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Author Topic: Increase/Worsening of Seizures  (Read 356519 times)
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dennis100
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« Reply #3600 on: November 22, 2017, 04:05:03 AM »

Model Number 102
Event Date 07/22/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the vns patient was experiencing an increase in seizures which the physician attributed to the depleting battery life of the device. The patient's device was tested during an office visit on (b)(6) 2015 and showed normal device function and battery status. The patient was referred for surgery but no known surgical interventions have occurred to date. Clinic notes were received for the patient's office visit on (b)(6) 2015 indicating that the patient was experiencing 1-2 seizures per month. Prior to vns, the patient had 4-5 seizures per day for three consecutive days and then may not have his next seizure until a few weeks later. Follow-up revealed that the patient had seven seizures that were believed to be above the patient's pre-vns baseline levels. The patient was initially experience an increase in seizures in the mornings so the patient's medications were adjusted; however, the patient began experiencing an increase in seizures in the evenings. No further information regarding the event has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4946672
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dennis100
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« Reply #3601 on: November 22, 2017, 04:05:57 AM »

Model Number 103
Device Problem No Information
Event Date 06/01/2015
Event Type Malfunction
Event Description
It was reported that the vns patient had been experiencing an increase in seizures for the past few weeks and may have developed a new seizure type. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Review of the patient's programming history available in the manufacturer's programming history database revealed diagnostics data for the date of implant, (b)(6) 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4956763
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dennis100
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« Reply #3602 on: November 22, 2017, 04:06:46 AM »

Model Number 104
Event Date 03/13/2015
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient experienced pain is in chest area with vns stimulation after vns dosing appointment on (b)(6) 2015. Device was interrogated and diagnostics ran in multiple positions: sitting, arm raised, arm extended. It is unknown if the pain is related to stimulation as there is minimal time between stimulation period (patient';s settings are 21 sec on and 0. 5 min off). The physician did not want to turn off vns due to patient';s worsening of seizure frequency. The increase in seizures is being correlated to the chest pain. The physician lowered output current to 2. 5ma and pulse width to 250 usec. Chest and neck x-rays were ordered and patient was started on new medication. The patient's generator was subsequently checked again on (b)(6) 2015 at the surgical consult. Diagnostics were run on patient in 4 different positions and lead impedance came back ok every time. After reviewing x-rays, the surgeon attributed her pain to just normal pain and discomfort from the replacement surgery. No interventions were planned and patient was told to contact surgeon if there is an increase in pain. No further information was received regarding the patient¿s increase in seizures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4819553
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dennis100
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« Reply #3603 on: November 22, 2017, 08:21:51 AM »

Model Number 102
Event Date 11/01/2012
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient noticed that her generator was not working when using the magnet for stimulation and was experiencing an increase in seizures from 1-2 seizures per day to 4-5 seizures per day. Attempts to contact the physician have been unsuccessful. The patient was scheduled to have her generator replaced, however, when the patient was seen by the physician the generator was interrogated and the battery was not at end of service. The surgery was then placed on hold for 6 months.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3086355
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dennis100
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« Reply #3604 on: November 23, 2017, 02:55:27 AM »

Model Number 103
Device Problem No Information
Event Date 06/01/2015
Event Type Malfunction
Manufacturer Narrative

Manufacturer Narrative
(b)(4). Suspect medical device udi; corrected data: the previously submitted mdr inadvertently did not provide the suspect medical device udi.

Event Description
It was reported that the patient experienced an increase in seizures after increasing the device output current from 0. 25ma to 0. 75ma. It was reported that the patient's mother reported an initial small reduction in seizures after the device was initially programmed on. It is unknown whether or not the increase is above the patient's pre-vns baseline frequency. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4906428
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dennis100
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« Reply #3605 on: November 23, 2017, 02:56:19 AM »

Model Number 105
Event Date 06/15/2015
Event Type Malfunction
Event Description
It was reported that the vns patient went to the er on (b)(6) 2015 due to an increase in seizures. It was noted that the patient's medications were adjusted a few days prior to the event. Attempts for additional relevant information have been unsuccessful to date. A battery life calculation using the available programming history showed approximately 6. 1 years remaining.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4899899
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dennis100
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« Reply #3606 on: November 23, 2017, 02:57:41 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 06/01/2015
Event Type Injury
Event Description
Follow-up with the physician's office revealed that the patient was hysterical and always attributed her issues to vns. The physician's office did not believe any of the issues the patient had alleged were related to vns. The patient's seizure that was longer in duration was due to the patient's sickness at the time that was unrelated to vns. The patient's nausea and change in sleeping pattern were due to personal issues and stress.

Event Description
It was reported that the patient experienced a seizure that lasted 10-15 minutes after an increase in device settings. The patient was seen again by the physician at which time device settings were decreased back to the lowest settings. It is unknown if the seizure was related to vns therapy. The patient feels that vns has worked very well and made a significant different for her. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description
It was reported that the patient had a recent injury to the neck area and there was concern about lead fracture and increased seizures. The physician believed that the patient's issues are psychiatric in nature and reported that the vns is performing as intended.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4910315
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dennis100
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« Reply #3607 on: November 23, 2017, 02:58:40 AM »

Model Number 103
Event Date 06/01/2015
Event Type Malfunction
Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
It was reported that the patient experienced increased seizures. Available programming history for patient was received. Attempts for additional relevant information were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4905913
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dennis100
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« Reply #3608 on: November 24, 2017, 04:19:26 AM »

Model Number 103
Event Date 11/12/2012
Event Type Injury
Event Description
On (b)(6) 2012 it was reported that the vns patient had 10-12 seizures that morning, approximately 10 head drops with loss of all muscle control which was something new, one focal seizure lasting 3-4 minutes where the patient collapsed in the bathroom, and one grand mal lasting 6 minutes. The patient called 911 and had swiped the vns magnet about 10 times which stopped the focal seizure but not the grand mal seizures. The patient was also given 7. 5mg diastat as he did not have a 10mg portion at the house. The patient was noted to have been ill the last 2-3 weeks with the flu and then had vomiting, but the patient stated that the last time he was sick was on (b)(6) 2012 and he has not had any missed medications. The patient was now also having bradycardia. The physician's office later reported that since the patient was given diastat due to his increase in seizures, this caused the bradycardia. Diastat caused the heart rate to drop; the bradycardia was a side effect of diastat and not related to vns. Attempts for further information from the physician are underway but no additional information has been received to date.

Event Description
Additional information was received on (b)(6) 2013 when the manufacturer's consultant stated that the only information that the physician¿s office was able to provide was that the incident was on (b)(6) 2012 and the patient was given ativan and diastat which is what caused the bradycardia. The bradycardia didn't have anything to vns; it was due to the patient's medication - diastat and ativan. The patient's settings were noted to be output=1ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=1. 5ma/magnet on time=60sec/magnet pulse width=250usec and then the patient came back in on (b)(6) 2012 and they increased the output current to 1. 25ma and magnet output to 1. 5ma, the rest of the settings stayed same. The office again reiterated that the event did not have anything to do with vns. No further information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2861715
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dennis100
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« Reply #3609 on: November 25, 2017, 08:59:47 AM »

Model Number 102
Event Date 07/01/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that a patient was experiencing an increase in seizures, which she felt was due to her device being at end of service. Attempts for further information have been unsuccessful to date.

Event Description
The physician did not believe that the increase in seizures was related to vns. Diagnostics were 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=5025865
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dennis100
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« Reply #3610 on: November 26, 2017, 03:30:09 AM »

Model Number 103
Device Problem Use of Incorrect Control Settings
Event Date 01/01/2013
Event Type Injury
Event Description
Clinic notes were received indicating that the vns patient was not doing well following adjustments to device settings. The patient's device settings were programmed back to previous settings during an office visit on (b)(6) 2013. The patient's device was tested and showed normal device function at the time. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Information was received from the patient's neurologist. He did not know when the settings were adjusted, but there was an increase in seizures after the adjustment. He stated that this increase in seizures was not related to vns. He also stated that programming changes, medication changes, or other external factors did not cause or contribute to the increased seizures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5007921
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dennis100
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« Reply #3611 on: November 27, 2017, 03:14:24 AM »

Model Number 102
Device Problem Battery issue
Event Date 04/01/2015
Event Type Injury
Event Description
On (b)(6) 2015 it was reported that the patient underwent prophylactic generator replacement that day. Good faith attempts were made for product return but the generator was not received for product analysis.

Event Description
Clinic notes were received which indicated that the patient had an increased number of seizures in april. The patient had over 100 seizures and normally only has about 4-50 per month. However, since that time, the seizure count has resumed its normal amount of about 40 per month. The physician indicated that the deteriorating seizure control is likely due to battery failure. The patient was referred for prophylactic generator replacement. The physician reported that he would not provide any further information. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4998986
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dennis100
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« Reply #3612 on: November 28, 2017, 03:09:18 AM »

Model Number 102
Event Date 06/01/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
The patient had prophylactic generator replacement surgery on (b)(6) 2016. The explanting facility does not return product to the manufacturer. No further relevant information has been received to date.

Event Description
It was reported that the patient has been seizure free for the entire last year, however the last month he had four seizures. The nurse practitioner noted that she is concerned that the generator may be nearing end of life. The nurse practitioner later reported that the patient has been having breakthrough seizures and that she is concerned the generator is nearing end of service. She indicated that they will monitor the patient and if he continues to have seizures then they will replace the vns generator. No causal or contributory programming changes, medication changes, or other external factors precede the onset of the increase in seizures. The nurse practitioner stated that the patient only has one type of seizure and that the patient has had three breakthrough seizures.

Event Description
Clinic notes were received regarding the patient's replacement. In the clinic notes it was mentioned that the patient had 4 seizures in (b)(6) 2015, which were the only seizures the patient had that year. The patient was referred for prophylactic generator replacement due to the battery life calculation provided to the physician. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4959682
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dennis100
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« Reply #3613 on: November 28, 2017, 03:10:22 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 07/11/2015
Event Type Injury
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: this information was inadvertently omitted from supplemental report #2.

Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
Hospital records received indicate that the patient was admitted to the hospital on (b)(6) 2015 after presenting to the emergency room with a complaint of breakthrough seizures. The records indicate that the patient experienced two seizures at her group home on the day of admission and one additional seizure at another facility prior to presenting to the emergency room of the reporting hospital. The records state that the patient could not accurately describe her seizure frequency but the current seizures are stated to be her first in about a year. The records indicate that the patient can feel her device stimulation kicking in and device function was noted to be normal. The records indicate that the patient was given anti-seizure medication at the first facility and was prescribed an additional medication at the admitting facility. No additional interventions are described. The patient was discharged on (b)(6) 2015 with instructions to follow up with primary care physicians and neurologists. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Additional information received from the patient's neurologist indicates that the patient's breakthrough seizures were diagnosed as pseudoseizures due to stress and not likely related to vns. It was not known why the patient's device was programmed to a 0. 3% duty cycle by prior providers, however, the current provider has elected not to increase the duty cycle as he is unclear regarding the patient's diagnosis of epilepsy and is referring the patient to another facility. The provider has not evaluated the patient's device since hospital discharge on (b)(6) 2015.

Event Description
A provider indicated that a patient had experienced breakthrough seizures and was admitted to the hospital through the emergency room. No further information was provided. A battery life calculation performed revealed 9. 4 years until neos = yes. Review of the available programming history indicated that the patient was implanted on (b)(6) 2006 and the device was programmed to a 0. 3% duty cycle from the date of implant through at least (b)(6) 2010 while other parameters appear to have been titrated up in a typical manner through (b)(6) 2010. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4961348
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dennis100
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« Reply #3614 on: November 28, 2017, 03:11:21 AM »

Model Number 103
Device Problem No Information
Event Date 06/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by the physician that the patient's reported increase in seizures is not believed to be related to vns. The increase in seizures was noted to be above pre-vns levels. It was also reported the patient has had several new medications added that could have caused or contributed to the reported increase in seizures.

Event Description
It was reported by the patient's grandmother that the patient has been experiencing an increase in seizures when the vns settings are titrated. The grandmother also reported that she told the physician of the increase in seizures, and in response, the physician increased the patient's medications and vns settings in the same visit. It was reported by the grandmother that the patient was only on 2 medications prior to vns therapy and now the patient is on 4 medications. It was noted the patient was seizure free for a few months following the implant and initial dosing of the vns system, until the last few months. Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5105185
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« Reply #3615 on: November 28, 2017, 03:12:03 AM »

Model Number 103
Event Date 06/01/2015
Event Type Injury
Event Description
Clinic notes were received on (b)(6) 2015 and mention that the patient had an increase in seizures in the beginning of (b)(6) 2015. On (b)(6) 2015 she had a prolonged seizure cluster in which she received diastat that led to successful resolution of her cluster. There had not been definitive provoking factors at that time. She remained at about 1 tonic seizure per day until the last week where she had one seizure that led to a fall and broke her shoulder. After this she was having 4-5 events per day consisting of tonic seizures with very quick recovery. She has not missed any doses of medications. She did tolerate the increase in onfi dose without new side effects. Notes dated (b)(6) 2015 state that it is possible that a decline in vagal nerve stimulator battery could be impacting seizure control recently. It is also mentioned that impact of pain during sleep in the last week since her fall may also be impacting seizure control recently. Notes state that given the high end settings that are in use and the fact that the patient has had some worsening of her seizure control in the recent past, they will go ahead and proceed with a replacement of the vns device. Attempts for additional relevant information have been made but have been unsuccessful to date. While surgery is likely, no surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4962052
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« Reply #3616 on: November 28, 2017, 03:13:04 AM »

Model Number 103
Device Problem No Information
Event Date 09/01/2015
Event Type Injury
Event Description
On (b)(6) 2016 clinic notes were received. The patient was referred for prophylactic generator replacement. The patient underwent generator replacement on (b)(6) 2016. The explanted generator could not be returned for product analysis as it was discarded by the hospital.

Event Description
The patient's father reported that the patient is having an increase in seizures daily at bed time and prior to awakening he will have up to 20 seizures. The patient has had many er trips and hospital admits due to increased seizure activity. The patient's father feels the device is not working. The patient was referred for prophylactic generator replacement. Although surgery is likely, it has not occurred to date. Good faith attempts for further information from the physician were unsuccessful.

Manufacturer Narrative

Event Description
On (b)(6) 2015 the physician reported that the patient's most recent settings are output=2ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=1. 8min/magnet on time=60sec/magnet pulse width=500usec. The physician stated that the increase in seizures is not related to vns. The patient was admitted this week for epilepsy surgery due to the increase in seizures. No causal or contributory programming changes, medication changes, or other external factors precede the onset of the increase in seizures. The physician was unsure of the relationship of the increase in seizure frequency to pre-vns baseline levels as the patient came to their office with a vns already implanted. The patient has multiple seizure types that all increased.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5108708
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« Reply #3617 on: November 29, 2017, 02:11:28 AM »

Model Number 103
Device Problem Migration of device or device component
Event Date 05/08/2015
Event Type Injury
Event Description
Patient was implanted with vns on (b)(6) 2015. Vns was programmed on on (b)(6) 2015. Initially, the magnet was helping with her seizures. Additional information was received that the patient's vns was removed on (b)(6) 2015. It was removed due to all of patient's symptoms. Patient also had an increase in seizures above her pre-vns baseline and started having convulsions which she did not have prior to vns. Patient never reached therapeutic levels and the device was disabled on (b)(6) 2015. Clinic notes dated (b)(6) 2015 were received indicating that since the patients last visit, patient's vns has shifted down from the original placement spot. Patient has been experiencing painful sensations in the left face and under both sides of her jaw. This spreads down the front of the left side of her neck. Patient describes the pain as pins and needles. This occurs randomly and not just when the vns is stimulation and worsens considerably with magnet mode (higher output current) stimulation. Patient has difficulty with daily activity due to the generator moving around. When the magnet was swiped, significant dystonic pulling of the left face and neck was noted associated with extreme discomfort on the part of the patient. The vns was turned off as a result. Physician's assessment was that the patient's painful facial and neck sensation and dystonic motor movements of the face and neck may represent a spread of electrical current and the entire system should be removed and replaced. Patient visited the hospital on (b)(6) 2015 because of a generalized seizure and an increase in the pain patient also had a convulsion. Noted dated (b)(6) 2015 indicates that the patient's headaches are worse since the increase in vns settings. Patient feels soreness at the vns generator site. It is implanted more medially in the chest wall near the sternum, rather than the axillary area. She feels that her vns has turned and is now vertical. This is pulling on the lead in her neck. Since the surgery, the vns has rotated and dropped inferiorly, placing a weight and stretching burden on the lead attached to the vagal nerve. Patient's normal and magnet mode output current were decreased from 0. 5 ma and 0. 75 ma to 0. 25 ma and 0,5 ma respectively. The explanted products will not be returned to manufacturer unless the patient signs a release form.

Event Description
It was reported that a patient has neuropathy at the lead site. She reported constant pain in the neck, numbness under the chin, and a lead pulling sensation. She also reported that the device has migrated and is experiencing pain from the migration at the chest site. The patient has been referred for surgery. No known surgical interventions have occurred to date.

Manufacturer Narrative
Suspect device udi: (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5088394
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« Reply #3618 on: November 30, 2017, 02:39:02 AM »

Model Number 103
Device Problem No Information
Event Date 08/08/2015
Event Type Injury
Event Description
Follow-up with the healthcare provider revealed that the patient went to the er for an increase in seizures reported at 10-20 per day. The patient was given dilantin and clonazepam in the er and was assessed overnight but was not admitted. No known surgical intervention has occurred to-date. It was later reported by the healthcare provider that the patient's device was successfully interrogated at the neurology clinic visit. No additional relevant information has been received to date.

Event Description
It was reported by the healthcare professional that systems diagnostics were performed on (b)(6) 2015, however the results were not provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5077109
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« Reply #3619 on: December 01, 2017, 02:48:19 AM »

Model Number 103
Event Date 08/12/2015
Event Type Malfunction
Event Description
It was reported that the patient does not feel that the vns is working. The patient cannot feel stimulation when she swipes the magnet. The patient feels that the device has been acting "funny" for several weeks. The patient had two seizures on (b)(6) 2015, which was reportedly an increase in seizures so the patient went to the er. While at the er, it was reported that the patient's vns was not working at all. The er was unable to locate the vns generator with the wand and an x-ray had to be done to locate it. Additional information as received that the patient feels her vns stimulating erratically, and it is somewhat painful. The patient can still not feel magnet swipes. 2 magnets have been used without success. The patient also is complaining of tiredness and seems "twitchy. " no additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5055377
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« Reply #3620 on: December 01, 2017, 02:49:21 AM »

Model Number 102
Device Problem Battery issue
Event Date 01/01/2015
Event Type Injury
Event Description
It was reported that the patient is experiencing increased seizures due to battery depletion. Patient was referred for vns replacement as a result. Additional information was received that the patient has not been seen by the neurologist since (b)(6) 2013 and that the neurologist does not have any other relevant information regarding patient. No known surgical interventions have occurred to date.

Manufacturer Narrative

Event Description
Additional information was received from the surgeon that the patient's vns was not near end of life and that the patient was referred for vns replacement surgery in error. The surgeon did not have any other relevant information to provide.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5051732
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« Reply #3621 on: December 02, 2017, 02:19:45 AM »

Event Type Malfunction
Manufacturer Narrative

Event Description
During an anonymous teleconference call for potential vns patients, an unidentified individual expressed their concern after reading a comment posted online about a patient with complex partial seizures who experienced worsening of seizures after being implanted with vns. The website where the comment was posted is also unknown. Attempts for additional relevant information is not possible as the reporter and patient are unknown.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5162747
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« Reply #3622 on: December 02, 2017, 02:20:24 AM »

Model Number 103
Event Date 09/23/2015
Event Type Injury
Event Description
It was reported that a patient was in the hospital to undergo video electroencephalography due to "more spacey episodes. " attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5164045
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« Reply #3623 on: December 02, 2017, 02:21:03 AM »

Model Number 102
Event Date 09/25/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that "patient has swipe magnet not feel. Doctor increase headaches and stimulation. " it was unclear what was meant by this. It was also reported that the patient feels the battery is low because she has an increase in seizures. She has partial seizures. She swipes the vns magnet six to eight times a day. It was later clarified that the patient doesn't feel that the vns is working because when she swiped the magnet, she used to feel a sensation in her neck but she doesn't feel that she has the same sensation. Good faith attempts for further information from the physician were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5165383
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« Reply #3624 on: December 03, 2017, 03:34:54 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 09/07/2015
Event Type Malfunction
Event Description
It was reported by the patient that he could be doing better, but he lost his vns magnets. The company representatives stated she would ship a patient magnet kit to the patient. The patient also noted he had a few "attacks" a few weeks ago and an eeg was performed. The patient has yet to re-establish care with his following neurologist and he was encouraged by the company representative to make an appointment as he needs to be followed by a physician. Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was reported by the patient that he had a seizure and used the magnet, but he did not feel the vns stimulate. It was noted the seizure lasted about 10 minutes, but he does not recall his recovery time. The patient also reported his seizure activity has increased recently. It is unknown if the reported increase in seizures is above pre-vns levels. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description
It was reported by the patient on (b)(6) 2015, during a check in call by the company representative, that the patient was in the emergency room and that he came to the hospital two days ago. No additional information was provided. It was later reported by the patient that his physician who monitors his diabetes told the patient that it is a possibility that his medications for diabetes are causing the seizures, but the physician does not know which one. The patient has not yet followed up with his following neurologist. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5145443
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dennis100
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« Reply #3625 on: December 03, 2017, 03:35:43 AM »

Model Number 103
Event Date 08/01/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that adjusting vns settings has recently caused the seizures to worsen. The patient reported that the physician has not programmed the device off despite the vns "affecting her heart". It is unknown whether or not the increase in seizures is above the patient's pre-vns baseline frequency. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description
Further follow-up with the physician revealed that the patient continues to have more seizures, but it was suspected that these were non-epileptic events; therefore, no medication changes were made. The vns was interrogated and found to be working as intended with ifi - no. Device settings were reprogrammed on (b)(6) 2015 and the patient tolerated this well. It was reported that the patient has heart conditions that are unrelated to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5141418
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dennis100
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« Reply #3626 on: December 04, 2017, 02:07:45 AM »

Event Type Injury
Manufacturer Narrative

Event Description
An article titled "vns lead removal or replacement surgical technique, institutional experience and literature overview" was published on (b)(6) 2015 which included adverse events involving 7 vns patients. One patient presented vocal cord paralysis and underwent lead replacement. Two patients presented lead fractures, lack of efficacy and paresthesia and they underwent explant. Two patients presented increased seizures and underwent vns replacement. Two patients suffered small laceration of the internal jugular vein which was repaired with a suture and which occurred during lead explant surgery due to lack of efficacy without replacement of the lead. The manufacturer report # 1644487-2015-05981 involves the patient who presented vocal cord paralysis. The manufacturer report # 1644487-2015-05982 involves the first patient who presented lead fracture, lack of efficacy and paresthesia. The manufacturer report # 1644487-2015-05983 involves the second patient who presented lead fracture, lack of efficacy and paresthesia. The manufacturer report # 1644487-2015-05984 involves the first patient who presented increased seizures and underwent replacement. The manufacturer report # 1644487-2015-05985 involves the second patient who presented increased seizures and underwent replacement. The manufacturer report # 1644487-2015-05986 involves the first patient who suffered small laceration of the internal jugular vein. The manufacturer report # 1644487-2015-05987 involves the second patient who suffered small laceration of the internal jugular vein.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5116364
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« Reply #3627 on: December 04, 2017, 02:08:39 AM »

Model Number 100
Event Date 11/01/2000
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2004 reported that the patient experienced generalized tonic-clonic seizures after his vns was programmed to rapid cycling in (b)(6) 2000. Once the duty cycle was programmed back, the patient no longer had generalized tonic-clonic seizures. The device was checked on (b)(6) 2004, and system diagnostics were within normal limits, indicating proper device function. No additional relevant information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5117672
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dennis100
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« Reply #3628 on: December 05, 2017, 02:57:30 AM »

Event Date 01/01/2010
Event Type Malfunction
Manufacturer Narrative

Event Description
On (b)(6) 2012 it was reported that since the patient's vns revision surgery in (b)(6) 2010 his epilepsy has worsened. 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=2854701
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dennis100
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« Reply #3629 on: December 06, 2017, 03:20:47 AM »

Model Number 106
Event Date 11/01/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported on (b)(6) 2015 that the patient is having an increase in seizures. The patient was implanted in (b)(6) 2015 and is in the process of being titrated up. He is currently up to 1. 0 ma. Prior to vns the patient had 1-2 seizures per week. The last few weeks his seizures have been around 3-4 a week. But he stated that he is going to continue the titration process at this point. The physician stated that there have been no medication changes but there may be some stress although when the patient was seen he was not in any stress and denied being stressed. He stated that all diagnostics were within normal limits. The physician is unclear on the cause of the seizures since the only change has been the vns device implantation. At this point though the physician is not sure what the cause of seizures is but may continue titration or disable for a period to see what happens.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5333536
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