Model Number CI-1400-01 |
Device Problems
Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191); Intermittent Communication Failure (4038)
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Patient Problem
Insufficient Information (4580)
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Event Date 09/25/2020 |
Event Type
malfunction
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Event Description
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The recipient reportedly experienced intermittent 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 the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection revealed broken antenna coils.System lock was lost while manipulating.The electrode condition prevented an electrical test from being performed.The device passed the electrical tests performed.The device passed the mechanical test 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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