Catalog Number 570500-001 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/27/2023 |
Event Type
Death
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Manufacturer Narrative
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Patient death due to multiple system organ failure as a complication of existing medical conditions.Device confirmed by hospital staff to not have caused or contributed to patient death.Device was not explanted and no autopsy was performed.Syncardia has completed its evaluation and is closing this file.If new or additional information is received in the future, syncardia will file a follow-up mdr.
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Event Description
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Patient death due to multi-system organ failure on (b)(6) 2023 after 48 days on support.No autopsy was performed, the device was not explanted, and the staff indicated on the outcome form that the device did not cause or contribute to the patient's death.
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Search Alerts/Recalls
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