Model Number CI-1400-01 |
Device Problems
Loose or Intermittent Connection (1371); Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023); Intermittent Communication Failure (4038)
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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 04/14/2022 |
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 is reportedly experiencing loss of lock.External equipment was exchanged, however, the issue did not resolve.Device testing revealed intermittent lock.The recipient ceased device use.Revision surgery will be scheduled.
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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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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 could not be obtained at any spacing.The condition of the electrode prevented an electrical test from being performed.The device passed the electrical tests performed.The device failed the residual gas analysis test.This device has moisture that exceeded the residual gas analysis test limit.Base on the residual gas analysis data, is it determined that his device was non-hermetic.A corrective action was implemented.This version of the hires 90k 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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