Product event summary: the controller with an unknown serial number was not returned for evaluation.Log file analysis could not be performed since log files covering the reported event date were not available for analysis.As a result, the reported event could not be confirmed.Based on the limited information available, there is no evidence to suggest that a device malfunction caused or contributed to the reported event.This event was reported in the q1 2021 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.If information is provided in the future, a supplemental report will be issued.
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