Model Number CI-1400-02H |
Device Problems
Device Unsafe to Use in Environment (2918); Migration (4003)
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Patient Problem
Failure of Implant (1924)
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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 did not undergo further medical treatment.The recipient reportedly resumed device use and is doing well.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 reportedly experienced magnet displacement following an mri.The recipient's magnet was replaced during an office procedure.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The magnet was reportedly not replaced.The skin over the magnet site was opened and the same magnet was put back into place.Additional details regarding treatment will not be provided.This is the final report.
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Search Alerts/Recalls
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