Model Number CI-1500-01 |
Device Problems
Expulsion (2933); Material Protrusion/Extrusion (2979); Appropriate Term/Code Not Available (3191)
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Patient Problems
Failure of Implant (1924); Unspecified Infection (1930)
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Event Date 08/12/2021 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced an infection followed by device extrusion.The recipient's device was explanted.
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Manufacturer Narrative
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The recipient's infection reportedly resolved and the recipient is doing well.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 cuts in the top cover overmold and in the fantail region.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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.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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Search Alerts/Recalls
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