Model Number CI-1500-01 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/24/2020 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced a partial electrode insertion due to severe malformation of the cochlea.On (b)(6) 2020, the recipient underwent repair surgery and the recipient's device was explanted.The recipient recovered.
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Manufacturer Narrative
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Additional information: section d.10: 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 was not reimplanted.The device passed the external visual and photographic imaging inspections.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 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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