Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950); Output below Specifications (3004)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 09/30/2020 |
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.
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Manufacturer Narrative
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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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The recipient was reimplanted with another 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 device passed the external visual inspection.The photographic imaging inspection revealed an electrode was broken within the electrode pocket.System lock was verified.The device passed the electrical tests performed.Advanced electrical testing performed on the device showed 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 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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