It was reported originally that the patient was having throat discomfort after his last replacement which he believed to be due to vns stimulation.Later on (b)(6) 2017 the patient was experiencing vocal cord paralysis and was having difficulty managing his airway after consulting an ent.With the magnet in place, the ent could see some movement in the left vocal cord only and the patient was better able to maintain his airway.With the magnet removed and vns back on, the vocal cord stopped moving and his oxygen saturations declined.The device was programmed off.Additional relevant information has not been received to-date.
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Later information from the physician provided on 10/25/2017 that the patient was experiencing urine retention, lethargy, difficulty eating and drinking, and needed oxygen support.He had been taken to the hospital for difficulty breathing and maintaining oxygen levels.On (b)(6) 2017 a lot of swelling was found in the throat and was admitted to the hospital a day later.On (b)(6) 2017 the patient was taken to the icu and was put on a ventilator and the airway was almost completely swollen shut.On (b)(6) 2017 the vocal cord paralysis was identified and showed improvement after using the magnet to disable vns.On (b)(6) 2017 movement was seen in both the left and right vocal cord although still partially paralyzed, the patient's stats were normalizing well.The device was turned off at that time.On (b)(6) 2017 follow-up with an ent showed a lot of movement was seen in vocal cord but still had partial paralysis.It was reported that the seizure frequency has actually decreased since turning off the vns device.Diagnostics performed by the company representative on (b)(6) 2017 were within normal limits.
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