Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Purulent Discharge (1812); Post Operative Wound Infection (2446)
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Event Date 01/05/2016 |
Event Type
Injury
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Manufacturer Narrative
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The complaint of infection cannot be confirmed via laboratory testing.(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.(b)(4).
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Event Description
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It was reported the patient had signs of infection at the lead incision site.Green pus was noted.As a result, the patient will undergo surgical intervention.
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Event Description
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Follow-up revealed the patient's scs system was explanted on (b)(6) 2016.The patient has completed oral antibiotics and the infection has resolved over time.
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Search Alerts/Recalls
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