Clinic notes were received indicating that the vns patient believed something was wrong with her lead during an office visit on (b)(6) 2014.The patient was experiencing neck pain, so the physician subsequently lowered the patient¿s device settings.During an office visit on (b)(6) 2014, the patient¿s device was tested and diagnostic results showed normal device function.The patient had a seizure in the office in which she was unresponsive and leaning her head back and forth with her eyes closed.No shaking or rhythmic movement was noted.The magnet was used and the seizure lasted approximately three minutes.The patient opened her eyes but was unresponsive for several minutes.The patient was unaware of the seizure.Since her last office visit on (b)(6) 2014, the patient had eight gtc seizures and had been to the er twice.The physician was questioning the battery status of the patient¿s device.A battery life calculation using the available programming history showed approximately three years remaining until neos = yes.The patient underwent generator replacement surgery on (b)(6) 2014.The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.
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