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.Upper housing body and frontplate were mechanically damaged.The device underwent 48h long time testing in temperature cycling cabinet.No missing beat has been detected.The evaluation did not raise any function defect causing stimulation problems.The failure description could not be reproduced.Except the housing damaged the pacemaker works according to its specification.Possible causes for stimulation failures could be: damaged extension or adapter cable (was not returned for evaluation), bad lead to tissue contact, inappropriate lead position, connection problem between lead wire to patient extension cable or extension cable to pacemaker, not correct adjustment of capture threshold due to wrong stimulation amplitude setting.Unfortunately there were no further details of the circumstances available which could explain the most likely root cause.The damaged housing parts have been replaced and after completed safety and functional test the device was returned to the importer on (b)(6) 2019.
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