Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994)
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Event Date 05/08/2015 |
Event Type
Injury
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Event Description
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It was reported the patient was scheduled for a debridement procedure to clean out the patient's scs lead surgical incision site.Follow-up identified the irrigation/debridement procedure was done on (b)(6) 2015.In addition, the patient's family stated the incision looked fine after the procedure.
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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.
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Event Description
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Additional information received identified the patient had his scs system removed approximately eight months ago (exact date unknown) due to infection.Additionally, the patient has recovered completely.
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Search Alerts/Recalls
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