Model Number CI-1400-01 |
Device Problems
Mechanical Problem (1384); No Audible Prompt/Feedback (2282); 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 12/30/2021 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing non-auditory sensations and loss of sound.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.
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Manufacturer Narrative
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The recipient's device was 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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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 tool damage to the top and bottom covers, as well as a severed electrode.These are believed to have occurred during revision surgery.In addition, a crack in the seam weld was observed.The device passed the photographic imaging inspection.System lock obtained only at certain spacing.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 failure of this device is attributed excessive moisture through a gross leak at the seam weld.This ultimately caused the device to cease functioning.A corrective action was implemented.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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