Model Number 3186 |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/08/2017 |
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# 1627487-2017-06599.It was reported (australia) during the lead revision procedure (reference mfr.Report# 1627487-2017-06695) the physician was unable to advance the leads to the intended position due to the patient¿s anatomy.As a result, the physician abandoned the procedure and the scs system was explanted.
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Event Description
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Device 2 of 2, reference mfr.Report# 1627487-2017-06599.
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Search Alerts/Recalls
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