Model Number CI-1601-05 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Pain (1994)
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Event Date 03/29/2024 |
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 an infection at the implant site following implantation in 2022.The recipient was treated with antibiotics and drainage.The recipient presented with pain and pus.The doctor suspects a biofilm on the device.The recipient's device was explanted.The recipient was will be reimplanted at a later date.
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Manufacturer Narrative
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The recipient's infection has reportedly resolved.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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