Model Number CI-1400-01 |
Device Problems
Loose or Intermittent Connection (1371); Therapeutic or Diagnostic Output Failure (3023); Appropriate Term/Code Not Available (3191)
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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 07/30/2021 |
Event Type
malfunction
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Event Description
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The recipient reportedly experienced intermittencies.External equipment was exchanged, however, the issue did not resolve.The recipients device was explanted.
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Manufacturer Narrative
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The recipient was reportedly reimplanted with another advanced bionics cochlear device.The recipient¿s device was lost and will 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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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.Device testing was reportedly attempted prior to revision surgery, however, could not be completed due to no lock.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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