Model Number 3086 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hypoxia (1918); Tachycardia (2095)
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Event Date 02/13/2018 |
Event Type
Injury
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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.The manufacturer 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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It was reported the patient was to undergo a trial procedure and when the patient was placed prone and sedated the patient became hypoxic and tachycardic.The procedure was abandoned.The patient was oxygenated and stabilized.No products were opened or implanted.
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Event Description
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Device #1 of 2: reference mfr.Report: 3006705815-2018-00475.Follow up information identified the patient stabilized and was able to undergo the trial procedure on that same day (b)(6) 2018.The trial was successful.The patient was not hospitalized.Device information has been added.
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Search Alerts/Recalls
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