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Model Number CI-1600-05 |
Device Problems
Expulsion (2933); Material Protrusion/Extrusion (2979); Output Problem (3005)
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Patient Problems
Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/04/2021 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced electrode extrusion.The recipient underwent repositioning surgery in (b)(6) 2021.The recipient is experiencing possible electrode extrusion once again.The recipient is presenting with sound quality issues.Programming adjustments were made, however, the issue did not resolve.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.Programming adjustments were made and the recipient continues to use the device.No further treatment details will be provided.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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