ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE TRIAL LEAD KIT, 60CM LENGTH; SCS LEAD
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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 06/28/2018 |
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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It was reported that there was a cerebrospinal fluid leak that occurred during an trial implant procedure for the patient.It was also reported that the patient was experiencing a severe headache post-op.As a result, a blood patch was performed to address the issue.
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Search Alerts/Recalls
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