Upon receipt, the icd was interrogated, revealing the battery status bos.The icd was implanted for approximately 26 months and four charging cycles were recorded to the device memory.The memory content of the icd was inspected.The inspection revealed an elevated charge time, confirming the clinical observation.Therefore, the device was opened to inspect the inner assembly and to check the functionality of the electronic module.The inspection revealed that one high voltage capacitor was damaged.This damage led to an elevated leakage current of that capacitor, causing a prolonged charge time as mentioned in the complaint description.In addition, the manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process which may be related to the clinical observation.Particularly the final acceptance test proved the device functions to be as specified.In conclusion, the clinical observation resulted from a damaged high voltage capacitor.The manufacturing records document a normal device production.It is therefore assumed, that the damage occurred after the device shipment, however the date of occurrence was not determinable.
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