Model Number CI-1600-04 |
Device Problems
Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Implant Pain (4561); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/11/2022 |
Event Type
Injury
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Event Description
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The recipient reportedly experienced a displaced magnet following an mri.The bandaging protocol was not followed.The recipient presented with a bump at the implant site.The recipient's magnet was removed on (b)(6) 2022.The recipient's magnet was replaced.The recipient is doing well.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly resumed device use.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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