It was reported that the device shows the eri status.The icd is scheduled to be explanted.Please note this icd is affected by a field safety corrective action, bio-lqc, initiated in march 2021.No adverse patient events were reported.Should additional information be received, this file will be update.
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The device was received and analyzed.Explant date is currently unknown.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were reviewed.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.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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