Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950); Insufficient Information (3190)
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Patient Problems
Therapeutic Response, Decreased (2271); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/08/2021 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance.A review of the recipient¿s test data indicated impedance issues.Programming adjustments were made.Revision surgery is being considered.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient will reportedly not pursue revision surgery at this time.The recipient is wearing the device.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 recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.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.Advanced bionics received permission on behalf of the recipient to proceed with failure analysis on june 20, 2022.The explanted device was received at the company on august 4, 2021 and underwent analysis.The external visual inspection revealed sliced silicone overmold on the top and bottom covers, as well as a severed electrode.These anomalies are believed to have occurred during revision surgery.The photographic imaging inspection revealed an electrode was broken within the electrode pocket.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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Search Alerts/Recalls
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