Model Number CI-1601-04 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Inflammation (1932)
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Event Date 02/13/2024 |
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 inflammation at implant site.The recipient's device was explanted.
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Manufacturer Narrative
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The recipient reportedly takes medication (types unknown), which caused a wound healing disorder.The recipient will not be reimplanted.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 has reportedly healed.The recipient will be reimplanted at a later date.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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