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Model Number CI-1400-01 |
Device Problem
Intermittent Communication Failure (4038)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/28/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient will not pursue revision surgery and will be a non user of the device.This device is considered a failure in situ.A review of the device history record was performed and no anomalies were noted.No further details will be provided.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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Event Description
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The recipient is reportedly experiencing loss of lock.Device testing could not be completed due to loss of lock.External equipment was exchanged, however the issue did not resolve.
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Search Alerts/Recalls
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