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, Lumbar Puncture (2186)
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Event Date 12/09/2016 |
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#: 1627487-2017-00063.It was reported the patient underwent a trial procedure on (b)(6) 2016 and was implanted with two leads.During the procedure, the patient experienced a cerebrospinal fluid leak.In turn, the patient experienced a headache following the procedure later that date.As a result, the patient's leads were removed and a blood patch was performed.
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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#: 1627487-2017-00063.Follow-up revealed the patient's issue has resolved.
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Search Alerts/Recalls
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