Model Number CI-1600-04 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Discomfort (2330); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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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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Event Description
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The recipient reportedly experienced a flipped magnet and pain following an mri.Head bandaging procedure was followed.The doctor was able to manually reposition the magnet.An x-ray confirmed the magnet was re-seated.Advanced bionics is still in the process of obtaining additional information.When additional information is received, a supplemental report will be submitted.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.It is believed the magnet was massaged back into place.The recipient has reportedly healed.The recipient is wearing the device without any discomfort.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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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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