Model Number 3186 |
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 05/02/2018 |
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: 1627487-2018-04860.It was reported that patient experienced a csf leak while undergoing a lead revision surgery on (b)(6) 2018.A blood patch was performed and patient has reported no symptoms.
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Manufacturer Narrative
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Further follow up revealed that csf leak happened while the two new leads were implanted and not on explant of old leads as previously reported.The two new leads have been added to this record.
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Event Description
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Device 1 of 4, reference mfr report: 1627487-2018-04860, 3006705815-2018-01216, 3006705815-2018-01217.Further follow up revealed that csf leak happened while the two new leads were implanted and not on explant of old leads as previously reported.The two new leads have been added to this record.
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Search Alerts/Recalls
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