Model Number MN10350-50A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); Dyspnea (1816); Headache (1880)
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Event Date 10/06/2019 |
Event Type
Injury
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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Related manufacturer reference number: 1627487-2019-11976.It was reported the patient experienced headaches and trouble breathing due to a csf leak following implant of trial leads.As a result the leads were explanted on an unknown date and a blood patch was performed.Symptoms have resolved.
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Manufacturer Narrative
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Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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Related manufacturer reference number: 1627487-2019-11976.
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Search Alerts/Recalls
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