ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD
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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 (1880)
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Event Date 06/02/2021 |
Event Type
Injury
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Event Description
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Related manufacturer report number: 3006705815-2021-03273.It was reported the patient had a headache post-operatively.As a result, the patient went to the emergency room where they were released after given iv fluids.Two blood patches were performed, but the issue did not improve, as a result, a ct myelogram is anticipated.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Search Alerts/Recalls
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