Model Number CI-1601-05 |
Device Problems
Application Program Problem (2880); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
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 intermittency at initial stimulation.The recipient is presenting with skin flap thickness and this is believed to be causing the intermittency issue.Programming adjustments were made, however, the issue did not resolve.Skin flap thinning surgery is scheduled.
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Manufacturer Narrative
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The recipient's issues have reportedly resolved.The recipient's skin flap has healed.The recipient is using the device.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 presenting with darkening skin and no breakdown at the skin flap.The recipient was instructed to cease device use.The recipient was prescribed antibiotics for 7 days.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.On
(b)(6) 2020, the recipient reportedly underwent skin flap thinning surgery.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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