Model Number 3186 |
Device Problem
Charging Problem (2892)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/03/2017 |
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.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 #2 of 2: reference mfr.Report: 1627487-2017-01477.It was reported the patient underwent a permanent scs implant procedure and during the procedure the patient experienced a dural puncture while the physician was getting epidural access which resulted in a csf leak.In addition, a chest x-ray showed a mild pneumonia and the physician decided not to proceed with the procedure.Surgical intervention may be pending to proceed with further implantation of a scs system.
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Event Description
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Device #2 of 2: reference mfr.Report: 1627487-2017-01477.Follow up information identified the csf leak has resolved and the patient was referred out for a paddle lead.
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Search Alerts/Recalls
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