Model Number CI-1600-04 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/15/2023 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced overly loud sound.External equipment was exchanged and 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 device.
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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 no longer considers this event reportable.Please refer to mdr # 3006556115-2023-01990 for additional reporting.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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