Model Number CI-1400-01 |
Device Problems
Therapeutic or Diagnostic Output Failure (3023); Intermittent Communication Failure (4038)
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Patient Problem
Failure of Implant (1924)
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Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing loss of lock.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.Device testing could not be completed due to loss of lock.Revision surgery will be scheduled.
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Manufacturer Narrative
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The recipient has reportedly been lost to follow up.The recipient is believed to have experienced an in-situ failure.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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