Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed tool damaged on the brazed area.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at any spacing.This is due to the damage that is believed to have been induced during revision surgery.The manual capacitor leakage test revealed unstable readings due to flooded components.This is due to the damage that is believed to have been induced during revision surgery.This device was explanted for medical reasons.However, testing was limited due to the damage induced prior to receipt.This older device configuration is not currently manufactured.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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