Model Number CI-1601-05 |
Device Problems
Mechanical Problem (1384); 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 Type
malfunction
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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 decreased performance.A review of the recipient's test data indicates impedance issues.Programming adjustments have been made; however, the issue did not resolve.Revision surgery is under consideration.
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Manufacturer Narrative
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Advanced bionics no longer considers this event reportable.Please refer to mdr # 3006556115-2024-00652 for continued reporting.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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