Model Number 3228 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nausea (1970); Vomiting (2144)
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Event Date 06/15/2016 |
Event Type
Injury
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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.(b)(4).
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Event Description
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It was reported the patient experiences nausea and vomiting when using stimulation from his scs system.Subsequently, the patient will undergo surgical intervention to address the issue.
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Event Description
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Follow-up information revealed the patient underwent surgical intervention on (b)(6) 2016, at which the scs system was explanted.
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Search Alerts/Recalls
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