Model Number CI-1601-05 |
Device Problems
Migration or Expulsion of Device (1395); Output below Specifications (3004); Appropriate Term/Code Not Available (3191); Migration (4003)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/16/2022 |
Event Type
Injury
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Manufacturer Narrative
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Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
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Event Description
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The recipient reportedly experienced poor performance and electrode migration.Repositioning surgery took place on (b)(6) 2022.
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Manufacturer Narrative
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Additional information: section d.6b.Advanced bionics considers the investigation into this reportable event as closed.The recipient has reportedly healed from surgery and has resumed device use.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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