Model Number 3186 |
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 04/03/2018 |
Event Type
Injury
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Manufacturer Narrative
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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.Abbott 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# 3006705815-2018-00907.The patient is implanted with two leads and the manufacturer is unable to determine which lead is liable.It was reported the patient underwent a scs implant procedure.During the procedure, cerebrospinal fluid leakage occurred when the surgeon attempted to access the patient's epidural space.The physician performed a blood patch during the surgery.The patient had to be hospitalized for headaches at a later date and the doctor performed another blood patch on (b)(6) 2018.
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Event Description
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Device 1 of 2.Reference mfr.Report# 3006705815-2018-00907: follow up information identified that over time the issue has resolved.
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Search Alerts/Recalls
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