Model Number CI-1601-04 |
Device Problems
Loose or Intermittent Connection (1371); Patient Device Interaction Problem (4001)
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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 Type
Injury
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Event Description
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The recipient is reportedly experiencing retention issues.The recipient will undergo a skin flap thinning surgery.
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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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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 used.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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Manufacturer Narrative
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The recipient is reportedly experiencing some crusting which is preventing the recipient from using device.The recipient continues to have retention issues.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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