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Author Topic: Increase/Worsening of Seizures  (Read 632803 times)
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dennis100
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« Reply #3960 on: August 11, 2018, 01:47:40 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported from the patient¿s mother that the patient was implanted in (b)(6) 2017 and in (b)(6) 2017 the device was titrated up to therapeutic levels and he began to have more seizures. She has continued to follow up with the neurologist and the device has been titrated up in response to the increased seizures. However, she suspected that vns was causing the increase in seizures so she taped the magnet over the device and his seizures stopped. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7695401
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« Reply #3961 on: August 12, 2018, 12:23:02 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/29/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Report received that within two weeks of a patient's generator replacement, she experienced an increase in seizures. The device was reportedly turned on in the or after surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7674953
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dennis100
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« Reply #3962 on: August 15, 2018, 03:42:36 AM »

Model Number 102R
Event Date 10/01/2012
Event Type  Malfunction   
Event Description
The treating physician's office reported that the patient suspects the battery has depleted, as she was recently experiencing an increase in seizures. The caregiver believes that the battery may need to be replaced. However, it was noted that the near end of service flag is not triggered. The physician requested a battery life calculation be performed. There has been no indication to date that any intervention has been taken or planned. Attempts for additional information from the physician's office have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2809962
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dennis100
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« Reply #3963 on: August 17, 2018, 06:41:08 AM »

Event Date 12/31/2010
Event Type  Injury   
Event Description
On (b)(6) 2011, the vns pt's mother reported to the manufacturer's case mgr that the pt had developed a gastrointestinal virus and sinus infection at the end of (b)(6) 2010. The physician prescribed an antibiotic, omnicept, and he then began to vomit on a daily basis after meals. He has lost weight (b)(6). His seizures have increased, but his mother says she's able to avert a seizure with the magnet. The physician interrogated the device in (b)(6) 2011 and the device was working fine; the pt has not seen the physician since then. Since (b)(6), the pt's mother has taken child to a gastrointestinal specialist and he has had a full gastrointestinal workup and the final diagnosis was gastroparesis. The pt has had a gastric emptying test which shows slowing of emptying; he's had an upper gastro-intestinal which was negative, and a scan of abdomen which showed a questionable small gastric ulcer. The pt has had slight gastric reflux prior to this; however, from the original implant in 2007 till now, there have been no problems. The pt is still vomiting every day and the gastrointestinal specialist has told her that the only way to improve the nutrition was a feeding tube. He's often having seizures during the night. The pt's mother was told that if she's having that much issue with their child vomiting, to have the neurologist turn the device off so that he and she can see if there's a correlation between the stimulation and the vomiting, but the mother said that she doesn't want to turn it off as she still can control seizures with the magnet. Good faith attempts for more information were made to the physician and medical records but no additional information has been rec'd. If additional information is rec'd, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2093989
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dennis100
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« Reply #3964 on: August 19, 2018, 01:25:45 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported by the patient's father that the patient had present to the patient's neurologist three times in two weeks, but still continued to experience an increase in seizures. The patient's father denied any trauma or other issue that could have contributed to the increase in seizures. The patient's father reported that the neurologist checked the vns at the recent appointments and did not find anything wrong with the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6905400
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dennis100
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« Reply #3965 on: August 21, 2018, 08:49:59 AM »

Model Number 103
Event Date 03/01/2011
Event Type  Injury   
Event Description
It was reported that the pt was experiencing breakthrough seizures. F/u with the reporting physician found that he did not attribute the increase to anything in particular but rather just increased the pt's settings to combat the increase in seizures. No medication or programming changes were believed to have contributed to the increase in seizures. Vns diagnostics were okay as per the physician. The reporter is not the pt's normal neurologist therefore, it is unk how the pt's increase compares to pre-vns levels. F/u with the pt's normal neurologist found that they had not been informed of the increased seizures. No further issues have been reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2039472
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dennis100
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« Reply #3966 on: August 22, 2018, 07:07:21 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 decided to replace the generator. The dr was able to establish communication with the generator and the generator was not at end of svc. He also informed us that the pt had improved seizure control with vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1130843
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dennis100
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« Reply #3967 on: August 26, 2018, 02:04:20 AM »

Model Number 102
Event Date 11/28/2011
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Further information was received from the reporting physician indicating that she had no information on the lead model and serial number. The increase in seizures started in (b)(6), and passed from 1 seizure per day to multiple seizures per day. No further information was provided by the physician.
 
Event Description
It was reported by a neurosurgeon that a vns patient experienced an increase in seizures 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=2374988
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dennis100
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« Reply #3968 on: August 26, 2018, 02:05:18 AM »

Model Number 104
Event Date 12/01/2013
Event Type  Injury   
Event Description
Clinic notes were received indicating that the vns patient was admitted to the hospital in (b)(6) 2013 for seven days for recurrent seizures. During hospitalization, the patient had 120 seizures that all came from the right parietal lobe and quickly spread. The patient¿s medications were subsequently changed. The notes also indicate that during an office visit on (b)(6) 2014, the patient had a few brief myoclonic seizures that lasted approximately a minute long. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator and lead passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3764725
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dennis100
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« Reply #3969 on: August 30, 2018, 11:50:36 AM »

Model Number 102
Event Date 01/22/2006
Event Type  Injury   
Event Description
It was reported to manufacturer that the vns pt had experienced a worsening of the seizure disorder and the physician had attributed the worsening to nvs therapy. The physician had attempted multiple setting changes in an attempt to obtain efficacy with the device, however, they were unsuccessful. The device was subsequently disabled, and the patient's seizures are currently being controlled with a medication regimen. The pt had a surgical consult to have the device removed. Subsequently, surgery occurred where a portion of the lead and generator were removed and returned to manufacturer for analysis. Analysis is currently underway. Device diagnostics were performed at the explant surgery and revealed normal device function.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1329155
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dennis100
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« Reply #3970 on: September 03, 2018, 01:48:28 PM »

Model Number 102
Event Date 06/01/2011
Event Type  Injury   
Event Description
It was reported by a company rep that a vns pt experienced an increase in seizures due to unk reason. A blc was performed on the pt's generator and with the available programming history it was determined that the generator was at. 15 yrs until eri = yes. Further info from a company rep indicated that the pt was referred to prophylactics replacement due to the increase in seizures. The treating neurologist attributed the pt's increase in seizures to loss of therapy and elevation of dc dc code. F/u by a company revealed that the dc dc code was 4, which was a normal value. The info was communicated to the treating physician. Interventions planned were to replace the pt's generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2180952
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dennis100
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« Reply #3971 on: September 04, 2018, 08:41:51 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 #3972 on: September 04, 2018, 08:42:29 AM »

Model Number 103
Event Date 01/01/2008
Event Type  Injury   
Event Description
During a retrospective review of pt data at various european locations, it was noted that the pt's predominant seizures (tonic-clonic seizures) were noted as having an increase in frequency, as well as an increase in the duration of seizures, ictal severity and post-ictal severity of seizures at the 1-year and 2-year follow-ups. It was also indicated that the pt's other seizure types (partial seizures with secondary generalization, myoclonic seizures and atypical absence seizures) were increasing at the same visits. It was noted at the pt's most recent visit ((b)(6) 2010) that the device was disabled due to unk reasons. A search performed in the manufacturer's programming history database indicated that the last known diagnostics were within normal limits. Good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2236566
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dennis100
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« Reply #3973 on: September 05, 2018, 08:29:40 AM »

Model Number 103
Event Date 03/01/2009
Event Type  Malfunction   
Event Description
Reporter indicated a vns therapy patient is experiencing an increase in seizures. The patient's pre-vns seizure activity level is unknown. Diagnostics are all within normal limits and the generator is 4. 6 years until the elective replacement indicator will read "yes". No medication changes, patient manipulation, or trauma preceded the onset of the event. 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=1455247
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dennis100
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« Reply #3974 on: September 06, 2018, 01:55:56 AM »

Model Number 102
Event Date 05/02/2011
Event Type  Injury   
Event Description
It was reported via clinic notes dated (b)(6) 2011 that the pt "presents today for eval of still having seizures, no change, six in one month. " also notes pt has "partial epilepsy, w/impairment of consciousness, w/intractable epilepsy. Headache/facial pain. Cervicalgia. Abnormality of gait. Clinically, the condition is worsening. " the pt is being referred for a prophylactic generator change. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2229151
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dennis100
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« Reply #3975 on: September 06, 2018, 01:56:31 AM »

Model Number 102
Event Date 01/01/2009
Event Type  Injury   
Event Description
It was reported by a patient's caregiver that they wanted the device removed as it was not helping with seizure control. The patient's caregiver stated that when the patient uses the magnet for seizure control, it actually makes the seizures stronger. Good faith attempts to obtain additional information from the patient's neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1530573
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dennis100
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« Reply #3976 on: September 07, 2018, 11:32:33 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/14/2018
Event Type  Malfunction   
Event Description
It was reported that the patient had experienced an increase in seizures of 2 to 3 seizures per day for approximately two weeks from relative seizure freedom. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7765709
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dennis100
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« Reply #3977 on: September 07, 2018, 11:33:10 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/05/2017
Event Type  Injury   
Manufacturer Narrative
Event Description
It was reported by the patient that he has had more seizures. He clarified he is having fewer seizures than he did before the vns was implanted, but he is still concerned with the functionality of his current device. Per patient, the implanting surgeon "nicked his skin" during his implant surgery. Per surgeon, patient would be fine, but patient is concerned this may potentially be a cause of the increased seizures. Patient also stated he hasn't been able to feel the stimulation in his device since this implant, when he could feel stimulation on previous implants. Per neurologist's clinic notes, the patient said that he has had more auras and has to stimulate the vns more. Further, he said that the vns device has much pain and soreness around the area that he thinks that this is unusual. Patient also said that the injections in the inferior pectoralis major muscle/serratus posterior were not effective. Per the doctor, the patient still has tenderness and point pain around the vns device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7774387
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dennis100
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« Reply #3978 on: September 07, 2018, 11:33:43 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Event Description
It was reported that the patient's seizures had worsened following a change in settings. It was reported that the settings were changed due to the patient experiencing breathing problems since being implanted with vns. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7775634
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« Reply #3979 on: September 07, 2018, 11:34:18 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/12/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported by the patient's sister that the patient was experiencing an increase in seizures and pain at the vns generator site. It was later reported by the patient's sister that the patient was in the hospital due to an increase in seizures. The patient's pain was described as a "knife stabbing feeling" at the generator site. The patient also reported a headache. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7740744
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dennis100
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« Reply #3980 on: September 07, 2018, 11:34:52 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Event Description
It was reported via clinic notes received by the manufacturer that the patient had experienced an increase in seizures and had a lot of pain at the vns site. However, these notes reporting these adverse events were copied exactly throughout all of the clinic notes received and the date of the event could not be determined. The patient later underwent vns lead replacement surgery due to high impedance, which is captured in mfg. Report #1644487-2018-01055 and occurred after the events report in this mfg. Report. However, lead product analysis is not relevant to this file. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7784749
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« Reply #3981 on: September 07, 2018, 11:35:24 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/19/2018
Event Type  Injury   
Event Description
It was reported that the patient was in the emergency room due to increased seizures. The patient saw his neurologist last week, but his vns has not been checked in years. There was a concern that the device may be depleted. Additional information was received the battery showed ¾ remaining. It was noted that this is a special needs patient. He has increase in seizures when infections occur. But none present. The physician states it was part of his baseline however this is unclear as to whether the increase is at or below pre-vns baseline. The patient's settings were previously 1. 75ma and presumably decreased to 1. 5ma after his admittance to the hospital. It¿s only been one week, but he has returned to baseline. Impedance was stated to be normal. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7779246
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« Reply #3982 on: September 07, 2018, 11:35:57 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/26/2018
Event Type  Injury   
Manufacturer Narrative
Event Description
It was reported that a patient who was implanted with sentiva and had her scheduled dosing - standard protocol turn on the date of implant was seeing an increase in length and severity of her seizures with vns. It was stated that the patient's daytime, myoclonic seizures were responding very well to vns and had been completed eliminated with stimulation at 0. 5 ma. However, it was also reported that the patient's nighttime convulsive, tonic seizures had gotten worse. The device settings were kept at 0. 5 ma for the daytime, while the nighttime output current was programmed off, except for the magnet. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7788943
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« Reply #3983 on: September 07, 2018, 10:33:25 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2017
Event Type  Malfunction   
Event Description
The patient reported that they are having very frequent "black outs" but is unsure if they are seizures or not. The patient has indoor cameras and when reviewed , there is no outward appearance of seizures, but it was stated that they just appear to be dead on camera, and the patient's latest blackout lasted for several days. The patient recently had a fall during one of the blackouts. The patient stated that the vns has never helped her. Additional information was received from the patient's previous neurologist who stated that they have not seen the patient since 2014, and there was no mention previously of the patient's black out events. It was stated that there is mention in the notes that the patient's vns stimulation was increased in (b)(6) 2013. It was stated that they didn't have any additional information. The patient reported that they have not seen a neurologist in over 3 years, and is currently only seeing their pcp. The patient is experiencing an increase in seizures which was described as dropping back as though dead where the patient is unconscious. The patient stated that she recently went to the er in response to one of these seizures. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7792799
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« Reply #3984 on: September 07, 2018, 10:34:04 PM »

Model Number 100
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2002
Event Type  Injury   
Event Description
The patient's device was explanted in 2002. Information was received from the neurosurgeon that the vns did not improve the patient's seizures. According to the patient her epilepsy may have worsened. Both the generator and lead were explanted. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7797576
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« Reply #3985 on: September 07, 2018, 10:34:33 PM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/25/2018
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized due to an increase in seizures. It was reported that the patient's caregiver believed this may be due to a depleted battery. The patient was referred for generator replacement. An estimation of the remaining battery life from the available settings data did not support an end of service condition. No relevant surgical intervention is known to have 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=7794154
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« Reply #3986 on: September 07, 2018, 10:35:05 PM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/09/2018
Event Type  Injury   
Manufacturer Narrative
Event Description
It was reported that a patient was experiencing an increase in seizures. Prior to the increased seizures, the patient had experienced a drop seizure and his left chest near the vns was hit during his fall. The patient's device could not be interrogated by his community neurologist's programming system nor the programming system at the regional epilepsy center, so the epilepsy center physician suspected the patient's lead or generator may have been damaged during the drop seizure. No additional relevant information has been received to date. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7837267
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« Reply #3987 on: September 07, 2018, 10:36:00 PM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/25/2018
Event Type  Malfunction   
Manufacturer Narrative
Event Description
It was reported that the patient was implanted a little over three years prior with rapid cycling. The most recent interrogation of device was reported to be normal and the patient felt magnet stimulation. However, patient had more seizures the past several months, so the physician's assistant wanted to verify that the battery was not depleted. It was thought that the increase in seizures was due to stress and environmental problems but the vns device was not ruled out entirely. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7798909
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« Reply #3988 on: September 08, 2018, 01:11:32 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/06/2018
Event Type  Malfunction   
Event Description
It was reported by the patient's father that the patient had 2 seizures which were more intense than usual, but the paralysis did not last as long as usual. The patient's father was concerned about the intensity and already informed the neurologist. The patient was seen by their neurologist and the settings were ramped up at that time. Additional information was reported that this patient was admitted to the hospital due to increased seizures. Multiple attempts for relevant information were made, but no information has been received to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7806962
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« Reply #3989 on: September 09, 2018, 01:30:28 AM »

Model Number 102
Event Date 08/01/2010
Event Type  Injury   
Event Description
It was reported on (b)(6) 2012 that the patient had an appointment scheduled with a surgeon to discuss revision. The patient met with the surgeon on (b)(6) 2012 and the device was checked and said to be functioning properly. Surgery is not planned at this time.

Event Description
It was reported that the patient underwent generator replacement on (b)(6) 2013. Diagnostics with the new generator and existing lead were reported to be "ok". The patient was programmed on as requested by the treating neurologist and confirmed by the surgeon. An implant card was received which confirmed that the generator was replaced on (b)(6) 2013 due to prophylactic reasons. The lead impedance was marked "ok". It was reported that the generator was destroyed per hospital policy and will not be returned to manufacturer for analysis.

Event Description
It was reported on (b)(6) 2013 that the patient had been experiencing recurrent seizures due to the device being at end of service. They physician indicated that he has "tested" the device twice and that it needs replacement. It is unknown if there was an increase in seizures or if it was just a continuation from the event reported when the patient was finally seen by the physician. Further follow-up revealed that the patient was seen on (b)(6) 2013 at which time the device was reprogrammed and the settings were changed. After the change in settings the physician ordered the patient to activate magnet stimulation three times a day. It was reported that the patient reacts with a cough with magnet stimulation after the settings were changed. It was reported that the device was not at end of service and no malfunction is suspected. The device was able to be interrogated as settings were adjusted at this visit. It was reported that the patient was referred for prophylactic replacement. Surgery is likely, but has not occurred to date. Attempts to obtain additional information have been unsuccessful to date.

Event Description
Further follow-up revealed that the physician feels that the generator is nearing end of service and has recommended that the generator be replaced. The physician indicated that device settings were increased; however, no device diagnostics were performed. The physician reported that device diagnostics in (b)(6) 2012 were 'ok. ' the physician feels that the increase in seizures is related to the device nearing end of service. It was reported that the patient has been doing well since the adjustments in device settings and also having the patient activate magnet mode stimulation three times a day.

Manufacturer Narrative

Event Description
Follow up was performed with the neurologist who checked her device on (b)(6) 2012 and it was indicated that everything was ok. The patient continued to have an increase in seizures with two seizures over the previous two months. It was noted that between 2006-2011, she had only experienced one generalized tonic-clonic seizures and rare breakthrough complex partial seizures. It was indicated that the patient had increased one of her medications as well. On (b)(6) 2012, the patient's settings were increased and the physician has not heard from the patient since. No other information was obtained.

Manufacturer Narrative
Adverse event, corrected data: additional information was received indicating that medical interventions are being taken due to the reported event. This report is being submitted to correct this information. Outcomes, corrected data: additional information was received indicating that medical interventions are being taken due to the reported event. This report is being submitted to correct this information. Type of reportable event, corrected data: additional information was received indicating that medical interventions are being taken due to the reported event. This report is being submitted to correct this information.

Event Description
It was reported by the patient that she was experiencing an increase in her seizure activity and that she no longer feels stimulation when she swipes her magnet. The patient indicated that she feels the device might not be working. The patient's generator has not been checked in about four years and the patient has not yet followed up with a vns treating neurologist. Attempts for additional information have been unsuccessful to date.

Event Description
Additional information was received from the patient indicating that her recent increase in seizures was not above her pre-vns baseline. She reported that she has been experiencing an increase in seizure activity for about a year and that it may be related to the increased stress she has been experiencing over the past year. To-date the patient has not followed up with a vns treating neurologist to have her device checked.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2264295
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