Model Number CI-1601-04 |
Device Problems
Mechanical Problem (1384); Output below Specifications (3004)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 03/11/2021 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance.Device testing could not be completed due to recipient's noncompliance.Revision surgery will be scheduled.
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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 that the array was severed prior to receipt, as well as sliced silicone overmold on the top and bottom covers.These anomalies are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed some of the electrical tests performed.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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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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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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