Model Number CI-1400-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Complaint, Ill-Defined (2331); No Code Available (3191)
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Event Date 12/14/2017 |
Event Type
Injury
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Manufacturer Narrative
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Udi number: na.
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Event Description
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The recipient's device was reportedly explanted.Advanced bionics is in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.
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Manufacturer Narrative
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(b)(4).The external visual inspection revealed the electrode was severed near the electrode ground ring and near the array 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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Manufacturer Narrative
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The recipient reportedly experienced decreased performance.The recipient was reimplanted with another advanced bionics cochlear device on the contralateral side.
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Manufacturer Narrative
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The recipient reportedly experienced device migration due to chronic otitis media.
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Search Alerts/Recalls
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