Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); Positioning Problem (3009); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problems
Failure of Implant (1924); No Code Available (3191)
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Event Type
Injury
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Event Description
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The recipient is reportedly experiencing retention issues due to an air pocket over the implant caused by tube dilatation.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.A ct scan confirmed an air pocket.The recipient underwent surgery to remove the air pocket.
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Manufacturer Narrative
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The recipient reportedly recovered from surgery, however, it is suspected that the air pocket has recurred.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's imaging results reportedly revealed no abnormalities.The recipient continues to experience sound quality issues.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 will not be pursuing revision surgery at this time.The recipient has resumed device use.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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