Model Number CI-1400-02H |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Ulcer (2274)
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Event Date 04/04/2023 |
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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In (b)(6) 2021, the recipient reportedly experienced a skin ulcer.The recipient is an inconsistent device user.The recipient was prescribed mupirocin ointment twice a day for 60 days; however, the issue did not resolve.Cultures were positive for pan-sensitive s.Capitis and cornyebacterium.The recipient's device was explanted.The recipient was not reimplanted.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.Due diligence attempts to obtain additional details regarding the recipient's status were unsuccessful.Additional information regarding the recipient's status 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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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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The external visual inspection revealed sliced silicone overmold on the top and bottom covers, as well as a severed electrode.These anomalies are believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The condition of the electrode prevented an electrical test from being performed.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.This version of the hires 90k device is no longer distributed.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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