It was reported that on (b)(6) 2022, a 23mm masters series valve was successfully implanted.On (b)(6) 2022, a temporary pacemaker was implanted.Post-operatively on (b)(6) 2022, a junctional rhythm was observed, which resolved on (b)(6) 2022 with evolution in sinus rhythm with right bundle branch block (rbbb) and ventricular ectopics.The patient does not have a past medical history of this type of arrhythmia, but he has a history of 2 episodes of atrial fibrillation in 2012.This event caused a prolonged hospitalization.The patient underwent observation and several arrhythmia consultancies which did not indicate arrhythmia therapy was required.No medical or surgical intervention was given.There was no allegation of malfunction against the abbott device.The cause of the arrhythmia and subsequent rbbb was not possible to define.There were no other adverse patient effects or symptoms.
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An event of junctional rhythm, right bundle branch block, and ventricular ectopics was reported.A returned device assessment could not be performed, as the device remains implanted.And was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.And the product met all specifications.
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