Model Number CI-1400-01 |
Device Problems
Electrical /Electronic Property Problem (1198); Connection Problem (2900); Intermittent Communication Failure (4038)
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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 09/26/2021 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing loss of lock following intermittency for several months.External equipment was exchanged, however, the issue did not resolve.A ct scan revealed no abnormality.Revision surgery will be scheduled.
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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 reportedly explanted.The recipient was re-implanted 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 external visual inspection revealed sliced silicone overmold to the top cover and electrode lead.These anomalies are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was obtained only at certain spacing.The electrode condition prevented an electrical test from being performed.The device passed the some of the electrical tests performed.The device passed the mechanical test performed.The resistance test revealed elevated resistance was measured across the kovar tab.The reported complaint of no lock was confirmed during the analysis of the device.Elevated resistance was measured across an electrical component (kovar tab), which is believed to be related to the loss of lock.An internal corrective action has been implemented.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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