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, Lumbar Puncture (2186)
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Event Date 12/05/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Sjm 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.Sjm defers to the patient's physician regarding medical history.(b)(4).
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Event Description
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Device 1 of 2.Reference mfr.Report# 1627487-2017-00056.It was reported the patient ((b)(6)) experienced csf leak due to dural puncture while implanting the trial leads.As a result, the patient experienced new pain in her buttocks radiating down to the legs and headache.No additional information available at this time.
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Manufacturer Narrative
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Sjm 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.Sjm 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# 1627487-2017-00056.Additional information received identified the patient was hospitalized due to the issue.The trial leads were explanted on (b)(6) 2016 (as intended).As of (b)(6) 2017 the patient is asymptomatic thus the issue resolved.
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Manufacturer Narrative
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The reported event cannot be analyzed via laboratory testing.Sjm 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.Sjm 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# 1627487-2017-00056,.
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Search Alerts/Recalls
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