The device involved in this mdr report is not approved in the united states; however, it is similar to a device manufactured by microport crm that was cleared or approved by fda for marketing in the united states.Investigation outcome: review of provided files confirmed the reported behavior for all three cases: o the last saved lv auto threshold results displayed on the overview screen are not the last measurements performed by the algorithm there is an incoherence in the programming of lv auto threshold and pacing configuration.Pacing configuration is based on v3 vector, whereas lv auto threshold is programmed on lv vector.On the overview screen, the last stored result of lv auto threshold on v3 vector is expect (because of the programming).Due to a known software bug the lv auto threshold on v3 vector is programmed to off, so no automatic update is possible.The episodes and curves from lv auto threshold are coming from test on lv vector (which is programmed to monitor), so based on lv vector.The observed behavior is the result of a known software bug which could occur under the following conditions: following programming is requested by the user: o multipoint lv pacing = off o lv pacing polarity programmed with a ¿v3 pacing chain¿ vector (one of the 6 following configurations: lv3-can, lv3-lv4, lv3-lv2, lv3-rvcoil, lv3-rvring, lv4-rvcoil) o lv autothreshold switched from off to auto or monitor the programmer programs lv autothreshold as followed: o off on the programmed pacing polarity = the one on ¿v3 pacing chain¿ o auto (resp.Monitor) on a ¿lv pacing chain¿ vector (one of the 8 following configurations: lv1-can, lv1-lv2, lv1-rvcoil, lv1-lv4, lv1-rvring, lv2-can, lv2-rvcoil, lv2-lv4) o the one selected is the last which was programmed (note that as-shipped/default value is lv1-lv2) a software fix is under assessment by microport crm.
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