Model Number CI-1600-04 |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Type
Injury
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Event Description
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The recipient was reportedly a poor performer and non-user of the device.The recipient elected explant surgery.The recipient's device was explanted.The recipient will not be reimplanted.The recipient is in the process of healing.
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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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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient's device was reportedly not explanted.The recipient has other health issues.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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