Model Number CI-1601-04 |
Device Problems
Mechanical Problem (1384); Migration or Expulsion of Device (1395); Impedance Problem (2950)
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Patient Problems
Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 05/17/2022 |
Event Type
malfunction
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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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Event Description
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The recipient reportedly experienced decreased performance.A review of the test data indicated impedance issues.Programming adjustments were made, however the issue did not resolve.The recipient's device was explanted.It was noted during revision surgery that the device was fully recessed into bone.The recipient was reimplanted with another advanced bionic cochlear device.
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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 device passed external visual and photographic imaging inspection.System lock was verified.The device passed some of the electrical tests performed.The device passed the mechanical 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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