Model Number CI-1601-05 |
Device Problems
Migration or Expulsion of Device (1395); Expulsion (2933)
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Patient Problems
Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 10/12/2022 |
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 is reportedly experiencing poor performance and device extrusion.Advanced bionics is still in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.
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Manufacturer Narrative
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The recipient underwent repositioning surgery on (b)(6) 2022.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 has reportedly healed and resumed device use.No further 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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