Device 2 of 2.Reference mfr report: 1627487-2014-02443.It was reported a csf leak occurred during the patient's scs trial.The procedure was successfully completed with no issues other than normal procedure discomfort.The patient did not have a headache or nausea following the procedure until later that evening.On (b)(6) 2014, the patient was treated for nausea and significant pain on her left side.The physician examined the patient's surgical site and when he pressed on the area around the leads csf was observed coming out from the surgical site.The patient's leads were removed, and the pain on her left side subsided.Follow up on (b)(6) 2014 identified the physician reported the patient's headache came back and a blood patch would be performed.
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