Model Number CI-1400-01 |
Device Problem
Migration (4003)
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Patient Problem
Edema (1820)
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Event Date 01/03/2020 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced electrode migration.The recipient underwent repositioning surgery, however, during surgery an edema was identified in the middle ear and the device was explanted.The recipient was not reimplanted.
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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 that the electrode was severed prior to receipt.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 is the final report.
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Manufacturer Narrative
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The recipient reportedly recovered.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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