Model Number CI-1500-01 |
Device Problems
Migration or Expulsion of Device (1395); Expulsion (2933)
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Patient Problem
Unspecified Infection (1930)
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Event Date 01/13/2023 |
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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The recipient is reportedly experiencing a skin flap infection and electrode extrusion.The recipient was taken to the hospital.The recipient was recommended antibiotics and ointment for wound healing.Revision surgery is under consideration.
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Manufacturer Narrative
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The recipient's infection reportedly did not resolve with antibiotics.The recipient's device was explanted.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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Manufacturer Narrative
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The recipient has reportedly healed.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 external visual inspection revealed cuts in the silicone overmold on the top cover, as well as a severed electrode.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical tests performed.The device passed the mechanical test performed.This device was explanted for medical reasons.The device passed the tests performed.This older device configuration is not currently manufactured.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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Search Alerts/Recalls
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