Model Number 3660 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Swelling (2091); Skin Inflammation (2443)
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Event Date 09/14/2017 |
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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It was reported the patient experienced pain, redness, and swelling at the ipg site.As such, an immediate physician consult was advised as the next course of action.Follow-up identified surgical intervention may be undertaken at a future date.
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Event Description
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Follow-up identified surgery took place on (b)(6) 2017 wherein the ipg was repositioned inside the pocket.Reportedly, no swelling, redness, or infection were noted.Cultures were normal.
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Search Alerts/Recalls
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