It was reported a cerebrospinal fluid (csf) leak occurred while the physician was attempting to place the lead at l5, during a drg trial implant procedure that took place on (b)(6) 2020.As a result, the physician performed a blood patch and the patient was asymptomatic and procedure was completed.
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Product #1 pi main [pi-2020-0192981-01].It was reported to abbott that during a trial procedure, a cerebral spinal fluid (csf) leak occurred.The drg trial lead had been placed at l5 when the wet tap occurred.The physician performed a blood patch and the procedure was completed.The patient did not show any symptoms.All information pertaining to this event has been reviewed, issue was not product related, and no further action is required at this time.
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