This report is related to initial report from importer (b)(4) with importer report # (b)(4).The device was returned to manufacturer, and arrived on 28oct2019.Initial evaluation did not show any functional problem.The perspex protection cover was missing.Later intensive evaluation did not raise any function defect causing sensing problems.The failure description could not be reproduced.The pacemaker works according to its specification.Possible causes for sensing failures could be: bad lead to tissue contact; inappropriate lead position; not correct adjustment of sensitivity threshold causing undersensing due to wrong sensitivity setting to hight sensitivity values.Unfortunately, there were no further details of the circumstances available, which could explain the most likely root cause.The missing prespex cover has been replaced and the device has passed safety and functional test, and returned to the importer on 05dec2019.
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