Model Number 3086 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); Nausea (1970); Headache, Lumbar Puncture (2186)
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Event Date 12/05/2014 |
Event Type
Injury
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Event Description
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It was reported during the trial procedure, while attempting to place the first trial lead the physician punctured the dura causing a small csf leak.The trial lead was removed and the procedure aborted.A blood patch was not performed.The patient experienced a headache and nausea and remained in the recovery room for a few hours to recover.
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Event Description
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Follow up information identified the patient's headache and nausea resolved.A blood patch was not necessary.
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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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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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Search Alerts/Recalls
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