Model Number CI-1601-04 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950); Output below Specifications (3004); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/22/2021 |
Event Type
malfunction
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Event Description
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The recipient reportedly experienced decreased performance.A review of the recipient¿s test data indicated impedance issues.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.Legal proceedings have prohibited the testing and failure analysis of the explanted device.As a result, no conclusion can be drawn at this time.If the legal proceedings allow for the analysis to be completed, the issue will be re-opened and the results of the analysis will be reported.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.The device passed the external visual inspection.The photographic imaging inspection revealed some electrodes were broken within the electrode pocket.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 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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Search Alerts/Recalls
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