Model Number CI-1400-01 |
Device Problems
Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/13/2023 |
Event Type
Injury
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Event Description
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The recipient reportedly underwent an mri with the magnet in place.Head bandaging procedure was followed, however, the magnet has reportedly rotated.Device testing was reportedly within normal limits.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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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.The recipient magnet was reportedly repositioned manually.The recipient has resumed device use.No further details will be provided.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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