Upon receipt, the programmer and monitoring device including the programming head and the renamic psa module was inspected.Apart from signs of usage no deviation was found related to the clinical observation during analysis.Further analysis including an intensive long term investigation of the psa pacing and sensing functions under mechanical stress did not reveal any indication of a device malfunction.In particular the rv channel was observed, but no anomaly could be found.The described behavior possibly could have been observed in a configuration where lv sensing was active while the lv lead was disconnected.In that case interferences from electromagnetic fields might have been detected as lv sense signals and depending on the chosen pacing program might have caused the inhibition of the rv channel.So external influences may have led to the observed behavior.It does not represent a device malfunction.The visual, mechanical and functional analysis revealed no indication of a material or manufacturing problem.
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