Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); No Apparent Adverse Event (3189)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/15/2023 |
Event Type
Injury
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Event Description
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The company was informed that the recipient's device was explanted, despite the device testing within normal limits.The recipient was not reimplanted.Advanced bionics is still 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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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 and remains in situ.The recipient will not pursue surgery at this time and will be managed by the facility's protocols.No further details will be provided.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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