Model Number CI-1500-04 |
Device Problems
No Audible Prompt/Feedback (2282); Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 07/28/2021 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing loss of sound and open impedances after non-device related surgery.Revision surgery has been scheduled.
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Manufacturer Narrative
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The recipient's device was reportedly 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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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 external visual inspection revealed a severed electrode array as well as cuts to the electrode lead.These are believed to have occurred during revision surgery.Photographic imaging inspection confirmed cut electrode wires.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented an electrical test from being performed.The device passed the electrical tests performed.The device passed the mechanical test performed.The reported complaint of open circuits could not be verified during this analysis., which was limited in some respects due to the electrode being severed prior to receipt.This device passed all of 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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