Model Number CI-1500-04 |
Device Problems
Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Unspecified Infection (1930)
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Event Date 10/29/2022 |
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 reportedly experienced device migration following a head trauma.In (b)(6) 2022, the recipient's device was repositioned.In (b)(6) 2022, the recipient experience another head trauma which resulted in device extrusion.The recipient's device was repositioned, however the issue did not resolve due to a loss of tissue and infection.The recipient's device was ultimately explanted.The recipient was not reimplanted.
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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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The recipient was reimplanted with another advanced bionics cochlear device on (b)(6), 2023.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 sliced silicone on the top and bottom covers, as well as a severed electrode.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.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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