The company was informed that the patient had an infection at the implant site following a head injury.The area was cleaned and a skin flap was placed; however, the recipient manipulated the surgical scar, preventing the healing of the stitches and leading to device extrusion.The recipient's device was explanted.The recipient was not reimplanted.The recipient is doing well.
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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed tool damage to the top cover overmold, as well as a severed electrode.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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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