Model Number 3186 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)
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Event Date 08/31/2017 |
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 1 of 2.Reference mfr.Report# 1627487-2017-05315.It was reported (b)(6) during the trial lead placement procedure following sedation the patient desaturated and the blood pressure plummeted.The patient was turned back into supine position.The patient was intubated and general anesthesia was provided.The leads were placed as intended.No product was involved in the issue.
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Event Description
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Device 1 of 2, reference mfr.Report# 1627487-2017-05315.Additional information received identified the patient is in stable condition.
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Search Alerts/Recalls
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