Model Number 429522 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Drug Resistant Bacterial Infection (4553)
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Event Date 08/22/2023 |
Event Type
Injury
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Manufacturer Narrative
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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 summary, the infection was not device related.
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Event Description
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The patient suffered from a mrsa crt-d pocket infection.The patient was hospitalized.Crt-d and all leads were removed.Drug therapies were changed.Negative pressure wound therapy was done.
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Manufacturer Narrative
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It was reported that circulatory failure was seen.This resulted in worsening heart failure.The patient died due to sustained ventricular tachycardia in the hospital.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 summary, the infection was not device related.
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Search Alerts/Recalls
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