Model Number CI-1400-01 |
Device Problems
Electrical Shorting (2926); Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)
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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 01/25/2022 |
Event Type
malfunction
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Event Description
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The recipient reportedly experienced shorted electrodes and decreased performance.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
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Manufacturer Narrative
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Additional information: section d.9.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 the electrode was severed.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 some of the electrical tests performed.The device passed the mechanical test performed.The reported complaint of short circuits could not be verified during this analysis, which was limited due to the electrode being severed prior to receipt.This device failed rf testing however, this is not believed to have contributed to the return reason.This version of the hires 90k device is no longer distributed.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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