The lead was not returned for analysis.Therefore, this report is solely based on the analysis of the icd itself as well as the inspection of the quality documents associated with the manufacturing of the lead and the icd.The manufacturing processes for these devices were re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing.Particularly the final acceptance tests proved the devices functions to be as specified.The icd was inspected in detail.Header analysis showed that the set screw of the df-1 rv channel was fully screwed in, impeding the lead to be inserted into the header bore.However, further inspection of the set screw showed screw marks, indicating that the lead had been previously properly connected.Analysis showed no anomalies.In a next step, the icd was interrogated, revealing the bos battery status.No charging cycles were recorded to the devices memory.The inspection of the memory content confirmed the clinical observation.Therefore, the impedance measurement functions of the device were tested and proved to be normal.The clinical observation could not be reproduced.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied, and the device delivered a defibrillation shock as specified, documenting a normal and expected sensing and shock delivery.In particular, the specified energy level was reached, and the shock impedance was as expected.In conclusion, the memory content as well as the therapeutic functionality of the icd were thoroughly analyzed.The analysis of the memory content confirmed the clinical observation.However, an extensive analysis of the icd proved the icd to be fully functional.All measured impedance values were normal.There was no indication of device malfunction.
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