Model Number MN10450-90A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pulmonary Embolism (1498); Death (1802)
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Event Date 12/02/2019 |
Event Type
Death
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Manufacturer Narrative
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Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Related manufacturer reference number: 1627487-2019-14185.Related manufacturer reference number: 1627487-2019-14210.It was reported that the patient experienced an pulmonary embolism post system implant on (b)(6) 2019.Next course of action is undetermined at this time.
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Event Description
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It was reported that the patient was undergoing surgical intervention to have a stent placed due to congestive heart failure.The patient passed away on (b)(6) 2019 as a result of cardiac issues.
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Manufacturer Narrative
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Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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Search Alerts/Recalls
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