It was reported ((b)(6)) the patient experienced loss of sensation in their left leg following an scs implant procedure on (b)(6) 2018.Ct scan revealed some air/fluid in the subarachnoid space.Subsequently the patient regained sensation and mobility in the leg.The physician stated the nerve fibers may have been irritated while gaining access to the epidural space during the implant and the patient's symptoms were improving.No further action taken at the time as the patient¿s symptoms were improving.However, the patient passed away on (b)(6) 2018 due to deep vein thrombosis leading to a pulmonary embolism.The patient had comorbidities and that the death was a result of these comorbidities.The reason stated was the time spent on the table during the procedure.Reportedly the issue was not related to the device.
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