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Author Topic: Increase/Worsening of Seizures  (Read 814156 times)
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dennis100
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« Reply #4080 on: January 04, 2019, 12:03:57 PM »

Model Number 102
Event Date 02/11/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient was experiencing an increase in seizures on (b)(6) 2014. The patient was re-implanted with a new generator on (b)(6) 2014 and did not have any seizures since the surgery until the day after the device was programmed on during an office visit on (b)(6) 2014. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3677819
« Last Edit: January 08, 2019, 09:13:16 PM by dennis100 » Logged
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« Reply #4081 on: January 04, 2019, 12:04:38 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/20/2018
Event Type  Injury   
Event Description
It was reported that the patient had an increase in seizures above their pre-vns baseline. No additional or relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Surgery is likely for the patient but has not occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8144024
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dennis100
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« Reply #4082 on: January 04, 2019, 12:05:11 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/05/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Initial report was that a patient was experiencing an increase in seizures. Attempts for further information have been unsuccessful. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8139459
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dennis100
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« Reply #4083 on: January 04, 2019, 12:05:53 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/19/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Patient's mother reported that the patient is experiencing an increase in seizures that started 7 days after the device was replaced. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8176696
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dennis100
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« Reply #4084 on: January 04, 2019, 12:06:37 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/08/2018
Event Type  Injury   
Event Description
It was reported that the patient was experiencing an increase in seizures, and that the only major change since the patient's replacement surgery was the autostimulation feature of the newer generator. The autostimulation feature was turned off to determine if this helped decrease the seizure frequency. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8126833
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dennis100
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« Reply #4085 on: January 04, 2019, 02:51:41 PM »

Model Number 1000
Event Date 10/18/2018
Event Type  Death   
Event Description
Reporter states her son had a slight seizure around 8 am and his heart stopped. The emt worked on him for several hours as his rhythm was stop and go. He was pronounced dead at 11am. A few weeks prior to this event, the pt had an mri done, in which his vns was turned off and the on again by a different neurologist. After the exam, the vns would constantly turn on and off on its own and started to affect his vocal cords. Her son mention he believed the neurologist may have turned the vns up too high and he wanted to have it explanted. She reports the device wasn't helping him and his seizures were getting worse, increasing to 6 violent episodes a month. She also notes her son was agitated and had horrible heartburn the day before he died which literally "knocked him forward. " the autopsy came back negative for any abnormal tests.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8155362
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dennis100
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« Reply #4086 on: January 05, 2019, 03:53:11 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/09/2018
Event Type  Malfunction   
Event Description
It was reported that the patient's increase in seizures had continued onto the new generator. Per the physician, they are still adjusting the patient's medications. The increase in seizures on the previous generator is reported under mfg report # 1644487-2018-02147. No additional or relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8151729
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dennis100
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« Reply #4087 on: January 05, 2019, 03:53:46 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/14/2017
Event Type  Injury   
Event Description
It was reported that a patient's device was replaced for an unknown reason. From follow-up on the reason, it was indicated that the replacement was due to " intensified follow-up indicator" and increased seizures. Review of the manufacturer's programming history database noted that the last diagnostics from the patient's device was recorded from the week before explant indicating that status checks were within normal limits. The explanted device was to be returned, however no device has been received to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8142864
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dennis100
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« Reply #4088 on: January 05, 2019, 03:54:47 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/18/2018
Event Type  Injury   
Event Description
Clinic notes were received for a patient's battery replacement referral due to "low" battery. It was stated in the notes that after vns settings were decreased for tolerability issues and the patient was weaned off medication (felbamate), the patient's seizures worsened substantially and the patient was vomiting without warning. It was also stated that the seizure clusters were lasting "twice as long as they used to be". Diagnostics indicated that the device was functioning within normal limits. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8141236
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« Reply #4089 on: January 05, 2019, 03:55:27 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/13/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that this patient was referred for a generator replacement due to battery depletion. Additional information was received from the neurologist stating that the patient is experiencing an increase in seizures (daily) and an urgent surgery referral was requested. The patient received a prophylactic generator replacement. The explant facility is historically a no return site, and per the or staff the site always discards in surgery. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8137423
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dennis100
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« Reply #4090 on: January 05, 2019, 03:56:04 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/13/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
Initial report from clinic notes was that a patient was experiencing an increase in seizures described as "little ones", brief staring, and eye deviations lasting 5 to 10 seconds and was referred for battery replacement. No known surgery 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=8139745
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dennis100
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« Reply #4091 on: January 05, 2019, 03:57:01 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/05/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported by the physician that the patient had an increase in seizures, increased notably in frequency and duration compared to the 4 months prior, starting the day after surgery. Prior to implant, seizure rate was 2-4 per month and after implant, it was 1 per day. The believed cause of the increased seizure frequency and intensity was device implantation and not device stimulation as it occurred the date after surgery. There was no believed external contributing factors. The device was off at the time of onset of seizures. Diagnostics were ok at the first visit after implantation. There was no medication change as a result of this event. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8123431
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dennis100
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« Reply #4092 on: January 06, 2019, 11:20:35 AM »

Model Number 103
Event Date 02/02/2015
Event Type  Malfunction   
Event Description
On (b)(6) 2015 it was reported that the patient has been experiencing an increase in seizures. Good faith attempts for further information from the physician have been unsuccessful to date.
 
Event Description
On (b)(6) 2015 the physician reported that this is not a patient of his. It is unknown at this time who the patient¿s neurologist is as this was the physician who was reported to be seeing the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4542324
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dennis100
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« Reply #4093 on: January 06, 2019, 11:23:14 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/20/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient reported experiencing an increase in seizures and painful stimulation. Further information was received that the patient is referred for replacement. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8150439
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dennis100
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« Reply #4094 on: January 07, 2019, 03:42:07 AM »

Model Number 102
Event Date 10/12/2012
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Clinic notes dated (b)(4) 2012, indicate that at the patient's last visit in (b)(6), she was having increasing myoclonic events as well as drop attacks. Additionally, her migraines were also worsening. The patient's vns was interrogated and was not near eos. The patient was considering discontinuing vns; however, the device was not disabled. Attempts are underway for additional information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3613393
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dennis100
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« Reply #4095 on: January 07, 2019, 03:42:46 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that this patient is experiencing an increase in seizures. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7046960
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dennis100
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« Reply #4096 on: January 08, 2019, 08:05:15 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/18/2008
Event Type  Malfunction   
Event Description
Clinic notes indicated that a patient's mother reported that her son had experienced an increase in seizures since his vns was initially implanted. The vns settings were increased at a subsequent clinic visit 1 month after implant. The patient's mother reported that the seizures increased after the settings adjustment. A review of programming history available over the implant life of the patient's device indicated that the device functioned properly. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7144714
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dennis100
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« Reply #4097 on: January 20, 2019, 03:48:04 AM »

Model Number 103
Event Date 02/18/2013
Event Type  Injury   
Event Description
It was reported that following generator and lead replacement surgery on (b)(6) 2013 due to high impedance, the vns patient experienced throat tightness and pain that did not occur with stimulation on-times. The patient was unable to tolerate the device settings that were programmed on the previous device. The patient reported that, since replacement, his face would sometimes swell. Diagnostic results showed normal device function. Follow-up revealed that physician attributed these issues to vns. The patient was given anti-inflammatory medications and his device settings were decreased. The physician also indicated that stress may have contributed to the events and that no medication changes preceded the onset of the events additional information was received stating that the patient also began experiencing numbness in the jaw and neck. The patient¿s seizures were noted to be more frequent and longer in duration. The physician attempted to increase the device settings but was unable to due to the patient¿s pain. The physician attributed the increase in seizure frequency and duration to the inability to increase device settings to therapeutic levels. Attempts for additional relevant information have been unsuccessful to date. The high impedance event was reported in manufacturer report #1644487-2013-00524.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4789910
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dennis100
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« Reply #4098 on: January 24, 2019, 05:17:08 AM »

Model Number 102R
Event Date 03/31/2004
Event Type  Injury   
Event Description
Additional information was received that the patient had a generator replacement. The generator will not be returned to the manufacturer as the hospital does not return explanted products to the manufacturer.
 
Manufacturer Narrative

Event Description
Initially, it was reported that the patient's family did not think vns therapy was working for the patient. The physician reported that lack of efficacy was never observed and feels that efficacy was present. Clinic notes dated (b)(6) 2013 note that the patient's family thinks the patient's seizures became worse with vns. The vns was programmed off and the seizure frequency has not improved. Attempts to obtain information as to whether or not the seizures increased with vns have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3907073
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« Reply #4099 on: February 01, 2019, 12:28:53 PM »

Event Date 01/01/2006
Event Type  Malfunction   
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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« Reply #4100 on: February 07, 2019, 09:33:00 PM »

Model Number 102
Event Date 06/01/2012
Event Type  Injury   
Event Description
It was reported that the patient's device was programmed off from (b)(6) 2012 because the patient felt seizures worse and didn't like the device. The patient was at 1. 5ma when the device was programmed off. It was reported that the device was programmed back on october 2012 at 0. 5ma and no changes have been made since that time and the family "likes" the settings where they are currently. It was reported that the patient is currently doing well and no additional information will be provided. It is unknown if the worsening of seizures was above the patient's pre-vns baseline.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3497444
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« Reply #4101 on: February 08, 2019, 01:27:12 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
The patient's parent reported via social media that vns didn't help that much for patient's seizures. They mentioned that when the vns was turned up to the average setting, it actually made the patient's seizures worse. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8291345
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« Reply #4102 on: February 08, 2019, 01:28:04 AM »

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

Event Description
It was reported by a patient's mother through a social media post that she was disappointed in vns as she hoped it would help more with seizure control. It was noted that the patient had recently been having more seizures. The patient's last "real bad" seizure occurred on her (b)(6) birthday in intensive care at the hospital. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8285462
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« Reply #4103 on: February 08, 2019, 01:28:48 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/18/2018
Event Type  Injury   
Event Description
It was reported that the patient was having an increase in seizures and increase in seizure intensity possibly due to a low battery. Patient was referred for a battery replacement. No additional relevant information has been received to date. No surgical intervention is known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8243759
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« Reply #4104 on: February 08, 2019, 01:29:44 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/04/2019
Event Type  Injury   
Event Description
It was reported by the patient's mother on facebook that her daughter is on more medication since starting vns a year ago. Her daughter is on eight meds and is seizing hundreds of times a day. This was determined to be an increase in seizures as the patient needed more medication to control their seizures. No patient could be identified by the reporter¿s last name. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8262717
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« Reply #4105 on: February 09, 2019, 04:14:13 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was having recurring seizure activity. The er attempted to interrogate the vns generator several times but was unsuccessful. Previous information in clinic notes received by the manufacturer indicated that the patient¿s generator was at end of service. The increase in seizures was attributed to a loss of vns therapy due to the battery depletion. The patient underwent vns generator replacement surgery due to the suspected battery depletion. The explanted generator was received by the manufacturer and product analysis was completed. The reported ¿end of service¿ allegation was not confirmed in the pa lab, although the elective replacement indicator flag was set. An open can measurement of the battery voltage confirmed that the eri flag had been properly set; the battery was ¿partially depleted¿. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion. The reported ¿failure to program¿ allegation was not duplicated in the pa lab. In the pa lab, the device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. There were no performance or other adverse conditions found with the generator. Follow up with the physician's office revealed that the increase in seizures occurred around when the office was unable to interrogate the patient's vns, which lead them to believe it was fully depleted. They were unable to provide an assessment on the comparison of the increase in seizures to the pre-vns baseline or its relation to vns. The last interrogation of the vns was approximately half a year prior and it was stated that the settings were stable and no changes were made to the programmed settings. It was indicated that diagnostics at the time indicated that the vns was "not as end of service". No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8241996
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« Reply #4106 on: February 09, 2019, 04:14:55 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/18/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was hospitalized due to an increase in breakthrough seizures. The vns was checked at this time and diagnostics results were within normal limits. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8236858
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« Reply #4107 on: February 09, 2019, 04:15:27 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/02/2018
Event Type  Injury   
Event Description
Clinic notes received as part of the referral process for generator replacement noted that the patient's family has noticed an increased number of staring type spells (which have been consistent with the patient's partial complex seizures in the past), and that the patient felt that their vns might not be working as well. However, the device is noted to be at 18-25% battery status and lead impedance/output current are registering as ok. The physician confirmed that patient began experiencing increased seizures about 1-2 months prior to the office visit recorded in clinic notes, and that the patient's seizures are above pre-vns levels. The physician does not know the reason for increased seizures. No known surgical intervention has occurred and no other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8292733
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« Reply #4108 on: February 09, 2019, 04:16:15 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/24/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes were received as part of the referral process for a prophylactic generator replacement. Within clinic notes, in regards to previous generator replacement procedure, it states that the patient experienced an increase in seizures and required vns battery replacement. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8284448
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« Reply #4109 on: February 09, 2019, 04:17:05 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/21/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing an increase in seizures. It was reported that replacement surgery would be pursued if the device's battery was found to be low. Multiple attempts were performed for additional information but remain unsuccessful to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8250898
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