Model Number CI-1500-04 |
Device Problem
Material Protrusion/Extrusion (2979)
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Patient Problem
Unspecified Infection (1930)
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Event Date 10/17/2018 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced an infection.The recipient presented with wire extrusion and drainage.The recipient underwent repositioning and debridement surgery on (b)(6) 2018.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device on the contralateral side.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient has reportedly healed.The external visual inspection revealed the electrode was severed near the fantail prior to receipt.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 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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Event Description
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The recipient reportedly experienced an infection.The recipient presented with wire extrusion and drainage.The recipient underwent repositioning and debridement surgery on (b)(6) 2018.The recipient was doing well, however, the drainage recurred.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device on the contralateral side.
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Search Alerts/Recalls
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