Additional information: sections b3, d7, & d10.The recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics cochlear device.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 external visual inspection revealed silicone damage on the top and bottom covers, slices at the fantail, and the electrode was severed near the array prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection revealed a broken electrode within the electrode pocket.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical tests performed.Advanced electrical testing performed on the device revealed lower than typical range on some of the electrodes.It is the opinion of advanced bionics explant review board that some of these electrode test results should be considered as failures.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 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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