Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.Next, the device was interrogated.The interrogation could be properly performed and revealed the eri battery status, confirming the clinical observation.Next, the icd was subjected to an analysis of the electrical parameters.The current consumption of the icd was checked and found to be normal and as expected.Analysis of the battery condition, however, showed an inconsistency of charge taken from the battery and the battery voltage.A premature battery depletion could be confirmed during analysis.Please note, this icd is affected by the field safety corrective action, bio-lqc, initiated in march 2021.
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