Model Number 3086 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); Headache (1880); Visual Impairment (2138)
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Event Date 03/29/2018 |
Event Type
Injury
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Manufacturer Narrative
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In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.
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Event Description
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Device 2 of 2.Reference mfr.Report: 3006705815-2018-00815.It was reported during the patient's trial procedure on (b)(6) 2018, the patient suffered a csf leak while the physician inserted the needle in the desired location.A blood patch was performed and the procedure was completed as planned.The leads were removed on (b)(6) 2018.The patient reportedly has a headache which has been gradually improving.
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Event Description
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Device 2 of 2.Reference mfr.Report: 3006705815-2018-00815.Follow-up identified the patient underwent a second blood patch on (b)(6) 2018.The patient's headache has resolved; however, the patient developed double vision.The trial procedure was reportedly successful.
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Event Description
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Device 2 of 2.Reference mfr.Report: 3006705815-2018-00815.Follow-up identified the physician was unsure if the symptom of double vision was related to the csf leak.
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Search Alerts/Recalls
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