Model Number CI-1400-01 |
Device Problems
Misconnection (1399); Therapeutic or Diagnostic Output Failure (3023); Intermittent Communication Failure (4038)
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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 Type
malfunction
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Event Description
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The recipient reportedly experienced no lock with device.Revision surgery is scheduled.
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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.This device is considered a failure in situ.A review of the device history record was performed 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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Revision surgery will reportedly not occur.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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