Model Number 3183 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vomiting (2144)
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Event Date 05/13/2016 |
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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Device #1 of 2: reference mfr.Report: 1627487-2016-02909.The patient's wife reported the patient experienced vomiting and unable to keep pain meds down following his scs trial procedure.The patient was taken to the emergency room and was admitted to the hospital for six days.The trial stimulator was turned off.The physician believes the patient suffered a reaction to the anesthesia and postoperative medications.Follow up information identified the stimulation was turned on and patient received stimulation without incident.Since the patient only trialed for 48 hours the trial was considered a failure and the leads were removed.The patient was discharged and prescribed antibiotics.
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Manufacturer Narrative
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Date of explant inadvertently not added to record.
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Event Description
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Device #1 of 2: reference mfr.Report: 1627487-2016-02909.
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Search Alerts/Recalls
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