Model Number CI-1400-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Swelling/ Edema (4577)
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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 is reportedly experiencing swelling and pain at implant site due to a flipped magnet following an mri.Bandaging protocol was not followed.The recipient is reportedly using anti-inflammatory medication (type unknown).The recipient is reportedly using the device.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.Additional information regarding treatment details were not provided.The recipient's issues reportedly resolved.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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