Model Number CI-1400-01 |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problems
Inflammation (1932); Fluid Discharge (2686); No Code Available (3191)
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Event Date 03/28/2019 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced device extrusion with serous secretion,a pneumatized mastoid, and a sealed cochleostomy.The recipient underwent surgery and had the inflammatory material removed and had the cochleostomy occluded.
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Manufacturer Narrative
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During surgery, an infection was reportedly noted and removed.The recipient's device was also explanted.The recipient is doing well.
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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 silicone damage on the top and bottom covers and a migrated electrode ground ring.In addition, the electrode was severed near the electrode ground ring prior to receipt.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.This is the final report.
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Search Alerts/Recalls
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