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 Type
Injury
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Event Description
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The recipient is reportedly experiencing electrode migration and open electrodes.A ct scan confirmed electrode migration.Repositioning surgery is scheduled.
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Manufacturer Narrative
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The recipient underwent repositioning surgery on (b)(6) 2022.The recipient reportedly has scar tissue in the mastoid.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 recipient's device was successfully activated.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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