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Author Topic: Increase/Worsening of Seizures  (Read 856697 times)
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dennis100
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« Reply #4230 on: June 11, 2019, 01:28:05 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/26/2018
Event Type  Injury   
Event Description
It was reported that the patient experienced an increase in seizure frequency and was referred for generator replacement surgery. The company representative reported that the patient's settings were high, in reference to their referral for generator replacement. The patient's implant card indicated that the generator replacement was prophylactic. Prior to the replacement surgery the patient's lead impedance was within normal limits. The suspect product has not been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8177102
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dennis100
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« Reply #4231 on: June 13, 2019, 03:45:27 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2017
Event Type  Injury   
Event Description
Report received that a patient presented with an increase in seizures in the clinic. During the same visit, it was reported that the patient did not feel magnet mode stimulation and the magnet no longer affected her seizures. The generator was also unable to be interrogated by the physician's programmer. This combination of events reportedly led the physician to believe the device had reached end of service and resulted in the referral for generator replacement surgery. At the patient's previous appointment about 6 months before, there was no indication the generator's battery was depleting. The vns settings were also provided from the interrogation performed during that appointment. The patient not feeling her magnet was also reported to have occurred during this previous appointment. System diagnostic results and pre-vns frequency levels were not provided. The physician's programmer was reportedly able to interrogate other generators after having a failure on this patient's generator. No surgical intervention has occurred to date. No further relevant information has been provided to date.
 
Event Description
Further information was received that the patient's generator was replaced. The generator has not been received by the manufacturer to date. No further relevant information has been obtained.
 
Event Description
Further information was received that the generator had been received for product analysis by the manufacturer. This analysis was later completed. Visual inspection did not identify any surface anomalies outside of the typical markings associated with implant and explant procedure. The device was able to be interrogated and system diagnostic testing was successfully performed. All results were normal. A test using magnet activation and disablement found that the reed switch was operating as expected. The generator was also tested in a simulated bodily environment and no changes or variations in output current were identified. A comprehensive automated electrical evaluation also showed that the pulse generator performed according to functional specifications. The data from the generator also did not show any anomalies. Proper functionality of the generator in its ability to provide appropriate programmed output currents was verified in product analysis. Updated programming data was also reviewed. The only available data was from the day of explant but it showed that the impedance was within normal limits. The battery status was also found to be functional. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7077230
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dennis100
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« Reply #4232 on: June 14, 2019, 06:26:28 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/29/2019
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported through clinic notes that the patient's vns battery status was 11-25% remaining,, so he needed to have a generator replacement soon. It was then indicated that the surgeon would need to be notified as the patient's seizures were increased. It was then reported that the increased seizures was how the mother knew that the battery was low. It should be noted that the patient's generator is designed to provide it's intended therapy until it's fully depleted, at which point the generator disables itself. High impedance was not reported. 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=8659874
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dennis100
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« Reply #4233 on: June 14, 2019, 06:28:26 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2017
Event Type  Injury   
Event Description
Report received through clinic notes that a patient presented with an increase in seizures. The patient's seizures increased from 10 days of seizures per month to 15 seizures per month over a span of about six months. The patient's generator was interrogated in the clinic and the settings were provided. It was stated that the generator was at end of service but the physician also indicated that battery life still remained. A review of the programming history only provided data from the day of implant, but showed diagnostics were normal at the time. The patient's generator was replaced and the generator was returned to the manufacturer. Product analysis has not been completed to date. No further relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the generator. Besides normal markings and discoloration seen with the implant and explant procedure, no visual anomalies were seen. The generator was interrogated and system diagnostics were run. All results were normal. The generator output was monitored in a simulated body environment and did not show any variation in expected output current. The generator also passed all electrical tests and performed according to all specifications. The battery voltage was measured and indicated the generator had been able to provide stimulation prior to explant. The data from the generator was also reviewed and did not show any anomalies. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7047049
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dennis100
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« Reply #4234 on: June 19, 2019, 04:32:24 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2995513
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dennis100
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« Reply #4235 on: June 26, 2019, 07:37:05 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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dennis100
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« Reply #4236 on: June 27, 2019, 12:25:05 PM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
The patient reported via (b)(6) that the vns device did not help them at all and made them worse. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7343702
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dennis100
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« Reply #4237 on: June 27, 2019, 12:26:17 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported by the patient that she has had an increase in seizures over the past month. She was concerned that her battery was depleted and was looking for a neurologist to check her device as it hasn't been checked in two years. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient was seen by a physician. The device was checked and found to still have some battery life remaining. Information was received from the physician's office that the patient settings were increased due to the increase in seizures. The changes in settings were well tolerated per the physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7340863
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dennis100
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« Reply #4238 on: June 28, 2019, 11:28:32 PM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/26/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Patient reported that he has been experiencing an increase in seizures since his generator replacement surgery. The neurologist could not provide any additional relevant information as they were not informed by patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7474529
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dennis100
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« Reply #4239 on: July 01, 2019, 10:51:45 AM »

Model Number 104
Event Date 01/27/2012
Event Type  Injury   
Event Description
It was reported by a physician that a vns patient experienced an increase in seizures due to unknown reason 40 days after a change in settings. Interventions take by the physician were to adjust the parameters on the patient due to the increase in seizures. At the moment it is unknown if the change in settings is correlated to the increase in seizures as good faith attempts to obtain further information have been unsuccessful to date.
 
Event Description
Additional information was received from the treating physician indicating the unpleasant stimulation was solved by lowering the settings. The worsening in focal seizures was likely attributed to the lowering of settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2495757
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dennis100
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« Reply #4240 on: July 02, 2019, 01:28:30 AM »

Model Number 102
Event Date 04/12/2012
Event Type  Injury   
Event Description
It was reported by a patient's mother, the patient was experiencing an increase in seizures due to unknown reason. Additional information was received from the patient's treating nurse indicating the patient not been seen lately and the reported increase in seizures was of unknown relationship to pre-vns level. The nurse did not know the cause of the increase in seizures and indicated it can be assumed the battery was running low. The last time patient was seen the end of service flag was not set. At the moment, replacement surgery is likely, but has not been confirmed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2559918
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dennis100
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« Reply #4241 on: July 02, 2019, 01:29:11 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/16/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient felt that her seizures had progressed. She was having 15 seizures daily that lasted between 10-15 minutes at a time. The device battery was found to be depleted. A battery life calculation was performed, which estimated 1. 7 years remaining battery life. However, the settings were from over two years prior. The patient had generator replacement surgery due to battery depletion. The generator has not been received to date.
 
Manufacturer Narrative

Event Description
The explanted device was received. Analysis was completed for the returned generator. The device output signal was monitored for more than 24 hours, while the pulse 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. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery was not depleted. 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=7594943
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dennis100
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« Reply #4242 on: July 02, 2019, 01:30:13 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a patient was to be referred for replacement surgery as the patient has had 3 seizures in the last month. No surgery has occurred to date. No further relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem. Corrected data. Initial mdr inadvertently missed including the programming history review.
 
Event Description
Programming history was reviewed for the device. Diagnostic information was available showing that the battery was functioning as intended, with ok battery status and ok impedance. Follow-up information was received from the physician stating that seizure levels were above pre-vns baseline levels and that the suspected cause of the increase in seizures was due to a need for a battery change, although it was not clear if this was due to a suspected malfunction or low battery. Settings and diagnostics were provided, showing the same information observed through review of the programming history database. No surgery has occurred to date. No further relevant information has been received to date.
 
Event Description
A battery life calculation was performed with the programming data available to the manufacturers. The results of the calculation indicated that it was unlikely that the device was nearing end of service; therefore, battery depletion was likely not the cause of the increased seizures. No additional relevant information was received to date.
 
Event Description
The patient underwent a successful prophylactic generator replacement. It was noted that the hospital discards all explanted devices so no explanted device is expected for return for analysis. No further additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7651118
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dennis100
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« Reply #4243 on: July 04, 2019, 01:23:27 AM »

Model Number 102
Device Problem Insufficient Information
Event Date 01/24/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported to a company representative that the patient had fallen from a seizure a few weeks ago. Diagnostics were reported to be ok. The patient reports an increase in seizures. The patient was referred for exploration/revision surgery, however no surgery has been planned or known to have occurred to-date. Follow-up from the company representative provided that the physician does believe the device is malfunctioning likely due to the fall the patient had, and that there was an increase in seizures. The increase in seizures is not worse than before vns, and was not caused by vns. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7560796
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dennis100
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« Reply #4244 on: July 04, 2019, 01:24:11 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/08/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Vns was discussed with a patient who was wondering how long a generator lasts before needing replacement. In discussing the signs of low battery, the patient noted that he has experienced some increased seizure activity. The patient was encouraged to check with his physician to determine when the vns was last checked. A battery life calculation was performed on the device, and did not confirm battery depletion with the programming history available. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7651865
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dennis100
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« Reply #4245 on: July 05, 2019, 11:53:36 PM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/07/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
The patient's neurologist reported that the patient's seizures had worsened and the patient experienced chest tightness / pain. It was reported that the vns stimulation was the cause of the adverse events and that there were no known external factors contributing to the patient's reported adverse events. It was reported that the patient was unable to tolerate the vns stimulation which led to the device output currents being disabled. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8695977
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dennis100
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« Reply #4246 on: July 05, 2019, 11:54:08 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported through clinic notes that during the visit the patient complained of possible vns malfunction and stated that she felt that she has increasing seizures in the last few weeks. The physician noted that her battery needed to be changed as it was nearing end of life. The manufacturer's battery life calculation with available data did not support low battery. 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=8745382
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« Reply #4247 on: July 05, 2019, 11:54:55 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the epileptologist stated that he thinks some patient's seizures worsen with autostimulation. It was also stated that the physician did not specify any cases that were mentioned in the original report. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8679068
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dennis100
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« Reply #4248 on: July 05, 2019, 11:55:46 PM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/13/2019
Event Type  Injury   
Manufacturer Narrative

Event Description
A report was received that the patient was admitted into the er due to an increase in seizures. It was stated that the physician had called the representative to confirm the device settings were correct after the patient's generator replacement surgery. An implant form was received indicated the patient's system diagnostics were within normal limits at the time of the replacement. Further information was received stating that the on call provider was the one who informed the representative that the patient was in the hospital for more seizures, and wanted to ensure patients device was turned back on after surgery, and representative confirmed it was. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8678268
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« Reply #4249 on: July 05, 2019, 11:56:25 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/03/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Patient experienced an increase in seizures after coming out of oral surgery. It was noted that the seizures caused the patient to stay in the hospital for 4 days. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8737842
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« Reply #4250 on: July 05, 2019, 11:57:10 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/04/2019
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Patient reported experiencing an increase in seizures and felt she needed a battery 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=8739367
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dennis100
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« Reply #4251 on: July 05, 2019, 11:58:01 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/04/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that a patient has had an increase in seizures and is hospitalized. It was originally reported because the patient's sister needed information to be provided to the mri department for a brain mri. Further follow up for additional information from the physician has been made and no information regarding the physician's assessment of the increase in seizures has been received to date. Information was received that the patient uses recreational drugs. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8740121
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« Reply #4252 on: July 05, 2019, 11:59:01 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/02/2019
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes received for the patient indicated that there were no issues with the device but the physician speculates that there might be a device issue as the patient is having an increase in seizures. The patient was referred for generator replacement. Further information was received that the physician had no assessment of the cause of the increase in seizures and that the patient was referred for replacement as the physician felt the newest device features would be better suited for the patient. Further information was received that the physician did not have an assessment of pre-vns seizure baseline levels. 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=8739345
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« Reply #4253 on: July 05, 2019, 11:59:38 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/04/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient presented with an increase in seizures. The patient's medications were adjusted and the facility requested the patient's vns be checked. It was reported that the seizures were related to the patient's underlying seizure disorder and there was no medical cause of the seizures. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8730907
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« Reply #4254 on: July 11, 2019, 02:37:29 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Report received that a patient had experienced left chest pain. Since the pain began, the patient also experienced 7 seizures which was reportedly more than he typically experienced. It was not known if this was above pre-vns seizure frequency. The patient reported these symptoms to his implanting surgeon who was able to check the functionality of the vns system and found that it was operating as expected. The manufacturer representative was also present at this time he reportedly swiped the magnet to a activate magnet mode stimulation and the patient did not report feeling any pain at that time. Blood-work and x-rays were taken to rule out other causes of the issues. The patient reportedly did not recall any event that would have caused strain or trauma to the left shoulder/chest area. The surgeon reportedly did not believe the pain had anything to do with the vns, but the patient was to follow-up with his neurologist. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7705975
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« Reply #4255 on: July 11, 2019, 02:38:18 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/15/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported through clinic notes that the patient was having an increase in seizure frequency. The parents were concerned that the vns battery was failing. 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=8706049
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« Reply #4256 on: July 11, 2019, 02:39:53 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2017
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinical notes were received as part of the referral process for vns generator replacement. The notes stated that the patient's seizure activity had increased. The patient's neurologist believed this to be due to the device's battery being depleted and stated that the increase was above pre-vns seizure activity. Diagnostics were reported to be normal, but the specific results are not known at this time nor the exact status of the battery when the increased seizure activity began. The patient's generator was replaced. The generator will not be received for analysis as the explanting facility historically does not return explanted devices. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7664143
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« Reply #4257 on: July 14, 2019, 04:54:16 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported by the patient that his seizures were changing. The patient was unsure if the seizures have improved since vns implantation. The patient stated that the magnet did not stop a seizure the previous week, but then he went on to have a large seizure that same day. The patient reported a possible increase in overall seizure count. Follow up with the physician's office revealed that the events had not been reported to the office. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7838241
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« Reply #4258 on: Today at 12:01:03 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported by the physician that the patient was seen with daily increased events. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7876471
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