Model Number CI-1601-05 |
Device Problems
Insufficient Information (3190); Noise, Audible (3273)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 12/09/2020 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing loudness growth issues.Programming adjustments were made, however, the issue did not resolve.The recipient is a poor performer.Revision surgery is scheduled.
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Manufacturer Narrative
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The recipient's device was reportedly explanted.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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The recipient¿s device was reportedly discarded and will not return to advanced bionics for analysis.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.A review of the device history record was completed and no anomalies were noted.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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