Model Number CI-1400-01 |
Device Problem
Extrusion (2934)
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Patient Problems
Unspecified Infection (1930); Discharge (2225)
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Event Date 03/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Udi number: na.The external visual inspection revealed the electrode was sliced near the electrode ground ring and severed near the array prior to receipt.These are 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 and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.
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Event Description
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The recipient reportedly experienced an infection and device extrusion.The recipient presented with a scab and intermittent drainage at implant site for about 1 month.The recipient's device was explanted.The recipient will be reimplanted once healed.
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Manufacturer Narrative
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The recipient has reportedly healed.This is the final report.
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Search Alerts/Recalls
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