Model Number CI-1600-04 |
Device Problems
Impedance Problem (2950); Insufficient Information (3190)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 10/13/2020 |
Event Type
malfunction
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Event Description
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The recipient reportedly experienced impedance issues and decreased performance.Programming adjustments were made, however, the issue did not resolve.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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Due diligence attempts to obtain additional details regarding device return were unsuccessful.The recipient¿s device 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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