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 Problems
Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/21/2022 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced partial electrode insertion at initial implant surgery.The recipient experienced sound quality issues.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 implant.Imaging confirmed full insertion.
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Manufacturer Narrative
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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 recipient's device is reportedly lost and will not return to advanced bionics 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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