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Model Number CI-1601-05 |
Device Problems
Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/22/2022 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced partial insertion and open electrodes.The recipient underwent repositioning surgery, however, the open electrodes 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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Advanced bionics considers the investigation into this reportable event as closed.The recipient is reportedly doing well.The recipient's device was reportedly discarded and will not be returned for analysis.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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