Model Number CI-1400-01 |
Device Problems
Therapeutic or Diagnostic Output Failure (3023); Intermittent Communication Failure (4038)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/16/2020 |
Event Type
malfunction
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Event Description
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The recipient reportedly experienced loss of lock.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics 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 external visual inspection revealed that the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.In addition, broken antenna coil wires were observed.The photographic imaging inspection confirmed a broken antenna coil.System lock could not be obtained at any spacing.The no lock condition prevented some electrical tests from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.This device had broken antenna coil wires.A corrective action was implemented.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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