It was reported the patient underwent a trial procedure on (b)(6) 2016.During the procedure, the physician encountered difficulty advancing the lead.As such, the physician removed both the lead and needle during which time clear fluid came through the needle.The physician then re-inserted the needle and passed the lead through successfully.It was reported a day after that the patient's dressing appeared damp.On (b)(6) 2016 the patient was admitted to have a craniotomy performed.The trial lead was removed during the procedure.The manufacturer was notified on (b)(6) 2018 via a medical records review that the patient passed away.The records indicated the patient had experienced a cerebrospinal fluid leak (csf) which developed into a subdural hematoma; these manifestations were indicated to have resulted in the patient's death.
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