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Author Topic: Increase/Worsening of Seizures  (Read 630481 times)
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dennis100
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« Reply #3780 on: February 12, 2018, 02:15:11 AM »

Model Number 102
Event Date 08/14/2011
Event Type Injury
Event Description
Reporter indicated a vns patient had bradycardia and increased seizures on (b)(6) 2011. When the patient presented to the emergency room, the heart rate was 20-30 beats per minute. The patient was asymptomatic. The patient's normal heart rate is 70. The vns was disabled and the patient was hospitalized for observation. The vns was enabled on (b)(6) 2011 and the patient had bradycardia again and the vns was disabled. The patient has no personal or family history of cardiac events. The patient did have an increase in her keppra medication 60 days prior to the bradycardia event, which is believed to have possibly contributed to the bradycardia. It is unknown if the bradycardia is occurring with the vns stimulation on time, but the bradycardia did occur after a vns setting change from 1. 5ma to 1. 75ma output current on (b)(6) 2011. Telemetry and electrocardiography were used to confirm the bradycardia. The vns is related to the vns stimulation, and it is believed the vns exacerbated or co-currently contributed to the bradycardia. The patient was discharged from the hospital on (b)(6) 2011. The plan of care was to enable the vns again at lower settings, as the vns has been very helpful for the patient's seizures. Attempts for further information are in progress.

Manufacturer Narrative

Event Description
Manufacturer follow up with the reporter revealed the medication change in keppra is not related to the arrhythmias, and that the arrhythmias are believed to be due to vns stimulation. The vns will remain disabled for now, and may be turned on again in the future at low settings. The patient's seizures are intractable and part of her disease and are not related to the vns. The patient's seizures are not increased per the reporter.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2244186
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« Reply #3781 on: February 12, 2018, 02:15:48 AM »

Model Number 102
Event Date 08/11/2011
Event Type Malfunction
Event Description
It was reported by the pt's mother that she would like the vns removed because pt's seizures have gotten worse with vns. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2266764
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« Reply #3782 on: February 12, 2018, 02:16:32 AM »

Model Number 100
Device Problem No Known Device Problem
Event Date 03/24/1999
Event Type Malfunction
Event Description
It was reported by a patient¿s mother that when the vns was first turned on it made the seizures worse. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6820398
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« Reply #3783 on: February 13, 2018, 01:45:20 AM »

Model Number 101
Event Date 07/01/2008
Event Type Injury
Event Description
It was reported to the mfr that the vns pt has been experiencing an increase in seizure activity. The physician replaced the generator prophylactically because he beliveved it to be at end of service. Diagnostics performed on the generator revealed proper device function and generator was not at end of service. Good faith attempts to obtain the explanted generator for product analysis are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1130844
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« Reply #3784 on: February 13, 2018, 01:46:11 AM »

Model Number 103
Event Date 12/31/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
Additional information was received that the physician does not feel the increase in seizures are related to vns. The patient had a cold that the physician felt contributed to the increase in seizures.

Event Description
It was initially reported that the patient seizures were worse and were causing vomiting when the patient was turn on following implant per the patient's grandmother. Good faith attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2931295
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« Reply #3785 on: February 13, 2018, 01:47:04 AM »

Event Date 12/01/2011
Event Type Death
Event Description
Further information was received from the treating nurse indicating that no additional information was available regarding the reported events. This death event has been reviewed by the manufacturer and with the available information has been determined to be possible sudep. The only known factors are that the patient had epilepsy and died. As such, sudep cannot be ruled out as a cause of death.

Manufacturer Narrative

Event Description
It was reported by a company representative that a vns patient had passed away on (b)(6) 2011. The patient had not been seen for follow up visits since 2005, and was reported to be experiencing an increase in tonic clonic seizures. The patient was seen by a new physician in (b)(6) 2011 and a new aed was introduced. At the moment, the cause of death is unknown as the coroner has very few details and an autopsy is not available. Good faith attempts to obtain further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2389547
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« Reply #3786 on: February 14, 2018, 02:11:32 AM »

Model Number 102
Event Date 09/15/2011
Event Type Injury
Event Description
Further information was attained that reported the patient felt that the vns was giving her problems. These problems were never clarified by the patient to the site. As a result, the patient requested the device be explanted. Good faith attempts to obtain additional information have been unsuccessful to date. The relationship to their vns is unknown.

Event Description
The patient's explanted device was discarded; therefore, will not be returned for analysis.

Event Description
Additional information was received that the patient was not having increased seizures.

Manufacturer Narrative

Event Description
It was reported that a pt had increased seizures and had device explanted. Device was explanted on (b)(6) 2011 and no re-implant is scheduled. It is unk when the increase in seizures began. Good faith attempts to obtain add'l info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2282187
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« Reply #3787 on: February 14, 2018, 02:12:41 AM »

Model Number 105
Event Date 07/01/2014
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient's seizures have increased in intensity and quantity. The patient requested to see a new vns physician for possible change in settings or device explant. It is unknown whether or not the patient has been seen by one of the referred physician's. The patient indicated that she would get referral to the new physician by her primary care physician. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4733379
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« Reply #3788 on: February 14, 2018, 02:13:17 AM »

Model Number 102R
Event Date 04/10/2015
Event Type Malfunction
Event Description
It was reported that the vns patient was experiencing an increase in seizures. The patient¿s device was tested and diagnostic results showed normal device function. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4746462
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« Reply #3789 on: February 15, 2018, 03:06:10 AM »

Model Number 103
Event Date 09/23/2011
Event Type Injury
Event Description
It was reported that the patient was seen by a surgeon for explant of the vns due to the patient experiencing more seizures since implantation of vns. No surgery has occurred to date. Attempts for further information have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was reported that the patient underwent generator explant on (b)(6) 2011. The hospital discards explanted devices, so the generator cannot be returned to manufacturer for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2304405
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« Reply #3790 on: February 15, 2018, 03:06:52 AM »

Model Number 103
Event Date 01/01/2008
Event Type Malfunction
Event Description
It was reported by a patient implanted with vns for bi-polar depression that she started to develop seizures about 3 years ago and has had approximately 5 grand mal seizures this year. The patient stated that the frequency of her seizures appeared to be increasing and she wanted help finding a physician to check her device and help her gain control over her seizures. (b)(4) attempts to obtain additional information were unsuccessful as the patient did not make any appointments to have her device checked and her previous physician is no longer seeing her.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2396527
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dennis100
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« Reply #3791 on: February 16, 2018, 10:08:49 AM »

Model Number 103
Event Date 06/06/2011
Event Type Malfunction
Manufacturer Narrative

Event Description
Additional programming history, downloaded from the physician's handheld was received and reviewed. The only diagnostic test results available were from the date of implant, (b)(6) 2009 and revealed normal device function at the time. The data available ((b)(6) 2009 - (b)(6) 2011) was inserted into the generator decoder spreadsheet. It was noted that the device output current was increased from 3/30/500/30/5 to 3. 25/30/500/30/5 on (b)(6) 2011. The next interrogation took place on (b)(6) 2011 and review of the diagpeakcurrent on the decoder spreadsheet indicates that the output current being delivered was 3. 0ma where the programmed current was 3. 25ma. The data from the last 24hr impedance measurement indicates that the impedance was within normal limits at 2653ohms at the time. There were no diagnostic tests performed on (b)(6) 2011, nor were there any setting changes attempted. Similarly, upon interrogation on (b)(6) 2011, it was again noted that the current being delivered was 3. 0ma, whereas the programmed output current was 3. 25 ma. The impedance in october was 2490 ohms. Review of the generator source code indicates fluctuating impedance in the system is not likely a cause of the pulse generator's inability to deliver the higher programmed output current setting. Although lower than expected, the data indicates that the generator appears to be consistently delivering a certain amount of output current. The generator remains implanted in the patient, and no patient adverse events have been reported. The device history record was reviewed for model 103, (b)(4). The generator was manufactured in (b)(6) 2009. All lines were signed off indicating the device passed all inspections prior to shipment. There were no unresolved ncrs. The device passed all functional and electrical testing.

Event Description
It was reported that the physician received an error message while interrogating the patient's device. The error message stated that the programmed current was possibly not being delivered at the specified level "possibly limited by battery voltage, lead impedance or other reason". Diagnostics were not performed during this appointment and the patient has not been seen by the physician since the reported event. Attempts for additional have been unsuccessful to date.

Manufacturer Narrative
Analysis of programming history. Review of the generator source code indicates fluctuating impedance in the system is not likely a cause of the pulse generator's inability to deliver the higher programmed output current setting.

Event Description
It was reported that the patient had also experienced an increase in seizures that began around the time the error noted by the physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2318316
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« Reply #3792 on: February 18, 2018, 02:53:56 AM »

Event Date 01/01/2010
Event Type Malfunction
Manufacturer Narrative
Bibliography: lund, caroline, hrisimir kostov, berit blomskjøld, and karl o. Nakken. "efficacy and tolerability of long-term treatment with vagus nerve stimulation in adolescents and adults with refractory epilepsy and learning disabilities. " seizure (2010). Print.

Event Description
It was reported through a scientific article that a vns patient experienced some seizure deterioration due to unknown reason. At the moment good faith attempts to obtain further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2374709
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« Reply #3793 on: February 18, 2018, 02:54:56 AM »

Model Number 101
Event Date 06/07/2011
Event Type  Injury   
Event Description
A vns programming nurse reported to our country rep for the united kingdom that their vns pt has had a recent change to their seizures. The pt reports an increase in seizure activity over the last 3 months or so. Reported to be above their previous rate, but not a change in seizure type. The settings are current 1. 25ma, magnet current 1. 50ma with on time 30 seconds/ off time 5 minutes/signal frequency at 30hz and pulse width at 500 us. Eri/eos - no. Their device is still working after 10 years and 6 months and the pt's voice continues to be husky during stimulation - obvious in clinic (b)(6), 2011. The site is considering battery replacement but no date set at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2155977
« Last Edit: September 04, 2018, 08:40:46 AM by dennis100 » Logged
dennis100
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« Reply #3794 on: February 19, 2018, 01:28:12 AM »

Model Number 103
Event Date 01/01/2010
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by a neurologist that a vns patient did not experienced improvement with vns therapy and the patient's condition worsened due to unknown reason. A new aed was added to the patient's daily medications and the patient became seizure free. Further information from the neurologist indicated the patient does not perceive stimulation presently. Additional information from the reporting neurologist indicated that the lack of efficacy was found in late 2010 based on the lack of change in the frequency of crisis. Patient trauma is suspected to have occurred based on the patient's condition. The neurologist did not know if the lack of efficacy was due to the patient's condition or the time gap of the follow-ups to check and reprogram the vns. No clear relationship was made between the worsening crisis and the vns. No interventions are planned for the patient at the moment.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2336659
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« Reply #3795 on: February 20, 2018, 03:58:30 AM »

Model Number 102R
Event Date 05/05/2011
Event Type Injury
Event Description
Reporter indicated a vns pt was having a "significant increase" in seizures and had vns generator replacement surgery performed. The generator is not at end of service per the reporter. The explanted generator has been returned and is currently in product analysis. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2115025
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« Reply #3796 on: February 21, 2018, 02:37:09 AM »

Model Number 102
Event Date 07/13/2010
Event Type Injury
Event Description
Reporter indicated that a vns pt was having increased seizures, hearing loss, right eye drooping, and tiredness. The vns was reported to be functioning as intended per the reporter, and medication was adjusted as an intervention for the increased seizures. The cause of the reported events is unk, and the pt will follow up again on (b)(6) 2010 for further evaluation. Further attempts for information and the plan of care are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1898016
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« Reply #3797 on: February 25, 2018, 02:05:41 AM »

Model Number 102
Event Date 02/25/2008
Event Type Malfunction
Event Description
It was reported via clinic notes dated (b)(6) 2011 and received on (b)(6) 2011 that a patient implanted with a vns therapy system on (b)(6) 2008 reported that her seizures increased after the device was programmed on. The patient went from having 1 seizure per year to 1 seizure per month. The patient had the generator replaced on (b)(6) 2011. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2389398
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« Reply #3798 on: February 26, 2018, 02:17:59 AM »

Model Number 102
Event Date 01/19/2012
Event Type Malfunction
Event Description
It was initially reported by a nurse at the patient's school that the patient's mother felt that the "device had become dislodged"; however no details regarding what this meant were known. Additional information was later received from the patient's neurologist indicating that the patient has recently been having major behavioral issues. Recently during a behavioral outburst, he was assaulted by a security officer who was trying to detain him. The neurologist was concerned that there may be a disconnection on the lead now, as following the conflict with the security officer, the patient had bruising on his left chest. Also, since that incident, the patient cannot feel magnet stimulation, and magnet activations are not working to abort seizures. The patient has also started to experience an increase in seizures. Device diagnostics have not yet been performed as the patient has since been hospitalized due to the behavioral issues. The neurologist indicated that the therapy has helped with both the patient's seizures and behavioral issues, and they believe there is an issue with the device due to the increase in both. It is unknown at this time if there is an issue with the generator or the lead. Attempts for additional information are in progress.

Event Description
Additional information was received indicating that the device was checked on (b)(6) 2012 and was functioning properly. Diagnostic results were all ok. The patient had improved and has not experienced any more seizures since the time of the initial report. There was no migration or other issues with the device. The parents were initially concerned because of the bruising from the trauma, and they thought that there may be something wrong with the device because of this. The physician now believes that the increase in seizures was related to the trauma not to a vns malfunction. They also do not feel that the patient's behavioral issues are related to vns as the patient is autistic and is just getting stronger and is having more issues with age. The patient was also able to feel magnet stimulation again when the magnet was swiped on (b)(6) 2012. Since the patient is now doing well with regard to seizure control the patient was left at the same settings and no interventions are planned. No other information was available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2457661
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« Reply #3799 on: February 26, 2018, 02:19:14 AM »

Model Number 302-20
Event Date 01/09/2012
Event Type Injury
Manufacturer Narrative

Event Description
The patient called and was crying and upset. Frustrated that she cannot tolerate the increases to her device. She is depressed because she has not been able to return to her former level of functioning prior to her re-implant last year. The patient's treating physician is aware of the patient's issues tolerating their stimulation and an appointment was going to be made for the patient to be seen for evaluation.

Event Description
On (b)(6) 2012, a vns treating neurologist reported to the manufacturer's consultant that the vns patient was experiencing a 'tightness" in her neck and that over the weekend the patient's range of motion decreased and she could only turn her head about 10% in either direction. There is no pain with stimulation and the range of motion is independent of stimulation. Over the weekend, the patient also experienced a seizure and went to the emergency room. It took the patient a few days to recover. It was reported that the patient does not take her medications on a regular basis and she has a stressful lifestyle. On the friday before the weekend, (b)(6) 2012, the physician increased the patient's settings from an output of 1. 5ma to 1. 75ma. The patient remained in the office for 10-15 minutes following the programming change and reported that she was tolerating the increase. The patient was also observed on friday for her report that she had a clicking noise in her throat, however, no clicking occurred during the clinical visit and it lasted for 45 minutes. The patient reported that she had experienced two episodes of clicking in the front of her throat during stimulation. She stated that the clicking lasted for 30-60 seconds and the episodes were two weeks apart. There was no discomfort associated with this. The patient stated that the previous weekend, she also had a breakthrough seizure on (b)(6) 2012. The patient self-medicated with dilantin which elevated her dilantin level. Previously it had been six weeks since she had a seizure. The patient further stated that her husband is not using the recommended magnet swipe technique for her seizures. The husband was reported to be holding the magnet over the chest during the entire seizure, which disables stimulation, and then moved it away when the seizure stops. This then results in an uncomfortable strong stimulation after the seizure. Additional information has been requested but no further information has been received from the physician to date.

Event Description
Further reports regarding this patient's increased seizures with the suspect generator were received and all further relevant information regarding this event will be captured mfr. Report # 1644487-2017-03470.

Event Description
Additional information was received on (b)(6) 2012 when the patient stated that her throat hurt with stimulation the night before but not as much in this morning. The patient said the magnet swipes help with seizures, but sometimes her husband swipes the magnet when she is coming out of a seizure and she can't tell him not to, and then it hurts. The patient was seen by the neurologist on (b)(6) 2012 and the vns device was interrogated and system diagnostics were performed which showed results within normal limits; lead impedance=ok/dcdc=2. The patient's generator was programmed to output=1. 5ma/frequency=30hz/pulse width=250usec/on time=7sec/off time=0. 3min/magnet output=2ma/magnet on time=60sec/magnet pulse width=250usec. During the final interrogation, the patient appeared to have an absence seizure then coughed and said she was having pain at the generator site. During the seizure, the magnet had been swiped. The generator was then programmed off, both in normal and magnet mode. The neurologist stated that he is going to leave the generator off until a 3 day video eeg can be done. On (b)(6) 2012, the patient reported that she is 2 days into the ambulatory monitoring and says she has had nocturnal seizures and migraines while monitored, but these are better tolerated without vns; she stated that vns gives her after effects like pain. The patient said she has discomfort above the generator randomly for 20-30 minutes at a time which is the same as before vns was turned off. The patient was seen for a follow-up visit on (b)(6) 2012 and the physician stated that he believes the patient's pain and "tightness" or limited range of movement, are psychiatric in nature and not related to vns. The physician turned the patient's device back on and the patient will not be seen again for another month.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2461478
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« Reply #3800 on: February 26, 2018, 02:19:58 AM »

Model Number 102
Event Date 03/31/2009
Event Type Injury
Event Description
It was reported through clinic notes received on (b)(6) 2012 that the patient experienced seizures "all day wednesday" in notes dated (b)(6) 2009. The patient also reported having two grand mal seizures in notes dated (b)(6) 2009 for which an ambulance was called. On both dates, (b)(6) 2009 and (b)(6) 2009, the patient's settings were adjusted. Diagnostics from (b)(6) 2009 were within normal limits. Attempts to the patient's neurologist have been unsuccessful as the site has no additional information on these events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2464913
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« Reply #3801 on: February 26, 2018, 02:20:55 AM »

Model Number 102
Event Date 09/27/2011
Event Type Injury
Manufacturer Narrative

Event Description
It was reported via clinic notes received that the patient was experiencing an increase in seizures and was experiencing "at least one seizure a week. " the patient's vns is noted as being at end of service; however, it is unknown if the increase in seizures is believed to be related to this. A battery life calculation was performed that confirmed that the generator was likely at, near, or past end of service. The physician has increased the patient's vns settings and has referred the patient for generator replacement. Surgery to replace the patient's generator is likely. Attempts for additional information have been unsuccessful to date.

Event Description
Additional information was received indicating that the patient would not be undergoing battery replacement as the patient and his family felt that the vns had not helped his seizure control and the patient did not wish to undergo surgery. The patient was noted as only having one seizure in a month's time per the patient's family. Follow-up with the neurologist's office found that the patient's seizures are believed to be related to the generator end of service. The patient's generator was able to be interrogated on (b)(6) 2012, at which time the "elective replacement indicator" (eri) was "yes" indicating it was time for the generator to be replaced. Otherwise, the diagnostics taken on that date showed normal device function as per the site however specifics were not available upon request. The generator could not be interrogated on (b)(6) 2012, due to end of service. When the patient had been previously seen on (b)(6) 2011, the eri flag was "no. " the relationship of the increased seizure frequency to the pre-vns baseline seizure frequency is unknown. No medication or programming changes were believed to have caused or contributed to the increased seizures. The patient's neurologist is encouraging the patient to pursue replacement however it appears that the patient does not wish to have it replaced at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2465932
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« Reply #3802 on: February 26, 2018, 02:21:51 AM »

Model Number 102
Event Date 10/04/2010
Event Type Injury
Event Description
It was reported via clinic notes dated (b)(6) 2011 and received on 01/20/2012 that a vns patient experienced an increase in seizures since his last visit on (b)(6) 2010. The patient was restarted on clonazepam on (b)(6) 2011 and since that time, the seizures are shorted in duration lasting 2 minutes versus five minutes but are occurring more frequently. On average, the patient has two tonic seizures daily with stiffening of his entire body. The patient continues to have daily myoclonic seizures that occur as single events throughout the day that are brief and said to not be interfering with the patient's quality of life. The vns device was said to be functioning properly so other treatment options were discussed. The patient is not a candidate for resective surgery as he has generalized seizures. Good faith attempts to obtain additional information have been unsuccessful to date.

Event Description
Additional information was received from the patient's nurse practitioner on 02/16/2012. She stated that the increase in seizures is due to a decrease in the patient's dosage of clonazepam. The patient was re-started on clonazepam. The seizures were below pre-vns baseline levels.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2455789
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« Reply #3803 on: February 27, 2018, 02:49:21 AM »

Model Number 102
Event Date 10/24/2011
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2011 reported that the pt had clusters of seizures the two weeks prior, which was noted to be an increase in seizures. The physician felt that the seizures may be more frequent because the generator needed to be replaced. The pt's caregiver reported that the pt had more than 20 seizures. He received rectal diastat to terminate the seizures. Ems gave him iv ativan, and the seizures stopped. It was also noted that the pt was recently diagnosed with angioedema. The caregiver wondered whether the increase in seizures could have been related to angioedema. The physician suggested to keep the medications the same, but to increase if he experiences a cluster of seizures. In notes dated (b)(6) 2011, it was noted that the pt was hospitalized six weeks prior in (b)(6) 2011, but he had not had any seizures since the hospitalization. Follow up with the physician's office revealed that the pt's caregiver took the pt to the er due to a very bad seizure in (b)(6) 2011, as previously reported in mfr report number: 1644487-2011-02940. The pt had generator replacement surgery on (b)(6) 2011. The implant card was received and indicated the reason for replacement due to battery depletion with near end of service=yes. The generator was received by the mfr. The product analysis was completed and approved on (b)(6) 2012. No anomalies were noted during the analysis. The reported end of service was not duplicated. However, the elective replacement indicator (eri) was set. The battery was partially depleted and determined to be the result of normal expected battery consumption. There were no performance or any other type of adverse conditions found with the pulse generator. Since the generator was found to not be at end of service, attempts for add'l info concerning the pt' increased seizures have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2459570
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dennis100
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« Reply #3804 on: February 28, 2018, 02:25:02 AM »

Event Date 01/16/2003
Event Type  Malfunction   
Event Description
It was reported in a scientific article that a vns pt experienced an increase in seizures, due to unk reason as the cause of epilepsy and seizure type was variable. Good faith attempts to obtain additional info have been unsuccessful to date.
 
Manufacturer Narrative
Article citation: murphy, jerome v. , richard torkelson, irene dowler, and stephen simon. "vagal nerve stimulation in refractory epilepsy. " arch pediatr adolesc med 157 (2003): 560-64. Print.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1587433
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« Reply #3805 on: March 01, 2018, 04:24:23 AM »

Model Number 102
Event Date 10/29/2010
Event Type Injury
Event Description
Reported indicated a vns patient was having increased seizures, and that the vns was not at end of service. The patient is currently having testing to determine the etiology of the seizure increase. The vns is working properly per the reporter. The level of the seizure increase relative to the pre-vns seizure baseline level is unk. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1910684
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« Reply #3806 on: March 02, 2018, 01:58:56 AM »

Model Number 102
Event Date 03/26/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient felt like there may be an issue with her vns device as she had a seizure that lasted for five minutes however they usually only last for 30 seconds or 1. 5 minutes at the most. The diagnostics were said to be okay however the specific test results were not provided. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2538213
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dennis100
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« Reply #3807 on: March 02, 2018, 01:59:57 AM »

Model Number 102
Event Date 12/15/2011
Event Type Injury
Event Description
A fax was received from the physician's office on (b)(6) 2012, with additional information. The patient began to experience an increase in seizures in (b)(6) 2011. No causal or contributory programming or medication changes preceded the onset of the increased seizures. Vns revision was performed as an intervention for the increased seizures. No patient manipulation or trauma occurred that is believed to have caused/contributed to the increased seizures. The patient is not having more seizures than she was prior to being implanted with vns. The relation of the increased seizures to vns is unknown.

Event Description
Additional information was received on (b)(6), 2012 from the surgeon's office reporting that the patient only underwent generator replacement. The lead was reported to be in excellent condition and did not need to be replaced. Operative notes dated (b)(4) 2012 were also received on (b)(4) 2012 with the patient's post-operation settings.

Event Description
It was reported that this patient had an increase in seizures. The patient was also hospitalized for a seizure on (b)(6) 2011. The patient underwent prophylactic generator replacement on (b)(6) 2012. Attempts for product return will be made. Attempts to obtain any additional information have been unsuccessful to date.

Manufacturer Narrative

Event Description
Additional information was received that the patient's explanted devices could not be returned for product analysis without patient consent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2543592
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« Reply #3808 on: March 03, 2018, 02:55:33 AM »

Model Number 102
Event Date 02/01/2011
Event Type Injury
Event Description
It was reported via clinic notes received dated (b)(4) 2011 that the vns patient had been experiencing multiple seizures that "calmed down" after the zonegran dosage had been increased. The patient was not noted as having increased seizures on the previous clinic note dated (b)(6) 2010. Diagnostics taken on a later date were within normal limits. Attempts for further information have been unsuccessful to date.

Manufacturer Narrative

Event Description
Additional information was received from the physician indicating the increased seizures are not related to vns. The increased seizure frequency was noted as below the pre-vns baseline seizure frequency. No causal or contributory programming changes, medication changes, or other external factors were believed to have caused or contributed to the increased seizures. All of the patient's seizure types were noted as increased. The interventions previously noted were indicated as briefly improving the patient's seizures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2517447
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« Reply #3809 on: March 03, 2018, 02:56:31 AM »

Event Date 01/01/2006
Event Type Malfunction
Manufacturer Narrative

Event Description
On (b)(4), 2012 it was reported that the vns patient was initially implanted with vns in the (b)(4) 2002 and began to feel ill with significantly more seizures and absence seizures in 2006. The patient's condition also worsened and he began to cough often and long and coughed until he threw up. The patient was reported to have seen the neurologist on several occasions. In (b)(4) 2009, the patient visited the dentist and the patient's teeth were ground and an ultrasound was performed. The patient 'jumped in the chest' and was hurt by the vns. It was noted that this was pain at the generator site. The patient had severe coughing, felt sick, and had trouble breathing when he left the dentist's office. When the patient came home, the patient's mother suspected that something was not right with the vns. When the settings of the vns could be adjusted by the hospital, the patient coughed hard and long, lost her breath, and turned blue in the face. It was reported that the physician had not been through something like this before. It was noted that this event occurred three times. In the (b)(4) 2010 it was reported that the manufacturer concluded that the vns was broken in the patient's body and the patient underwent revision surgery for a new vns to be implanted. It was reported that the explanted product had been previously been returned for product analysis however as the product information was not provided nor was additional patient identifying information, this could not be verified. Additional information has been requested from the physician but no further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2854670
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