Model Number CI-1600-04 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/16/2020 |
Event Type
Injury
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Event Description
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The recipient's device was reportedly explanted.Advanced bionics is 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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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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Additional information: section a.2 correction: section d.6 advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed silicone slices on the bottom cover prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed the electrical and mechanical tests performed.This device was explanted for medical reasons.The device passed the tests performed.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 reportedly explanted due to poor adaptation of the device.The recipient was not reimplanted.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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