Model Number CI-1601-05 |
Device Problems
Migration or Expulsion of Device (1395); No Audible Prompt/Feedback (2282); Migration (4003)
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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 10/14/2021 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing electrode migration and no sound.Imaging confirmed electrode migration.Revision surgery has been scheduled.
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Manufacturer Narrative
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The recipient's device was explanted.The recipient was reimplanted 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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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed tool marks on the antenna and the top cover.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 tests performed.The residual gas analysis test was compromised and data could not be collected.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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