Model Number CI-1600-04 |
Device Problems
Migration or Expulsion of Device (1395); Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Laceration(s) (1946); Skin Inflammation/ Irritation (4545)
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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 device extrusion following a skin laceration and infection.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.Additional information regarding treatment details were not provided.The recipient's infection reportedly healed.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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