Related manufacturer reference number: 3006705815-2023-00639, 3006705815-2023-00640, 3006705815-2023-00641, 1627487-2023-00479.It was reported that patient had an infection at ipg and both lead sites.The patient experienced fever and pain.Laboratory tests/cultures were taken; however, the results are unknown.Antibiotics were prescribed and patient was hospitalized.Surgical intervention was undertaken wherein the patient underwent an emergency system explant.
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Device history record was performed to review and confirm the sterility of devices.A review of the lot history record identified no manufacturing nonconformities issued to the reported device that would have contributed to this event.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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