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Author Topic: Increase/Worsening of Seizures  (Read 890700 times)
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dennis100
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« Reply #4170 on: April 08, 2019, 03:16:35 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Event Description
It was reported that a patient who was implanted is being titrated biweekly and was doing better when she reached about 1. 0ma but still having 3-5 seizures/day compared to 10 seizures a day. Physician continued to increase current and when patient reached 1. 50ma-2. 0ma her seizures staring increasing dramatically, and the patient was hospitalized in the icu. Medications were adjusted and the current was decreased to 1. 0 ma. It was reported that the patient is doing better at these parameters and with the medication changes. The patient was diagnosed with ring chromosome 20. Information was received that the patient's increase in seizures was above pre-vns baseline levels. The physician thinks the seizures are related to vns stimulation especially since when she lowered it to 1. 0ma from 2. 0 her seizures decreased. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8403580
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dennis100
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« Reply #4171 on: April 08, 2019, 03:17:16 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/05/2007
Event Type  Injury   
Event Description
It was reported that a patient's device was turned off "10 years ago" as it did not help her, but actually increased her seizures. The patient also reported feeling discomfort from the device. Review of the manufacturer's programming history found no device diagnostics and noted that the device was turned off in 2007 after being titrated up to output current of 1. 25ma normal mode stimulation. No anomalies were noted. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8394341
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dennis100
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« Reply #4172 on: April 09, 2019, 12:59:55 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/15/2015
Event Type  Malfunction   
Event Description
Received clinic notes as part of the process for a prophylactic generator replacement referral. Clinic notes dated (b)(6) 2015 report that the patient had alleged that they feel that their seizure frequency has increased since getting the vns. The patient noted that magnets near the vns actually trigger their small seizures rather than reducing them. At this same appointment, the physician noted in their assessment that overall the patient's seizure frequency has been stable for the past 2 years. The physician also programmed the vns output current higher, and noted that the patient appeared to tolerate the adjustment well without adverse effects. There were several appointments following the patient's visit on (b)(6) 2015 where it is noted that the patient's vagal nerve stimulator appeared to be working well. Additionally, the patient had reported using the magnet a couple of times and it seems to be working well for them. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8389561
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dennis100
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« Reply #4173 on: April 09, 2019, 01:00:34 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/04/2019
Event Type  Injury   
Event Description
It was reported by a company representative that the patient was admitted to the hospital due to an increase in seizures. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8381699
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dennis100
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« Reply #4174 on: April 14, 2019, 01:50:09 AM »

Model Number 102
Event Date 01/27/2015
Event Type  Malfunction   
Event Description
It was reported on that the vns patient was experiencing an increase in seizures and that magnet mode stimulation was no longer effective in aborting seizures. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. A battery life calculation using the available programming history showed approximately 6. 7 years remaining. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
Further follow-up revealed that at the patient's visit on (b)(6) 2015 the physician indicated that the patient's medication dosages were to be adjusted due to the adverse events. The patient's mother was reluctant to have medication changes made at that time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532538
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dennis100
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« Reply #4175 on: April 17, 2019, 07:22:17 AM »

Model Number 102
Event Date 03/01/2015
Event Type  Injury   
Event Description
It was reported that the patient was experiencing an increase in seizures characterized by myoclonic jerking. These started approximately one year prior to the beginning of their mention in the clinic notes (date of notes was (b)(6) of 2016). The physician attributed the increase in seizures to battery depletion. The physician expressed he would seek generator replacement for the patient. Surgical intervention has not occurred to date. Follow up with the office of the treating physician¿s office showed that they suspected the battery to be low, but could not identify if the generator registered a low battery indicator at that time. Device diagnostics from that time could not be indicated. The patient was reportedly not taking any antiepileptic drugs, but this was not a recent change and could not be linked to the increase in seizures. No other relevant information could be provided at that time.
 
Event Description
The patient's generator replacement surgery occurred on (b)(6) 2016. Prior to explant, the patient's battery was reported to not be at end of service, and the device diagnostics were within normal limits. The explanting facility does not return explanted devices; therefore, product return attempts could not be completed. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5947422
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dennis100
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« Reply #4176 on: April 24, 2019, 03:08:28 AM »

Model Number MODEL 250
Device Problems Computer Software Problem; Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2012
Event Type  Malfunction   
Event Description
It was reported that on (b)(6) 2016 a vns patient experienced an increase in seizures and a decrease in perception 4 years ago in 2012. She had to escalate back up on levetiracetam though it is unclear if this is making any impact. " the device was stated it was not near end of service. The physician noted specifically that ¿ her current output is not consistent with her set parameters and that after 12 years of stimulation she was past the battery life¿ indicating he believes the battery may currently be depleting. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Generator replacement surgery occurred. The generator was received for analysis and was completed 01/18/2017. The report of low battery was not confirmed. During the analysis, there was no indication from the device that an end of service condition existed. The device output signal was monitored for more than 24 hours, 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 device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Follow-up from the physician provided that the intended output setting was 1. 25 milliamps, however it was started to be 1. 0 milliamps. The device settings were currently reported to be 1. 5 milliamps. The results of the most recent systems diagnostics were within normal limits. The patient¿s increase in seizures was not worse, but was the same as before she had vns, at 3-4 per week.
 
Event Description
Further follow-up from the physician provided that the current output that was not consistent with the set parameters was observed after an interrogation check. The physician stated that it was believed the battery was near end of life. The that the incorrect output current after interrogation of device settings provides evidence that the cause of the incorrect output current was due to a faulted systems diagnostic test, and may be related to the increase in seizures and decrease in perception experienced by the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6189981
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dennis100
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« Reply #4177 on: April 26, 2019, 07:00:09 AM »

Model Number 103
Event Date 07/03/2008
Event Type  Malfunction   
Event Description
It was reported that the patient has experienced a marked increase in seizures with vns therapy. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3388605
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dennis100
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« Reply #4178 on: May 01, 2019, 01:17:08 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/04/2018
Event Type  Injury   
Event Description
It was reported that a patient was experiencing an increase in seizures. It was stated that the system diagnostics performed with the patient's head turned in different directions were within normal limits. X-rays were reviewed and noted no obvious fractures or sharp angles. Based on the images provided, there was no obvious cause for the increased seizures and no apparent malfunction. No further relevant information has been received to date.
 
Manufacturer Narrative
Corrected data: initial report inadvertently reported the event as a product problem instead of an adverse event. Outcomes attributed to adverse event, corrected data: initial report inadvertently did not report the outcomes of the adverse event. Describe event or problem, corrected data: initial report inadvertently did not include the device disablement. Type of reportable event, corrected date: initial report inadvertently reported the event as a malfunction instead of a serious injury.
 
Event Description
It was reported that the patient's autostimulation was programmed off when the increased seizures occurred, and the device was later turned off completely. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7551331
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dennis100
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« Reply #4179 on: May 03, 2019, 03:41:06 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/25/2011
Event Type  Injury   
Event Description
It was reported via clinic notes that a vns patient was experiencing an increase in seizures. The patient was referred for surgery. The physician stated the generator was interrogated and confirmed the device "is functioning well". Follow-up from the patient on (b)(6) 2017 also provide that she has had issues with different seizure types and frequency since last replacement. She stated seizures now happen every 2 weeks when they were happening every 4-5 weeks, lasting up to 2. 5 minutes and her recovery can be up to a week. Follow-up from the physician provided that the most recent diagnostics were normal with no error and the device was not at end of battery life. The patient¿s husband has reported increasing seizure frequency and severity past 3-6 months. The physician provided it is unclear if the increase in seizures was related to vns and mentioned the device is likely needing replacement. There is high suspicion for non-epileptic seizures co-existing with her epilepsy. Battery status indicator was reported to be normal. The change in seizure pattern and post-ictal duration is unclear if it is related to vns. It is suspected that the patient has pnes (psychogenic non-epileptic seizures) as well. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the patient provided that she was still experiencing seizures and that she can no longer feel the magnet swipe.
 
Event Description
Follow-up from the patient provided that the generator has migrated close to her armpit due to her weight loss and is bothersome. The patient reports that she has had increased seizures within the last year and does not feel the vns is working. The patient also stated she had a really rough week as she has had a lot of seizures.
 
Event Description
It was reported by the patient that her device was turning on every 10 seconds, and staying on for about 10 seconds. The stimulation was very strong and painful and making it difficult to swallow. She reported that generator location makes it difficult to access with the magnet to disable the device. It was indicated by the surgeon that the patient's replacement surgery was due to battery depletion and her migration would be fixed at this time. Per the surgeon, the surgery was not to preclude a serious injury. No surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
It was reported that the patient underwent replacement due to battery depletion. The explanted product was returned. The patient reported that she had been having sleep apnea, buzzing in her neck during sleep since 2011. She also indicated that she had felt stronger stimulation in her neck and that she gagged with magnet swipes which had led to weight-loss in the past. The patient's treating physician indicated that this patient was a high anxiety patient. It was found that the patient had multiple complaints requiring investigations of increased seizures, pain with stimulation, dysphagia with stimulation, and perception of stimulation since 2011 that were previously considered separate events. Three reports regarding seizures of this patient were submitted since 2011. In mfr. Report #1644487-2012-00443, the patient reported that she'd had an increase in seizures in january 2012, a tightness in her neck, a decreased range of motion of her neck, and pain and clicking in her throat with stimulation. The physician said that the patient's increased seizures were not related to vns. The physician stated that he believed that the patient¿s pain and ¿tightness¿ or limited range of movement, were psychiatric in nature and not related to vns. In (b)(6) 2015, mfr. Report #1644487-2015-04964, captures a report from the patient that she had a new type of seizure while having her vns settings adjusted. This seizure was later indicated not to be related by the physician and the physician indicated that the patient's seizures had decreased in severity since having the vns. Mfr. Report #1644487-2015-05446 reported that in (b)(6) 2015 the patient had experienced an increase in seizures due to her "levels being low. " the physician indicated that the patient had an extremely variable seizure pattern and that her history is not reliable. Further relevant information to these reports will be captured in the current manufacturing report as these reports appear to be related. No further relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: supplemental mdr 4 inadvertently reported that the generator was returned when it was actually discarded.
 
Event Description
The physician indicated that the relationship of the following symptoms---sleep apnea, buzzing in neck, stronger stimulation in her neck, and gagging with magnet swipes which had led to weight-loss in the past--- was unknown. The patient's explanted product was discarded. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6434722
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dennis100
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« Reply #4180 on: May 07, 2019, 07:45:30 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2016
Event Type  Malfunction   
Event Description
It was reported that the patient believed her vns battery was dying because she experienced an increase in seizures. The patient also reportedly had a seizure with a convulsion, which was stated to have never been experienced by the patient before. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6393405
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dennis100
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« Reply #4181 on: May 07, 2019, 07:46:18 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/20/2018
Event Type  Injury   
Event Description
The patient reported experiencing an increase in seizures and painful stimulation. Further information was received that the patient is referred for replacement. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8150439
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« Reply #4182 on: May 08, 2019, 10:53:38 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/24/2013
Event Type  Injury   
Event Description
It was reported that the patient's vns was programmed off for several years. Follow up with the physician's office revealed that the patient's parents thought that the vns was making seizures worse and wanted the vns explanted. The patient's notes from the date of the disablement were reviewed and indicated that the parent's did not think that the vns was helpful and that the patient was picking at the device. The vns was disabled as a result. 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=7314312
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« Reply #4183 on: May 10, 2019, 02:20:18 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/04/2019
Event Type  Malfunction   
Event Description
The patient's mother reported on (b)(6) that the patient has grand mal seizures all the time and that no physicians in the area are able to help them. This was determined to be an increase in seizures as the patient's pre-vns seizure rate was unknown. No patient could be identified by the reporter¿s full name. No further additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8562634
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« Reply #4184 on: May 10, 2019, 02:20:56 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/13/2019
Event Type  Injury   
Event Description
It was reported that the patient was experiencing an increase in seizures, which the patient's mother believed was related to low battery. A battery life calculation was performed with the programming data available to the manufacturer and estimated approximately 1. 7 years remaining until near end of service condition. Diagnostics showed that the device was functioning as intended and was expected to be delivering the programmed therapy. Clinic notes were received for the patient's referral for prophylactic replacement. No known surgery has occurred to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8468942
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« Reply #4185 on: May 10, 2019, 02:21:36 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2018
Event Type  Injury   
Event Description
Handwritten clinical notes were received which were mostly illegible, but a statement was observed stating the vns battery was found to be weak and the patient is having more seizures. The patient was referred for replacement due to this. Additionally, a battery life estimation was performed with the available data which resulted in >10 years until expected neos and did not support a depleted battery status. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8510942
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« Reply #4186 on: May 10, 2019, 02:22:16 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
A patient's mother posted a report via social media that her daughter had the vns implanted, and as a result the patient's seizures increased, she had complications from her incisions, and still has chest pain around the battery even though the vns has been turned off. The mother also noted that the increased seizure activity was observed while the vns was turned on, and that the patient will most likely never fully recover from the nerve damage. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8555408
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« Reply #4187 on: May 10, 2019, 02:23:03 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/25/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient's fiancé reported that the vns was turned up too high at the generator replacement surgery. It was noted that the patient's quality of life is not good, and at the "higher" output current the patient was feeling dizzy, nauseous, and "felt like having seizures", and she "felt like she is being overmedicated". Further follow up confirmed that the patient's generator output current was reduced as a result of the patient's symptoms, and that the patient's symptoms resolved after the parameter adjustment. The physician noted that the patient was feeling "poorly" due to pain and feeling like they were getting too strong of a stimulation. The physician reported that the patient experienced increased seizures due to being very stressed and very much in pain/discomfort, which stemmed from the vns output current being set too high. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8556724
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« Reply #4188 on: May 10, 2019, 02:24:20 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/26/2019
Event Type  Injury   
Event Description
It was reported that the patient was referred for prophylactic battery replacement and that the patient had experienced a lot of seizures. The physician had just began seeing the patient and was not aware of their pre-vns seizure baseline or external factors that may have been contributing to the increase in seizures. It was reported that the patient's settings were lowered. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8527029
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« Reply #4189 on: May 10, 2019, 11:57:53 PM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/06/2011
Event Type  Injury   
Event Description
It was reported by the patient¿s mother that her son has more seizures when his battery reaches 25%, and that the neurologist increases the keppra dose to counteract the seizures. The patient had generator replacements in 2007, 2011, 2015, and is scheduled for replacement currently. The increase in seizures in 2007 is reported under mfr. Report # 1644487-2007-01077, the increase in seizures in 2015 is reported under mfr. Report # 1644487-2019-00636, and the increase in seizures in 2019 is reported under mfr. Report # 1644487-2019-00652. This report concerns the increase in seizures in 2011 and subsequent generator replacement. The generator replacement was initially reported to be prophylactic. The explanted generator was later received by the manufacturer and an analysis was performed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Additionally, the generator¿s header was found to be detached, but based on the observed tool marks on the pulse generator case it is very likely that this occurred during or after the explant procedure. Other than the header anomaly, there were no performance or any other type of adverse conditions found with the pulse generator. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8491278
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« Reply #4190 on: May 10, 2019, 11:58:32 PM »

Model Number 106
Device Problem Under-Sensing
Event Date 03/01/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was admitted to the hospital for seizures. It was stated that the patient's new vns generator was programmed to the patient's previous vns' settings and that there were no autostim detections. The physician increased the autostim sensitivity parameter. It was unknown if the physician was attributing the increase to the vns generator's lack of autostim detections. The patient's previous vns generator had issues with detecting tachycardia events for autostim as well. The previous generator was received by the manufacturer and is pending product analysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8471156
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« Reply #4191 on: May 10, 2019, 11:59:21 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/11/2019
Event Type  Malfunction   
Event Description
It was reported that a patient was experiencing an increase in seizures following a battery replacement surgery, and the patient stated that this always occurs after a vns surgery. The device was programmed on and were at the patient's previous pre-surgery settings. Follow up with the physician's office indicated that there were no records that could be found or accessed regarding the patient experiencing an increase of seizures following any vns procedure. Further follow up was received from the physician's office after seeing the patient. It was uncertain if the increase in seizures were at, above, or below pre-vns baseline levels, but it was stated that they were worse than usual in the month before the vns replacement. Per the physician, the cause of the recent increase in seizures was not clear, but possibly related to surgery stress. The physician stated that they were not involved with previous vns surgeries, but it was reported that the patient had experienced an increase in seizures for 1 day. Settings and diagnostics were provided. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8485779
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« Reply #4192 on: May 10, 2019, 11:59:56 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/19/2019
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized due to an increase in seizure frequency and was referred for vns generator replacement. It was also reported that the patient's vns generator had not been checked over an extended period of time. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8493924
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« Reply #4193 on: May 11, 2019, 12:00:48 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/26/2019
Event Type  Injury   
Event Description
Clinic notes were received stating that the patient was starting to have nocturnal seizures. The increased seizures were suspected to be due to the device reaching neos condition. It was stated that vns was interrogated and settings were adjusted. Diagnostics were performed, however were not provided. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8530349
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« Reply #4194 on: May 11, 2019, 12:01:37 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/18/2019
Event Type  Injury   
Event Description
Initial report was that a patient had 6 drop seizures and that the patient was referred for a prophylactic full revision of the vns (replacement of the lead and generator). Further information was received from the physician's office that the cause of the increase in seizures was unknown, but that the patient had missed some medications. The relationship of the increase in seizures to vns baseline levels was unknown. The patient was referred for full revision as a result of the increase in seizures. Clinic notes received for the patient indicated that the vns was reprogrammed. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8514466
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« Reply #4195 on: May 11, 2019, 12:02:23 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/21/2019
Event Type  Malfunction   
Event Description
It was reported that a patient did not think their vns device was working as he was having many bad seizures and has reportedly had more since his replacement surgery. The patient's device was interrogated and diagnostics showed that the device was functioning as intended. No settings were adjusted for the patient. No additional, relevant information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8519846
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dennis100
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« Reply #4196 on: May 11, 2019, 12:03:16 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/18/2019
Event Type  Injury   
Event Description
It was reported that the patient has had an increase in seizures since the new device has been turned on. The patient presented seizures at the time of turn on and she does not tolerate the minimum parameters nor the system diagnostic. He decided to turn off and wait longer in case the nerve was affected at the time of manipulation during the lead placement. It was not possible to perform a post-operative system diagnostic because when they began the diagnostic the seizure came and the doctor orders to pull off the wand. Review of the device history record for the generator was completed. The device passed all specifications prior to distribution. The device history record was also reviewed for the implanted lead and the lead also passed all specifications. They have not tried to perform system diagnostics again since last time after surgery. The seizures increased only at the time of turn on the stimulator if vns is shut down the seizures are the same before the surgery. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8520377
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dennis100
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« Reply #4197 on: May 11, 2019, 12:04:00 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2016
Event Type  Injury   
Event Description
It was reported that a patient's generator had "stopped working after a year" and that the patient's seizures were worsening. The neurologist stated that the only thing they could do was possibly change the battery. A battery life calculation was performed with the data available to the manufacturer and did not confirm likely depletion. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8547828
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dennis100
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« Reply #4198 on: May 11, 2019, 12:04:43 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/03/2019
Event Type  Malfunction   
Event Description
The patient reported that she has a type of seizure (described by the patient as ¿alice in wonderland seizures¿) which is happening more recently. Patient reported that, per her physician, there is no cause identified. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8555692
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dennis100
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« Reply #4199 on: May 11, 2019, 12:05:23 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/29/2018
Event Type  Injury   
Event Description
It was reported that the patient was having an increase in seizures. The patient¿s device was at intensified follow up indicator at their latest appointment. The patient¿s seizures have been worse over the past year with 1-2 tonic-clonic seizures/month. The physician did not know the cause of the seizures, or if the seizures were above their pre-vns baseline frequency. Programming history was reviewed for the patient. No anomalies were seen. A battery life calculation was performed, and the device was expected to have 1. 3 years to near end of service. Surgery is likely but has not occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8528559
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