Model Number CI-1601-05 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Burning Sensation (2146); Alteration in Body Temperature (4568)
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Event Date 06/22/2022 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing a hot sensation and headaches with and without device use.Revision surgery is scheduled.
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Manufacturer Narrative
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The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.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.The recipient's device was successfully activated and is able to use the device full time.The external visual inspection revealed tool damage in the silicone overmold on the top cover, as well as cuts on the bottom cover and the fantail region.These anomalies 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.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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