Model Number CI-1500-04 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Ulcer (2274)
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Event Date 02/01/2023 |
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 a displaced magnet, and an ulcer at the magnet site, following an mri.Bandaging protocol was not followed.The recipient ceased device use.Revision surgery is scheduled.
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Manufacturer Narrative
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The recipient underwent magnet replacement surgery on (b)(6) 2023.The recipient's activation went well.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 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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