Model Number CI-1400-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Tinnitus (2103); Dizziness (2194); Discomfort (2330)
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Event Date 11/14/2023 |
Event Type
Injury
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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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Event Description
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The recipient is reportedly experiencing tinnitus, dizziness, and pain with and without device use.Ct scan revealed unremarkable results.Programming adjustments have been made; however, the issue did not resolve.The recipient is reportedly a non-user.Revision surgery has been scheduled.
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Manufacturer Narrative
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The recipient's device was explanted.The recipient was not reimplanted.The recipient is healing 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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Advanced bionic considers the investigation into this reportable event as closed.The external visual inspection revealed silicone damage on the top and bottom cover of the device.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This older device configuration is not currently manufactured.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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