Model Number CI-1601-04 |
Device Problems
Mechanical Problem (1384); Output below Specifications (3004)
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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 01/11/2021 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance.Programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.
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Manufacturer Narrative
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Additional information: sections b.3 & d.6b.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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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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