Model Number 3086 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Cerebrospinal Fluid Leakage (1772)
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Event Date 04/17/2018 |
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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Device 1 of 2.Reference mfr report#3006705815-2018-01131.It was reported cerebrospinal fluid (csf) leak occurred during scs trial procedure on (b)(6) 2018.As a result, the physician abandoned the implant procedure.Reportedly, patient had no symptoms.No interventions were performed.Patient information is unknown at this time.
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Event Description
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Device 1 of 2.Reference mfr report#3006705815-2018-01131.Additional information identified that cerebrospinal fluid (csf) leak cleared.
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Search Alerts/Recalls
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