Model Number CI-1400-01 |
Device Problems
No Audible Prompt/Feedback (2282); 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 08/05/2021 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced sound quality issues.External equipment was exchanged, however, the issue did not resolve.The recipient's device was explanted.
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Manufacturer Narrative
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The recipient was reimplanted with another advanced bionics cochlear device.The recipient is doing well.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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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 external visual inspection revealed the electrode was cut prior to receipt.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The condition of the electrode prevented and electrical test from being performed.The device passed the electrical and mechanical tests performed.The reported complaint of sound quality could not be verified during this analysis, which was limited in some respects due to the electrode being severed prior to receipt.This device passed all of the tests performed.This version of the hires 90k device is no longer distributed.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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