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); Vomiting (2144)
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Event Date 10/29/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Sjm 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.Sjm defers to the patient's physician regarding medical history.
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Event Description
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Device 1 of 2.Reference mfr.Report# 1627487-2015-20646.It was reported the patient experienced headache and vomiting due to csf leak (physician believed) after the scs trial procedure.The patient was taken to the er.The physician performed a blood patch.The trial was ended on the expected date.
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Manufacturer Narrative
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Sjm 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.Sjm defers to the patient's physician regarding medical history.
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Event Description
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Device 1 of 2.Reference mfr.Report# 1627487-2015-20646.Further follow up identified the issue of headache resolved with the blood patch.
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Search Alerts/Recalls
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