Model Number CI-1601-05 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance.Revision surgery is 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 explanted.The recipient was reimplanted with another advanced bionics cochlear device.Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed silicone damage on the top and bottom cover of the device.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The device passed some of the electrical tests 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 hires ultra 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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