It was reported that the patient had significant swelling at the electrode and generator sites.It was initially thought that the patient had an infection, but that was ruled out.The patient then had a nuclear medicine scan, which showed that the patient had lymphatic fluid in the soft tissue surrounding the electrode site and was leaking down to the chest pocket as well.The patient was feeling painful stimulation in the neck, which the physician attributed to the electrode site being irritated and swollen.It was determined that the fluid collection was due to the implant location of the electrodes.The physician performed lead revision surgery on (b)(6) 2016 to replace the lead and position the new electrodes in a different location on the nerve.The physician did not observe any fluid when he was performing the lead revision surgery.The explanted lead was received on (b)(6) 2016.Analysis was approved on (b)(6) 2016.Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead.Other typical wear and explant related observations, no anomalies were identified in the returned lead portion.
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