Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed cuts in the silicone overmold on the top and bottom covers and along the electrode lead, 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 some of the electrical tests performed.The device passed the mechanical test performed.The failure of this device is attributed to an electrode short in the electrode pocket.A corrective action was implemented.This version of the hires ultra device is no longer distributed.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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Advanced bionics considers the investigation into this reportable event as closed.The determination of the root cause for device migration cannot be determined as it could involve: recipient anatomy, cochlear environment, surgical technique, trauma to the recipient, etc.The external visual inspection revealed cuts in the silicone overmold on the top and bottom covers and along the electrode lead, 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 some of the electrical tests performed.The device passed the mechanical test performed.Additionally, further device failure analysis determined that this device also contained an electrode short in the electrode pocket, but this was not the reason for explant.Advanced bionics will also categorize this explant as a device failure and therefore we have classified it as such for our risk analysis purposes.A corrective action was implemented.This version of the hires ultra device is no longer distributed.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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