This patient had an infection, but the physician didnknow the source of the infection.The day after explant, the patient expired due to complications not related to the system.This is all of the information that was provided to us.Should additional information become available, this event will be updated.
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An infection was observed following the implantation of this biotronik device.The sterilization process was investigated.The validated process assures that all sterilization parameters, such as gas concentration, temperature, humidity, etc., are within its specified ranges for each distributed device.Additionally an analysis of validated microbiological indicators is performed after every sterilization procedure as evidence of successful completion of the sterilization process.Review of the biotronik complaint database did not reveal any changes regarding the trend for this type of incident.In conclusion, the infection was not device related.
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