Model Number CI-1600-04 |
Device Problems
Expulsion (2933); Material Protrusion/Extrusion (2979)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/21/2020 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing electrode extrusion, open circuits, and sound quality issues.The recipient is a poor performer.Revision surgery is scheduled.
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Manufacturer Narrative
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The recipient's device was reportedly explanted.The recipient was re-implanted with another advanced bionics cochlear device.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 slices silicone at the fantail and the electrode was severed near the array prior to receipt.These are believed to have occurred during revision surgery.The device passed the 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 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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