Model Number CI-1601-04 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Lack of Effect (4065)
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Patient Problems
Headache (1880); Pain (1994)
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Event Date 05/02/2023 |
Event Type
Injury
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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 sound quality issues.The recipient presents with pain and migraines.Programming adjustments were made, however, the issue did not resolve.The recipient is taking medication.The neurologist believes the issues are related to ci.Revision surgery is under consideration.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient will reportedly not pursue revision surgery at this time.The recipient is wearing the device.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.Legal proceeding have prohibited the testing and failure analysis of the explanted device.As a result, no conclusion can be drawn at this time.If the legal proceedings allow for the analysis to be completed, the issue will be re-opened and the results of the analysis will be reported.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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The recipient's device was explanted.The recipient was reimplanted with another advanced bionics device.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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