The device was not returned for analysis.The analysis is thus based on the inspection of the quality documents associated with the manufacture of this particular device as well as the data returned for evaluation.The manufacturing process for this device was reviewed and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the device functions to be as specified.In a next step, the returned device data was inspected.During the inspection the clinical observation could be confirmed.Further analysis revealed an unexpected battery behavior, which led to the clinical observation.Based on the data available for analysis the root cause for that behavior was not determinable and can only be clarified by an analysis of the device itself.However, it cannot be excluded that this occurrence resulted from a defective component, which may compromise the ability of the device to deliver therapy.Should further relevant information or the device itself become available this investigation will be updated.
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