Related manufacturer reference number: 1627487-2023-06059, related manufacturer reference number: 1627487-2023-06060, related manufacturer reference number: 1627487-2023-06062, related manufacturer reference number: 1627487-2023-06063.It was reported that patient experienced infection at ipg and extension sites, and there is a possible infection at the lead site.As a result.Surgical intervention was undertaken on (b)(6) 2023 wherein ipg and extensions were explanted to address the issue.Patient was administered oral antibiotics and hospitalized post-op to address the issue.Additional surgical intervention may be undertaken to address the possible infection of the leads.
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A patient experienced infection at ipg and extension sites, and there is a possible infection at the lead site was reported to abbott.The ipg and extensions were explanted to address the issue.Patient was administered oral antibiotics and hospitalized post-op 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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