Model Number 3086 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Fever (1858); Pain (1994)
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Event Date 03/12/2017 |
Event Type
Injury
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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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Device 2 of 2.Reference mfr.Report#3006705815-2017-00349.It was reported the patient underwent an scs trial on (b)(6) 2017.Subsequently, the patient was admitted to the er on (b)(6) 2017 with fever, pain at the lead site and a suspected infection.As such, the patient was treated with antibiotics and reportedly discharged 2 days later.
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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.
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Event Description
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Device 2 of 2.Reference mfr.Report# 3006705815-2017-00349.Follow-up identified a staph infection was confirmed.Furthermore, the patient is receiving continuous iv antibiotic therapy as treatment.
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Search Alerts/Recalls
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