Model Number CI-1601-04 |
Device Problems
Therapeutic or Diagnostic Output Failure (3023); Insufficient Information (3190)
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Patient Problem
Failure of Implant (1924)
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Event Date 11/17/2020 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance.Programming adjustments were made and the recipient will continue to be monitored.Revision surgery is being considered.
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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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The recipient¿s device will reportedly not return to advanced bionics for analysis.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.A review of the device history record was completed and no anomalies were noted.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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