Model Number 404629 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Endocarditis (1834)
|
Event Date 01/28/2021 |
Event Type
Injury
|
Event Description
|
It was reported that this system was explanted due to endocarditis.Should additional information become available, this file will be updated.
|
|
Manufacturer Narrative
|
An endocarditis 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 endocarditis was not device related.
|
|
Manufacturer Narrative
|
The method, result, and conclusion codes remain the same as follow up one.An endocarditis 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 endocarditis was not device related.
|
|
Search Alerts/Recalls
|
|