Catalog Number 500101 |
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 Type
Death
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Manufacturer Narrative
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Patient death due to multi-system organ failure as a complication of existing medical conditions.Device confirmed by hospital staff to not have cause 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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A syncardia approved supplier has reported the death of a patient due to multi-system organ failure.Patient was on support device for one day.No autopsy was performed and the device was not explanted.According to the report from the patient's doctor, the device did not cause or contribute to the patient's death.
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Search Alerts/Recalls
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