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dennis100
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« Reply #3570 on: November 11, 2017, 04:43:47 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 05/12/2010
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported through clinic notes that the patient reported that since he was implanted with the vns, the patient had had a worsening in seizures, both in frequency and intensity. He also had significant discomfort in the chest, adjacent to the pulse generator. The physician referred the patient for explant of generator and lead so that the patient could have an mri. The patient's generator battery had reportedly been completed depleted for several years. The programming history database found that the patient's generator battery was disabled due to end of service in (b)(6) 2017. The lead and generator were explanted but the suspect product has not been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6924716
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« Reply #3571 on: November 12, 2017, 03:48:35 AM »

Model Number 103
Event Date 12/01/2014
Event Type Malfunction
Event Description
It was reported that the patient has experienced a recent and moderate increase in seizures. The physician reported that the patient's mother is placing the patient under an electric blacks and the physician was inquiring if the heat could negatively impact the vns. Attempts to obtain additional relevant information have been unsuccessful to date. It is unknown whether or not the seizures are an increase above the patient's pre-vns baseline frequency.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4424385
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dennis100
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« Reply #3572 on: November 13, 2017, 03:12:10 AM »

Model Number 103
Event Date 11/01/2014
Event Type Injury
Event Description
It was reported that the vns patient had been experiencing nocturnal seizures for the past two weeks. The patient stated that the seizures were convulsions and did not cause her to lose awareness. The patient also reported experiencing a change in seizure pattern; she stated she began having other feelings ¿inside¿ along with automatisms. It was noted that the magnet mode stimulation had been helpful in aborting the patient¿s seizures. The patient was instructed to activate magnet mode stimulation a few times before bedtime or during the day. The patient denied any life stressors but believed her ipad may have been triggering her seizures. The patient was instructed to visit with the following physician. Attempts for additional relevant information will be made.

Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient had been experiencing an increase in seizures and a new seizure type in november and (b)(6) of 2014. The seizures were attributed to stress during the holiday season. The patient was seen on (b)(6) 2015 and was doing well. The seizures had resolved and the patient¿s device was functioning well. There was no mention of potential issues with her ipad during the office visit and no further information was obtained as the patient was doing well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377912
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dennis100
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« Reply #3573 on: November 14, 2017, 02:57:51 AM »

Model Number 102
Event Date 01/12/2015
Event Type Malfunction
Event Description
It was reported that the recently implanted vns patient experienced successive seizures nonstop for 30 minutes. The patient was taken to the or and the seizures stopped at that time. The patient¿s device output current was increased from 0. 25ma to 0. 5ma earlier that day. No intervention was taken. It was noted that the patient had not previously experienced seizures of this type. No medication changes preceded the onset of the event. Prior to vns, the patient averaged three seizures per day. Diagnostic results showed normal device function at the time of implant. The physician indicated that all of the patient¿s seizure types had increased. The patient was reported to be stable now.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4491065
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dennis100
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« Reply #3574 on: November 14, 2017, 02:58:48 AM »

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

Event Description
It was reported that the patient was experiencing an increase in seizures. The patient's father is concerned that the generator battery is low. The patient was scheduled to see the physician to have the device checked. Attempts to obtain additional relevant information have been unsuccessful to date. It is unknown whether or not the increase is above the patient's pre-vns baseline frequency.

Event Description
It was reported on (b)(4) 2015 that the patient underwent prophylactic generator replacement on (b)(6) 2015. It was reported that the generator could not be returned for product analysis as the hospital does not return explanted devices.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4536741
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dennis100
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« Reply #3575 on: November 14, 2017, 02:59:48 AM »

Model Number 102
Event Date 01/27/2015
Event Type Malfunction
Event Description
It was reported on that the vns patient was experiencing an increase in seizures and that magnet mode stimulation was no longer effective in aborting seizures. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. A battery life calculation using the available programming history showed approximately 6. 7 years remaining. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
Further follow-up revealed that at the patient's visit on (b)(6) 2015 the physician indicated that the patient's medication dosages were to be adjusted due to the adverse events. The patient's mother was reluctant to have medication changes made at that time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532538
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dennis100
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« Reply #3576 on: November 14, 2017, 03:00:35 AM »

Model Number 103
Event Date 02/02/2015
Event Type Malfunction
Manufacturer Narrative

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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« Reply #3577 on: November 14, 2017, 03:01:26 AM »

Model Number 105
Event Date 01/01/2015
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history.

Event Description
It was reported that the patient is having an increase in seizures. Good faith attempts for further information have been unsuccessful.

Event Description
The patient¿s programming history was reviewed and a battery life calculation was performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4474774
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dennis100
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« Reply #3578 on: November 15, 2017, 03:00:01 AM »

Model Number 102
Event Date 02/25/2015
Event Type Malfunction
Event Description
It was reported that the vns patient was at the hospital and had experienced an increase in seizures. Attempts for additional relevant information have been unsuccessful to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. A battery life calculation using the available programming history showed approximately 4. 5 years remaining.

Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
Additional information was receive stating that the vns patient's increase in seizures was not related to vns but rather due to aspiration pneumonia. The patient's seizures had returned back to baseline levels.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4623191
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dennis100
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« Reply #3579 on: November 15, 2017, 03:00:44 AM »

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

Event Description
It was reported that the patient recently underwent extracorporeal shockwave lithotripsy. The patient's mother was wondering if this may be causing the patient's increase in seizures. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4541544
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dennis100
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« Reply #3580 on: November 16, 2017, 03:17:25 AM »

Model Number 103
Event Date 02/01/2015
Event Type Malfunction
Event Description
It was reported that the patient is experiencing an increase in seizures. The physician wants the device checked to see if the battery is at end of service; however, the device has not been checked to date. It was reported that surgery will be scheduled if the device is at end of service and is the cause of the increase in seizures. No known surgical intervention has been performed to date.

Manufacturer Narrative

Event Description
An implant card was received indicating that the vns patient underwent generator replacement surgery on (b)(6) 2015. The explanted device has not been returned to date.

Event Description
The explanting facility discarded the explanted device; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4573617
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« Reply #3581 on: November 16, 2017, 03:18:57 AM »

Model Number 105
Event Date 07/01/2014
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient's seizures have increased in intensity and quantity. The patient requested to see a new vns physician for possible change in settings or device explant. It is unknown whether or not the patient has been seen by one of the referred physician's. The patient indicated that she would get referral to the new physician by her primary care physician. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4733379
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dennis100
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« Reply #3582 on: November 17, 2017, 04:06:52 AM »

Model Number 101
Device Problem No Information
Event Date 03/26/2015
Event Type Malfunction
Event Description
It was reported on (b)(6) 2015 that the patient was recently seen and has a return of his seizure symptoms and it is stated as becoming worse. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was reported on (b)(6) 2015 that this patient had a replacement on (b)(6) 2015. The explanted generator is not available for analysis as the explanting facility is a non-return site.

Event Description
It was reported from the nurse at the physician's office that the patient has not been seen for the issue of increase in seizures. The last time the patient was seen was in (b)(6) 2015. No additional information from the nurse was available. On (b)(6) 2015 it was reported that the patient is scheduled for a prophylactic replacement. The surgery is scheduled but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4707948
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dennis100
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« Reply #3583 on: November 17, 2017, 04:07:42 AM »

Model Number 103
Event Date 03/19/2015
Event Type Malfunction
Event Description
It was reported that the vns patient had been experiencing an increase in seizures and having pain at the generator site. It was noted that the patient had a fall when the issues first began. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. A battery life calculation using the available programming history showed greater than 10 years remaining. No further information relevant to the event has been received to date.

Manufacturer Narrative
Review of the available programming and diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4719943
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dennis100
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« Reply #3584 on: November 17, 2017, 04:08:45 AM »

Model Number 103
Event Date 03/01/2015
Event Type Injury
Manufacturer Narrative
Corrected data: new information received changes the event from a product problem to an adverse event. This was inadvertently left off of supplemental mfr. Report #01. Corrected data: new information received changes the event from a product problem to an adverse event. This was inadvertently left off of supplemental mfr. Report #01.

Manufacturer Narrative

Event Description
It was reported that the patient has experienced a possible increase in myoclonic seizures. The patient's father indicated that the patient is bedridden and they plan to follow-up with the treating neurologist. It is unknown whether or not the increase is above the patient's pre-vns baseline frequency. No additional relevant information has been received to date.

Event Description
Follow up indicated that it was not an increase in myoclonic seizures that had occurred, it was an increase in generalized seizures, which are unusual for the patient. The patient's father does not know whether the increase in seizures is above the patient's pre-vns baseline frequency. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4707252
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dennis100
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« Reply #3585 on: November 18, 2017, 03:02:11 AM »

Model Number 105
Event Date 02/07/2014
Event Type Injury
Event Description
An article titled "autistic spectrum disorder, epilepsy, and vagus nerve stimulation" was received which included a vns patient who initially experienced improved seizure control following vns implant but was not maintained. At the age of 9, it was observed that the patient was having up to 10 episodes per day of deep inhalation, pupil dilation, truncal flexion, and upper extremity rigidity which lasted up to 30 seconds. Eeg monitoring at that time revealed epileptiform activity arising from the frontal lobes bilaterally. The patient was given lamotrigine which decreased the number of seizures to 3-6 per day. The medication was later increased to the maximum dosage and the seizure activity decreased to once every two days. At the age of 10, the patient began experiencing an increase in seizures with episodes occurring daily and lasting up to 30 seconds. Zonegran was added to the patient's medication regimen which augmented seizure control but with significant side effects. The patient was later weaned off zonegran and implanted with a m105 pulse generator. Prior to implant, the patient was having 1-2 seizures daily. The patient's device settings were titrated up after 5 weeks post-implant, and the patient experienced a decrease in seizure severity and duration (seizures lasting 10 seconds of less). Six months following implant surgery, the seizure frequency increased to 6-10 per day. The patient's device settings continued to be titrated up. At 13 months post-implant, the device settings were increased and the patient's seizure activity decreased to 3-4 per day. Follow-up with the patient¿s following physician revealed that the reason for the increase in seizure frequency was unknown. The patient¿s parents believed vns was not effective in controlling the patient¿s seizures.

Manufacturer Narrative
Hull mm, madhavan d, zaroff cm. Autistic spectrum disorder, epilepsy, and vagus nerve stimulation. Childs nerv syst. 2015 apr 29.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4803280
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« Reply #3586 on: November 18, 2017, 03:03:04 AM »

Model Number 102
Event Date 04/25/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the believed cause for the increase in seizures was due to patient non-compliance.

Event Description
Clinic notes dated (b)(4) 2013 note that the patient has recently undergone vns implant and has experienced more seizures since the device was programmed on two weeks prior. Device settings were adjusted. It is unknown whether or not the increase was 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=4803521
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« Reply #3587 on: November 18, 2017, 03:03:50 AM »

Model Number 103
Event Date 01/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was referred for generator replacement due to an increase in seizures above the patient's pre-vns baseline frequency. It was reported that the increase in seizures have resulted in head injuries and that the referral for surgery was prophylactic based on the seizures and amount of time the generator had been implanted. The physician reported that device diagnostics were within normal limits. The patient underwent generator replacement. The explanted generator has not been received for analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4650197
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« Reply #3588 on: November 18, 2017, 03:04:44 AM »

Event Type Malfunction
Event Description
A publication titled ¿efficacy of neuromodulation therapy with vagus nerve stimulator in patients with drug-resistant epilepsy on unchanged antiepileptic medication regimen for 24 months following the implant¿ by chayasirisobhon et. Al. Was received which contained adverse events involving vns patients. The publication indicated that eleven patients were either non-responders to vns or had worsening of seizure frequency following implant. The authors noted that the patients¿ and the treating neurologists¿ desired to achieve a decreased dose and reduced number of aeds after vns implantation which may have caused or contributed to the event. It is unknown how many of the 11 patients were non-responders or how many experienced increased seizure frequency. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
Chayasirisobhon s, cahan l, choi sh, enos b, hwang j, et al. (2015) efficacy of neuromodulation therapy with vagus nerve stimulator in patients with drug-resistant epilepsy on unchanged antiepileptic medication regimen for 24 months following the implant. J neurol neurophysiol 6: 268. Doi:10. 4172/2155-9562. 1000268.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4664751
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« Reply #3589 on: November 18, 2017, 03:05:25 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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« Reply #3590 on: November 18, 2017, 03:06:03 AM »

Event Date 01/01/2013
Event Type Malfunction
Event Description
It was reported on (b)(6) 2015 that a patient was having more seizures in the last 2 years. The patient was advised to follow-up with the physician. He believes the output current is 1. 5ma. Attempts were made for more information; however, no further information was able to be provided by the patient's physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4673415
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« Reply #3591 on: November 19, 2017, 02:04:26 AM »

Model Number 103
Event Date 04/01/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient's replacement never occurred and he has now been referred for generator replacement due to neos (near end of service). The new referral due to neos indicates that the patient was most likely not at neos when the increase in seizures was first reported as the initial report was over 1 year ago. No known surgical interventions have been performed to date.

Event Description
It was noted the patient was referred for a model 106 generator replacement as the patient is at a great risk for sudep. The patient was referred for generator replacement surgery; however, no know surgical interventions have been occurred to date.

Event Description
It was reported by the company representative that the device is not neos = yes (near end of service), but is still at ifi = yes (intensified follow-up indicator), and is still showing yellow. No known surgical interventions have occurred to date.

Event Description
It was reported that the patient's seizures have been increasing. The physician feels that the patient's device may be nearing end of service. The patient was referred to surgeon. It is unknown whether or not the increase in seizures was above the patient's pre-vns baseline frequency. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical intervention has been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4771856
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« Reply #3592 on: November 19, 2017, 02:05:08 AM »

Model Number 102
Event Date 04/01/2015
Event Type Malfunction
Event Description
It was reported that the patient has experienced more seizures and has lost all of her magnets. It is unknown if the seizures are an increase above pre-vns baseline frequency. The patient was supplied new magnet. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4762573
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« Reply #3593 on: November 19, 2017, 02:06:23 AM »

Model Number 104
Device Problem No Information
Event Date 06/01/2013
Event Type Malfunction
Event Description
It was reported that the patient's generator showed ifi - yes. The physician was concerned that this was premature. A battery life calculation was performed which showed the ifi condition is an expected event based on device settings.

Event Description
It was reported that the patient has experienced an increase in seizures since prophylactic generator replacement in (b)(6) 2013. It was reported that until 2012 the patient's maximum seizures were 8 a year and in 2013 the patient experienced 34 seizures and 41 seizures in 2014. Multiple device settings changes were made, but the seizures continued. It was reported that device diagnostics were within normal limits (2006 ohms).

Event Description
Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4757441
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« Reply #3594 on: November 19, 2017, 04:02:31 AM »

Model Number 103
Event Date 03/06/2014
Event Type Malfunction
Event Description
It was reported from a nurse at the patient's physician's office that the patient was last seen on (b)(6) 2015 and has been doing great. She said that the increase in seizures back in 2014 was not at all thought to be related to vns. She said nothing was really done for intervention for that increase so it must have just improved on it's own.

Manufacturer Narrative

Event Description
Clinic notes were received on (b)(4) 2015 and dated (b)(6) 2014. Notes state that the patient¿s mom thinks seizures are worse and the patient's teacher thinks he is having breakthrough seizures. Notes dated (b)(6) 2015 state that the patient is doing well. Has had no seizures since (b)(6) 2014.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4745626
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« Reply #3595 on: November 20, 2017, 03:52:48 AM »

Model Number 103
Event Date 01/01/2015
Event Type Injury
Event Description
Clinic notes were received for patient¿s generator replacement referral. Notes dated (b)(6) 2015 indicate that the patient is not sure if the vns is functional or not. Vns was interrogated and reprogrammed to higher output current settings on (b)(6) 2015. Additional information was received that the patient questions function of vns as he had been having more seizures than usual. Patient¿s pre-vns baseline is unknown and medications were recently changed. Patient underwent generator replacement on (b)(6) 2015 and the explanted generator was reported to have been discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4752215
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« Reply #3596 on: November 20, 2017, 03:53:33 AM »

Model Number 102
Event Date 05/21/2015
Event Type Malfunction
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator and the lead passed all functional tests prior to distribution.

Event Description
It was reported that the vns patient had presented increased seizures. Interrogation was run and it was confirmed that the parameters were correctly programmed. The patient¿s vns system was tested and system diagnostics returned impedance result within normal limits with dcdc code=1. Normal mode diagnostics were attempted but they could not be completed. It was reported that the medical professional had experienced difficulties when running normal mode diagnostics during the previous visit, but they could be completed eventually. Review of manufacturing records confirmed that the generator and the lead passed all functional tests prior to distribution. Attempts to obtain further information have been unsuccessful to date. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4874127
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« Reply #3597 on: November 20, 2017, 03:54:12 AM »

Model Number 102R
Event Date 04/10/2015
Event Type Malfunction
Event Description
It was reported that the vns patient was experiencing an increase in seizures. The patient¿s device was tested and diagnostic results showed normal device function. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4746462
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« Reply #3598 on: Today at 03:12:35 AM »

Model Number 104
Event Date 03/17/2015
Event Type Injury
Event Description
Clinic notes were received indicating that the vns patient had been experiencing an increase in seizure duration and seizure frequency which was noted to be at or below pre-vns baseline levels. The patient¿s device was reportedly at end of service. A battery life calculation using the available programming history showed approximately 0. 5 years remaining. The patient underwent generator replacement surgery on (b)(6) 2015. The explanted generator was returned to the manufacturer for analysis. The as-received generator showed an ifi=yes condition. The battery did not display a near end of service or end of service condition during product analysis. There were no performance or any other type of adverse conditions found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4872720
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dennis100
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« Reply #3599 on: Today at 03:13:53 AM »

Model Number 102
Event Date 02/04/2015
Event Type Injury
Event Description
Follow-up revealed that the physician believed the patient¿s issues would resolve following replacement of the patient¿s generator battery. An implant card was received indicating that the patient underwent generator replacement surgery on (b)(6) 2015. The explanting facility discarded the explanted device; therefore, no analysis can be performed.

Manufacturer Narrative

Event Description
Clinic notes were received indicating that the vns patient was referred for generator replacement surgery due to a depleting battery and an increase in seizures. The patient's device was tested during an office visit on (b)(6) 2015 and diagnostic results showed normal device function and battery status = ok. Since the patient's last office visit on (b)(6) 2015, the patient began having two amnestic events per month along with "zoning out" spells. The patient denied any missed dosages of medications or any illness, and the patient's last lab tests showed medication levels within normal limits. A battery life calculation using the available programming history showed approximately 2 years remaining. No known surgical interventions have occurred to date. No further information relevant to the event has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4872598
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