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It was reported that the vns patient has new small seizures and balance disorders in addition to his usual seizures.No end of service flag was seen during interrogation.A battery life calculation using the available programming history showed approximately 4.6 years left until near end of service is yes.Additional information was received from the physician with all data regarding the patient's follow-up records since the vns implantation in (b)(6) 2012: on the visit 1 in (b)(6) 2012, the device was programmed at 0.25ma output current - 250¿sec pulse width - 20hz frequency - 30sec on time and 5min off time.No special adverse event was and everything was ok.On the visit 2 in (b)(6) 2013, the patient was stable.He has spent 1 week without seizure (after vns activation) which is rare.He had some seizures during the (b)(6) period.The output current was increased at 0.5ma.On the visit 3 in (b)(6) 2013, it was found that the patient's seizures increased a little in 2 months.The parents reported dysphonia and small cough but the patient's mood had improved well.The output current was increased to 0.75ma without any adverse event.No cough was noted.On the visit 4, it was reported that the patient spent 9 days without seizures.The vns stimulation was well tolerated but some episode of cough was reported.The output current was increased to 1ma.System diagnostics returned impedance results within normal limits.On the visit 5, some episode of fever was reported (but not more than 38°c).The cause was unknown but, as reported by the physician, this is a known event to encephalopathic patients with lennox gastaut syndrome.No infection occurred.The output current was increased at 1.25ma.On the visit 6 in (b)(6) 2013, it was reported an increases in seizures but not intense.It was reported that this could be related to patient's emotions.The output current was increased at 1.5ma.On the visit 7 in (b)(6) 2013, frequent seizures were noted but not intense.It was reported by the caregivers that the vns magnet was more used because it stops immediately 80-90% of seizures.The output current was modified to 1.75ma and the frequency was increased to 30hz.On the visit 8 in (b)(6) 2013, the patient seizures frequency was stable and not intense.No voice alteration and cough were reported.The output current was increased at 2ma and the pulse width to 500¿sec.On the visit 9 in (b)(6) 2013, it was noted that the patient mood and behavior were improved well.But it was reported that the patient had one big seizure and fall.Small tonic seizures were noted too.The output current was changed to 2.25ma.On the visit 10 in (b)(6) 2014, the physician reported that a positive evolution of the situation was noted.A small cough was reported.System diagnostics returned impedance results within normal limits.The duty cycle was changed by modifying the off time from 5min to 3min.On the visit 11 in (b)(6) 2015, a progressive increase in seizures was noted during the past 7 months.No change in medications was performed.It was reported by the physician that this could probably due to the modification of duty cycle (from 5 to 3min off time).The physician decided to change back the duty cycle to the initial settings.System diagnostics returned impedance results within normal limits.On the visit 12 in (b)(6) 2015, it was reported that since the duty cycle was modified back to initial settings, an improvement was noted; seizure reduction was noted.It was reported that the patient was still sensible to emotions.System diagnostics returned impedance results within normal limits.Vns device was functioning perfectly.On the visit 13 in (b)(6) 2016, it was reported that since (b)(6) 2015 the patient had more seizures.It was reported that on (b)(6) 2016, the patient had a big seizure and fall.That day, he had pallor, muscle spasms, brief respiratory arrest and wound on eyebrow which was treated by antibiotics.It was reported that the patient had later 2 other big unusual seizures: they were generalized tonic chronic seizures.System diagnostics returned impedance results within normal limits.Vns device was functioning perfectly.The output current was changed to 2.75ma.On the visit 14, on (b)(6) 2016, the patient was seen for a follow-up of lennox gastaut syndrome.Eeg was ok with some improvement.It was reported that the patient had ambulation difficulties and fall; he could not stay up for a long time.An increase of hemiparesis was reported.Nevertheless, patient's seizures reduction was noted.The vns stimulation was well tolerated.System diagnostics returned impedance results within normal limits and the near end of service flag was no.It was reported that the last vns parameters were at 2.5ma output current ¿ 30hz frequency ¿ 500¿sec pulse width ¿ 30sec on time ¿ 5min off time.Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
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