Model Number CI-1601-05 |
Device Problems
Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993); Output below Specifications (3004)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/28/2022 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance.A review of the device test data revealed results within normal limits.Revision surgery 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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Additional information: section b.3, d.6b, d.9.The recipient's device was 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 external visual inspection revealed cuts in the silicone overmold on the top and bottom covers, as well as a severed electrode.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The condition of the electrode prevented and electrical test from being performed.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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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