Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Swelling (2091); Post Operative Wound Infection (2446)
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Event Date 06/29/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Manufacturer¿s evaluation: the complaint of infection cannot be confirmed 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.(b)(4).
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Event Description
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It was reported the patient experienced fever, chills and swelling at the lead incision site.The physician suspected an infection; however, cultures tested negative.No additional information is known 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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Follow-up identified the issue has resolved.
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Search Alerts/Recalls
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