Model Number CI-1600-05 |
Device Problem
Output below Specifications (3004)
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Patient Problem
No Information (3190)
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Event Date 08/06/2020 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing decreased performance and facial stimulation.Programming adjustments were made, however, the issue did not resolve.The recipient wears the device inconsistently.Revision surgery will be scheduled.
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Manufacturer Narrative
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The recipient's device was reportedly explanted.The recipient was reimplanted with another advanced bionics 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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Revision surgery is reportedly scheduled.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 and photographic imaging inspections.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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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