The patient consulted another physician, who believes that the patient's events are due to the placement of the device as opposed to the device itself.The patient complains of constant pain around the superior portion of the chest incision and at the neck incision where the electrode appears to course above the platysma muscle.The discomfort appears to be related to the fact that the implant was placed too superficially, such that it is in direct contact with the dermis and is irritating the skin.The patient states that these symptoms have been present since the device was placed.During stimulation, the patient was extremely uncomfortable and noted the following symptoms: sensation of tasting something burning, pulling sensation in her neck, burning sensation in the neck and near the generator, coughing and nausea.There was no discoloration or heating of the skin around the generator that the physician observed.Per the physician, the above symptoms would be most consistent with inadvertent placement of the device on the hypoglossal or glossopharyngeal nerve instead of the vagus nerve, or potentially placement too superiorly on the vagus, or current spread to those nerves,.Per the physician's opinion, these are not necessarily indicative of a malfunction in the device itself.In addition, the recorded impedance of the device was 2183 ohms confirms no lead related issues.Per the implant operative report, the lead was implanted on the vagus nerve near the jugular vein and carotid artery.No other relevant information was obtained from the operative report as to the cause of pain.Patient underwent full revision surgery on (b)(46 2016.The explanted products were not received to date.
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