Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/23/2020 |
Event Type
malfunction
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Event Description
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A review of the recipient¿s test data indicated impedance issues.Revision surgery is 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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Advanced bionics considers the investigation into this reportable event as closed.The device passed the external visual inspection.The photographic imaging inspection revealed and electrode wire was broken in the electrode pocket.System lock was verified.The device passed the electrical tests performed.The scanning electron microscopy (sem) analysis revealed corrosion on some electrodes.The device passed the mechanical test performed.The failure of this device is attributed to an electrode short in the electrode pocket.A corrective action was implemented.This version of the ultra 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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