Model Number CI-1500-04 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Discomfort (2330)
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Event Type
Injury
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Event Description
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The recipient is reportedly experiencing intermittent pain and discomfort at the implant site and around ear.The recipient has been prescribed antibiotics (type unknown) on several occasions, however the issues did not resolve.Programming adjustments have been made.Device testing revealed results within normal limits.
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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.Additional information regarding treatment details were not provided.The recipient's pain is with and without device use.The recipient will reportedly not pursue revision surgery at this time.The recipient is wearing the device.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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