Model Number CI-1500-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Headache (1880); Tinnitus (2103); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/06/2023 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing sound quality issues with and without device use.Device testing revealed results within normal limits.External equipment was exchanged and programming adjustments were made, however the issue did not resolve.A ct scan revealed no anomalies.The recipient is presenting with tinnitus and headaches.The recipient was prescribed prednisone.The recipient ceased device use.
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Manufacturer Narrative
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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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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 tinnitus and headaches have reportedly resolved.The external visual inspection revealed sliced silicone overmold on the top cover, as well as a severed electrode.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The condition of the electrode 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 older device configuration is not currently manufactured.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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