Noise detected through remote monitoring as a vf episode, likely lead fracture, no inappropriate shocks delivered.Hv impedance out of range.Icd system (lead and device) was replaced, old lead capped and left in situ (inactive).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 15th of december 2023 and 13th of march 2024 recorded an initial stable shock impedance of 100 ohms with a sudden increase to >150 ohms in january 2024 until the end of the recording period.The analysis of the provided iegm episodes revealed artifacts on the atrial, rv and far-field channel, which led to the reported oversensing as well as icd charging cycles.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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