Known high impedance lv ring to can, artifacts on lv iegm, hence lv sensing turned off and programmed lv output lv1 to can.Now also impedance in that configuration lv1 to can occasional >2000.Lead currently remains implanted.Should additional information be received, this file will be updated.
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As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The analysis is thus based on the inspection of the manufacturing documents of the device as well as on the provided data.The quality documents accompanying the manufacturing process for this device were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.The analysis of the provided trend data, acquired between 13th of june 2023 and 12th of july 2023 recorded a fluctuating pacing impedance between 600 ohms and 700 ohms.The analysis of the provided iegm test episodes revealed artifacts on the lv channel.In spite of the available information, no conclusion can be drawn regarding the root cause of the clinical observation.An analysis of the lead itself would be necessary to determine the root cause.Should additional information or the device itself become available for analysis, the investigation will be updated.
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