Model Number CI-1601-05 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/23/2021 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing electrode migration.A ct scan revealed the electrode array outside of the cochlea.Programming adjustments were made, however, the issue did not resolve.Revision surgery is scheduled.
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Manufacturer Narrative
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The recipient's device was reportedly 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 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 device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This version of the ultra 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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