Related manufacturer reference number: 1627487-2024-07791 related manufacturer reference number: 1627487-2024-07826 it was reported that patient experienced an infection, location of infection is unknown.As a result, surgical intervention was undertaken on an unknown date wherein patients system was explanted and patient was hospitalized to address the issue.
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A patient had their system explanted due to infection was reported to abbott.The patient was hospitalized to address the issue.As a result, a device history record was performed to review and confirm the sterility of devices.Based on the documents reviewed, the source of the infection remains unknown.The results of the investigation are inconclusive based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.
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