Model Number CI-1400-01 |
Device Problems
Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/22/2021 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing loss of lock.Device testing revealed results within normal limits.External equipment was exchanged and programming adjustments were made, however, the issues 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 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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The external visual inspection revealed the electrode was cut prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at any spacing.The no lock condition prevented an electrical test from being performed.The device passed some of the electrical tests performed.The device failed the residual gas analysis test.This device has moisture that exceeded the residual gas analysis test limit.The source of the problem was a feedthru hermeticity issue from one feedthru vendor.A corrective action was implemented.Feedthru assemblies form this vendor are no longer used.This version of the hires 90k device are 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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