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Model Number CI-1600-04 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Output below Specifications (3004)
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Patient Problems
Therapeutic Response, Decreased (2271); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient has decided to not pursue explant surgery at tis time.The recipient remains implanted.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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