Device 2 of 2, reference mfr.Report# 3006705815-2018-01314: the patient is implanted with two leads and the manufacturer is unable to determine which lead is liable.It was reported the patient underwent a scs trial implant procedure.On (b)(6) 2018 the patient began complaining of a headache.After the trial, as the surgeon removed the trial leads ((b)(6) 2018), cerebrospinal fluid leakage occurred.The physician applied a pressure bandage, and scheduled the patient to receive a blood patch on (b)(6) 2018.The patient has been having headaches occasionally, but no further intervention is expected.
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