Model Number CI-1601-04 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950)
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Patient Problem
Failure of Implant (1924)
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Event Date 05/06/2021 |
Event Type
malfunction
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Event Description
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A review of the recipient¿s test data indicated impedance issues.Revision surgery is scheduled.
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Manufacturer Narrative
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The recipient's device was reportedly explanted.The recipient was re-implanted 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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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed cuts to the top cover and fantail revision.In addition, the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed cut electrode wires in the fantail.This is believed to have occurred during revision surgery.System lock was verified.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 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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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.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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Search Alerts/Recalls
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