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Author Topic: Increase/Worsening of Seizures  (Read 424154 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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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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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dennis100
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« Reply #3793 on: February 18, 2018, 02:54:56 AM »

Model Number 102
Event Date 11/01/2010
Event Type Injury
Event Description
It was initially reported that the pt was scheduled for a battery replacement surgery due to generator was thought to be at end of life. Pt was hospitalized due to status and vns could not be interrogated. Pt was taken into surgery; however, the surgeon was able to interrogate the device and the generator was not confirmed to be at end of service. Reason for increase in seizures is unk. Good faith attempts to obtain additional info have been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1936142
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dennis100
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« Reply #3794 on: Today at 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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