Model Number CI-1601-04 |
Device Problems
Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/14/2022 |
Event Type
malfunction
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Event Description
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Advanced bionics was informed that device testing revealed abnormal results.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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Additional information: section d.7.Advanced bionics considers the investigation into this reportable event as closed.The recipient will not be explanted at this time.The recipient continues to use the device.No further details will be provided.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 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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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed a slice in the electrode below the electrode ground ring.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed broken electrode wires.This is believed to have occurred during revision surgery.In addition, this inspection revealed some electrodes were broken within the electrode pocket.System lock was verified.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 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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