Device 1 of 3.Ref mfr reports: 1627487-2014-03394 and 1627487-2014-00395.It was reported the pt went to the er and was subsequently admitted to the hosp for 3 days due to post-operative pain in addition to leg weakness which began the week of implant and became worse over the course of 2 weeks.Ct scans revealed no anomalies.It was also reported although the pt's pain was improving at the time of discharge, the physician later decided to explant the scs system as he/she was also having concerns regarding the pt's mental health.
|