The recipient reportedly experienced a head trauma in the summer of 2020.The recipient is presenting with swelling.The recipient was given antibiotic injections and the swelling reduced temporarily, however, the swelling did not resolve.On (b)(6) 2021, the recipient's device was explanted.During explant surgery, the surgeon found a green substance around the magnet and discolored tissue around the implant site.The surgeon performed a biopsy on the tissue and the results were negative for any bacteria or infection.The recipient was given arithromax for 10 days post surgery.The recipient will be reimplanted once healing is complete.
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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed cuts in the silicone on the top and bottom cover and also that the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed broken antenna coils.System lock could not be obtained at any spacing.The device passed some of the electrical tests performed.The device failed the residual gas analysis test.This device was explanted for medical reasons.However, this device had broken antenna coil wires.In addition, this device had moisture that exceeded the residual gas analysis test limit.The source of the problem was a feedthru hermeticity issue from one feedthru vendor.Feedthru assemblies from this vendor are no longer used.Corrective actions were implemented.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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