Model Number CI-1400-01 |
Device Problem
Crack (1135)
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Patient Problem
Irritation (1941)
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Event Type
Injury
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Event Description
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The recipient reportedly is reportedly experiencing a small opening at the magnet site caused by irritation.The recipient was reportedly prescribed two rounds of antibiotics.The recipient has discontinued device use.Skin flap revision surgery is under consideration.
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Manufacturer Narrative
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The recipient is reportedly still experiencing a small opening on the skin, however, there is no infection.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's medical issue has resolved and healed.The recipient resumed device use.Additional treatment details will not 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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