Model Number CI-1601-05 |
Device Problems
Migration or Expulsion of Device (1395); 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 12/03/2021 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing electrode migration.A ct scan revealed electrode contacts outside of the cochlea.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 damage to the top cover, as well as a severed electrode.These are 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 tests performed.The device passed the mechanical test performed.This device was explanted for medical reasons.The device passed the tests performed.This version of the hires ultra device is no longer distributed.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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