Model Number CI-1600-04 |
Device Problem
Microbial Contamination of Device (2303)
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Patient Problems
Unspecified Infection (1930); Pain (1994); Swelling (2091)
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Event Type
Injury
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Event Description
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The recipient reportedly experienced a middle ear infection which led to the implant site.The recipient presented with swelling and pain.The recipient is using a peripherally inserted central catheter (picc) line.The recipient was treated for a possible biofilm formation.The recipient was prescribed antibiotics.
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Manufacturer Narrative
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The recipient was reportedly hospitalized for over a week due to the implant being infected.The recipient was discharged.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient's infection reportedly resolved.Additional treatments details were not provided.The recipient resumed device use.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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The recipient reportedly experienced infections in december 2018 to january 2019 and in october 2019.Both infections resolved with antibiotics.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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