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Author Topic: Increase/Worsening of Seizures  (Read 834023 times)
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dennis100
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« Reply #4200 on: May 11, 2019, 12:06:17 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2018
Event Type  Malfunction   
Event Description
It was reported that a patient was experiencing an increase in seizures clusters since having her vns replaced. The patient used to have an average of 6 seizures/month but reportedly had 13 cluster seizures in the previous night alone. Magnet mode stimulation was attempted to help but did not do anything. It was also stated that autostimulation was programmed but did not work for the patient due to the patient's low heart rate. The patient had not been seen by the neurologist and would not be seeing the neurologist until (b)(6). The nurse stated she had labs run on the patient to determine a cause but nothing was found. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8519876
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dennis100
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« Reply #4201 on: May 11, 2019, 03:45:11 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/18/2019
Event Type  Injury   
Event Description
It was reported that a patient was in the hospital due to an increase in seizures. No programming history was available to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8509048
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dennis100
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« Reply #4202 on: May 11, 2019, 03:45:47 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/28/2019
Event Type  Injury   
Event Description
It was reported from clinic notes received that the patient was referred for generator replacement due to increase in seizures and upgrade to sentiva for autostimulation. No additional information has been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8565988
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dennis100
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« Reply #4203 on: May 11, 2019, 03:46:23 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/03/2019
Event Type  Malfunction   
Event Description
Patient presented with an increase in seizures. The patient's mother expressed concern that the increase was related to vns therapy. The patient's treating medical professional adjusted the patient's settings and noted that the patient may tape the magnet over the device to see if the event was related to vns therapy. Autostim output current was disabled. Further information was received that the patient's seizures had settled down. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8555981
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dennis100
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« Reply #4204 on: May 11, 2019, 03:47:06 AM »

Model Number 1000
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 had experienced an increase in seizure frequency, from "a few seizures here and there" to 10-12, following vns generator replacement. The patient's settings were increased due to patient not feeling stimulation, and possibly due to the patient's increase seizure frequency. The physician indicated the cause of the increased seizure frequency, despite the vns, was unknown and that the patient believed the frequency of seizures increased since the vns was turned on. No known external factors were identified that could have contributed to the increase in seizure frequency. The patient's generator did not appear to have been titrated up to therapeutic levels and the device was reportedly disabled. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8553129
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dennis100
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« Reply #4205 on: May 11, 2019, 03:47:44 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/03/2019
Event Type  Malfunction   
Event Description
It was reported that a patient stated vns therapy made his seizures worse. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8552554
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dennis100
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« Reply #4206 on: May 11, 2019, 03:48:31 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/28/2019
Event Type  Injury   
Event Description
It was reported that the patient was admitted to the hospital due to an increase in seizures and they wanted somebody to check the patient's vns. The physician reported that diagnostics were determined to be within normal limits. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8542294
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dennis100
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« Reply #4207 on: May 18, 2019, 01:22:13 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
It was reported by the surgeon's office to the company representative that the patient has experienced an increase in seizures due to battery depletion and she may have a vns generator replacement. It was unknown when the increase in seizures first began or if the seizures were below or above pre-vns baseline levels. A battery life calculation was performed using the information available within the programming history database. The battery life calculation showed the generator would have approximately 10 years remaining until reaching the neos = yes (near end of service) condition. It was later reported the company representative was able to check the patient's device while at the physician's office. The system diagnostics were ok with an impedance value of 2300 ohms, indicating the generator was working as intended. The physician's office reported they were unable to answer any additional questions due to lack of information from the patient. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported there was no vns generator replacement surgery planned or completed due to the increase in seizures. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6579846
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dennis100
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« Reply #4208 on: May 18, 2019, 01:25:37 AM »

Model Number 102
Event Date 12/12/2011
Event Type  Injury   
Event Description
The patient had their generator replaced and it is at the manufacturer pending completion of product analysis.
 
Event Description
Further information from physician indicates that the patient was having increased of cluster seizures which the patient has a history of. There is no clear provocateur for seizure clusters. The increase was similar to pre-vns levels and the physician feels they may be related to vns battery life decreasing even though eri = no. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the seizures. Depakote was increased to help seizures for now. Patient's mother reports compliance with medications. The patient was been referred for generator replacement, but it has not occurred to date.
 
Event Description
It was reported that the pt's seizures were up. Per physician, even though eri = no and system diagnostics were ok, the pt was being referred for generator replacement surgery. Surgery has not occurred to date.
 
Event Description
The pulse generator was returned due to a prophylactic replacement. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2419283
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dennis100
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« Reply #4209 on: May 23, 2019, 11:39:18 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported to a company representative that a patient experienced an increase in seizures and had gone to the emergency department. At the emergency department the vns was interrogated and the physician notes indicated no issues with system diagnostics. Additional relevant information has not been received to-date.
 
Event Description
Full revision occurred. Normal impedance was reported at surgery. The battery was not at end-of-service. It was provided the generator will not be returned. It was noted in surgery the lead was twisted however, high impedance was not found. The explanted lead was received by the manufacturer. Analysis is underway, but has not been completed to-date.
 
Manufacturer Narrative
Date of event, corrected data: it was inadvertently not provided in follow-up report #1 that the date of the event was clarified to be (b)(6) 2017.
 
Event Description
Follow-up from the physician¿s office provided the vns was causing shocks and the shocking was then causing seizures to occur. The mother then wanted the whole device replaced. She stated that after the replacement, all has been well. It was stated that the vns had reduced seizures since being implanted and although more seizures were occurring they were not worse than before. Analysis was completed for the returned lead. The coil appeared to be stretched, kinked, wavy and spiraled, in some areas. The returned connector pin coil appeared to be broken and during the incision process several broken coil strands were observed. Scanning electron microscopy was performed and identified the area as having evidence of a rotational stress induced fracture with secondary break lines and no pitting. Residual material was observed on the coil surface. The analysis supports that the breaks occurred as a result of the explant process due to the rotational type of fracture on the broken coil wire surfaces and secondary break lines. With the exception of the observed discontinuity the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The set screw marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6546464
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