Model Number 3086 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); Post Operative Wound Infection (2446)
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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.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.Manufacturer 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# 3006705815-2018-01368.It was reported the physician noticed fluid at the lead site when pulling the patient¿s trial leads.The physician sent the patient home with instructions to monitor the site closely.The patient returned the same day with a headache and additional fluid present at the lead site.The physician admitted the patient to the hospital, a blood patch was administered along with iv antibiotics for three days.Cultures were unremarkable, and the patient was discharged on (b)(6) 2018 without any residual symptoms.
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Manufacturer Narrative
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The reported event cannot be analyzed via laboratory testing.
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Event Description
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Device 1 of 2.Reference mfr.Report# 3006705815-2018-01368.
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Search Alerts/Recalls
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