-01497, mfr report #1644487-2013-01498, mfr report #1644487-2013-01499 the article also noted that cough, hoarseness, and mild dysphagia were observed in 12 of the 15 patients reviewed. In none of these patient¿s was the severe effect a reason for discontinuation of vns, and the effect resolved completed by the next visit.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3122180
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« Reply #3473 on: October 12, 2017, 01:44:07 AM »

Model Number 105
Event Date 04/24/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
It was initially reported by the patient that he had two seizures the night after he had his vns turned on for the first time. The patient had only had 8 seizures since 2008 so the two seizures would be an increase above his pre-vns baseline. In the past the patient had seizures when he missed medications but he reported that he had been complaint with medications. The patient reported that he had to swipe the magnet multiple times but was successful able to stop both seizures. Follow-up with the neurologist indicated that they would not provide any information without a signed consent from the patient that we can release the information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3128482
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dennis100
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« Reply #3474 on: October 12, 2017, 01:45:08 AM »

Model Number 103
Event Date 05/18/2011
Event Type Malfunction
Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that the patient had been experiencing coughing, increased seizures, and hoarseness on (b)(6) 2011. The patient felt the cough and hoarseness with stimulation. The physician was unsure whether the seizures increasing were due to the vns. They were all resolved on (b)(6) 2011. Attempts for additional information have been made but no further information has been received to date.

Event Description
Additional information received on (b)(6) 2013 when it was reported that the physician did not believe that the patient¿s increase in seizures is related to vns therapy. No interventions were taken. The patient's settings on (b)(6) 2012 were stated to be: output current - 1. 5 ma, frequency ¿ 30 hz, pulse width ¿ 500 microseconds, on-time 30 seconds, off-time ¿ 5 minutes, magnet output current ¿ 1. 75 ma, pulse width - 500 microseconds, on-time ¿ 60 seconds, battery end of service status - ok. No interventions were taken or planned to preclude a serious injury. The physician stated that the relationship of the increase in seizure to pre-vns baseline levels is unknown. The patient does not have multiple seizure types. Causal or contributory programming changes, medication changes, or other external factors did not precede the onset of the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3031252
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dennis100
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« Reply #3475 on: October 13, 2017, 01:00:18 AM »

Model Number 103
Event Date 04/18/2013
Event Type Injury
Manufacturer Narrative

Event Description
Reporter indicated the drop seizures were not a new seizure type, and the level of the seizure increase is not known as the patient is relatively new to the office. The vns remains off at the mother¿s request. There has not been a change in the drop seizures or secretions since the vns has been off, but the mother prefers to keep it off for now. The patient will continue to be monitored clinically with the vns off. No other interventions are currently planned. It is not known what to attribute the drop seizures or secretions to.

Event Description
On (b)(6) 2013, it was reported by the patient's mother that the vns patient's device was turned off on (b)(6) 2012 due to complaints of dropped seizures, and other "unspecified adverse events". It was later reported on (b)(6) 2013 by the treating physician that the unspecified adverse events were related to the patient's experience of excessive saliva secretions. At this time the vns is still turned off, and the physician stated that she would like for it to stay off while the patient's medications were being adjusted. Attempts for additional information are currently in progress.

Event Description
The generator was explanted on (b)(6) 2016 and not replaced. The explant facility reportedly discarded the explanted generator.

Event Description
It was reported that a patient requested to have her vns system explanted due to pain caused by the presence of the device and lack of efficacy. Additionally, the reason for device disablement was noted to be that vns worsened the patient's seizure symptoms. It was noted by her physician that the patient was doing better without vns therapy. The caregiver requested device explant. However, explant intervention has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3109273
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dennis100
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« Reply #3476 on: October 13, 2017, 01:01:03 AM »

Model Number 102R
Event Date 05/17/2004
Event Type Malfunction
Event Description
It was initially reported that the patient had an increase in seizures after her second battery replacement. The patient was seizure free after her first generator replacement following her second generator replacement she has not been seizure free. The patient is currently having 5 seizures a week. It is unknown if the increase in seizures are above or below baseline or related to vns. Follow-up with the patient¿s current neurologist indicated that the physician did not feel the seizures were related to vns. This neurologist has only seen the patient once and prior to this the patient had not seen a neurologist for a few years. It was unknown by the office who the patient had seen previously that would be able to provide any additional information. A current primary care physician¿s name was provided and follow-up was done with that office. No additional information about the increase in seizures following generator replacement was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3118243
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dennis100
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« Reply #3477 on: October 13, 2017, 01:02:02 AM »

Model Number 102
Event Date 02/05/2013
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history.

Event Description
It was reported that this vns patient was experiencing a slight increase in seizures. The patient's settings were last adjusted on (b)(6) 2010. Follow-up showed that on (b)(6) 2013, in a routine follow up, the patient told the physician that he has had an increase in small seizures. The patient's baseline was a few times a month-to one per week. The patient explained that he also had a weight gain. No changes were made but diagnostics were performed. On (b)(6) 2013, the patient returned, and was noted to have had 2 generalized tonic-clonic seizures and two small seizures since the last visit. The device was interrogated, and diagnostics were within normal limits. Interventions included close communication between the patient and physician. A blc resulted in 0. 98 years remaining.

Event Description
Clinic notes dated (b)(6) 2013 indicate that the patient again experienced an increase in seizures. The relationship of the increase in seizures and vns therapy is unknown. It is unknown if the increase is above the patient's pre-vns baseline frequency. It was noted that the patient has experienced a 50 pound weight gain.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3110101
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dennis100
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« Reply #3478 on: October 13, 2017, 01:02:52 AM »

Model Number 102
Event Date 04/18/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
Reporter indicated a patient presented to the hospital with increased seizures. The reporter ¿did not have an opinion¿ on the relationship of the increased seizures to the vns device. The patient is no longer being seen by the reporter due to insurance reasons. The patient¿s caregiver also reported to the manufacturer that the patient¿s seizures were increased to above pre-vns baseline levels. The manufacturer assisted the caregiver in finding vns-treating physicians for the patient to check the vns, but it is unknown if the patient has followed up with anyone for care.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3113188
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dennis100
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« Reply #3479 on: October 13, 2017, 01:03:48 AM »

Model Number 102
Event Date 01/01/2013
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2013 from the neurosurgeon reported that the patient returned for her annual visit. When the patient was seen last in (b)(6) 2011, the patient was complaining of discomfort in the left side of her neck that had no particular relationship to any activity and was a stinging sort of pain that she had trouble defining more clearly. The patient indicated it lasts about 5-10 minutes. She reported at the (b)(6) 2011 visit that it did not have any relationship to her neck position or time of day and did not think that it was related to vns stimulation on-times. The patient presented again on (b)(6) 2013 with the neck pain which was described as a shock and stinging sensation. At this time, the patient once again reported that it was random and was unable to relate it to any specific time of day or vns stimulation on-times. The surgeon asked the patent to keep a record of the occurrence of pain to determine if it was occurring with vns stimulation, but the patient did not keep a log. The mother reported the pain continued but has not been severe and has been erratic in occurrence. Palpitation of the vns incision areas did not seem to cause any discomfort. Additionally, the patient denied any discomfort while performing lead diagnostic testing on the device. The patient¿s signal off-time was decreased from 15 minutes to 5 minutes, as the surgeon noted this was an excessively high off-time. However of greater concern noted in the surgeon¿s notes, the patent experienced an increased in her seizure frequency. She had seven seizures since the beginning of this year, whereas previously, she had only been having one a year. The patient had an increase in an anti-seizure medication in january via her neurologist. The mother reported that the seizures were general tonic-clonic seizures lasting approximately less than one minute. However recently with an increased seizure frequency, the mother noted a longer post-ictal. The patient and mother reported no recent illness, nor any other concerns at that visit. The nurse who dictated the surgeon¿s notes reported that treatment options would be discussed with the neurologist with regards to the increased seizure frequency and stinging sensation ¿likely due from her vns electrode. ¿ clinic notes dated (b)(6) 2013 from the neurologist reported that the patient suggested that her neck was quite uncomfortable at times. The device was programmed to 30 seconds on and 5 minutes off. The neurologist suggested to perform an x-ray to check the leads. The patient had generator replacement surgery on (b)(6) 2013, as captured in mfg report #: 1644487-2013-01969. Lead impedance following generator replacement was okay. The attempts for product return and potential product analysis of the generator will be captured in mfg report #: 1644487-2013-01969. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3197311
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