The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.On (b)(6) 2018, it was reported that the patient had a rapid increase in lactate dehydrogenase to 800 u/l with concern for pump thrombosis.On (b)(6) 2018, the patient¿s inr was 4.1.No clinical symptoms were reported.A log file was submitted for review.The manufacturer¿s technical services reviewed the provided log file which contained data from (b)(6) 2018 and observed some unsustained power and flow elevations.No other unusual events were seen within the event history and the pump appeared to be functioning as intended.Additional information was requested but not yet provided.
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