Model Number 408719 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Swelling (2091)
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Event Date 10/03/2019 |
Event Type
Injury
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Event Description
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Patient presented with bleeding and swelling localized to the device pocket.Infection was noted as a potential cause, but this has not been confirmed.It was reported that pocket revision was scheduled for (b)(6) 2019, but no further information has been received.No information regarding revision or explant has been provided.Should additional information become available, this file will be updated.
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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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Manufacturer Narrative
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(b)(6) 2020 - it was reported that this system was explanted on (b)(6) 2020.There is currently no indication that a new system has been implanted.Should additional information be received, this file will be updated.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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