It was reported within clinic notes date (b)(6) 2016 that the patient had a notable increase in seizures over the last 2 months when they were previously stable.The number of seizures still seemed to be less than the pre-vns baseline value; however, it was noted there was a warning message when checking the vns which showed high impedance.The vns was not programmed off after the high impedance was observed.Additionally, the patient was could not feel the device stimulating anymore.An implant card was later received which showed the patient's revision surgery occurred on (b)(6) 2016.Attempts for additional relevant information have been unsuccessful to date.
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It was later reported by the physician's office that if the physician left the patient programmed on, it would have been due to the patient's severe epilepsy and there would be a greater risk in programming the vns off.Additionally, it was noted when the vns was working correctly, the patient would have 1 to 2 seizures per month.The seizures were shorter, less severe, and caused less injuries then prior to vns.When the device began to malfunction, the patient's seizures went up to 4 to 5 seizures per month.The patient's pre-vns baseline level was explanted to be 4-8 seizures per month, which were longer, more severe, and caused more injuries.
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