Model Number CI-1601-05 |
Device Problems
Defective Component (2292); Difficult to Open or Remove Packaging Material (2922); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Failure of Implant (1924)
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Event Date 05/11/2020 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing a partial electrode insertion.Programming adjustments were made, however, the issue did not resolve.Revision surgery is scheduled.
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Manufacturer Narrative
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The recipient's device was explanted.The recipient was reimplanted with another cochlear device.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 external visual inspection revealed slices on the top cover and fantail, silicone damage on the bottom cover, and the electrode was severed near the array prior to receipt.These are believed to have occurred during revision surgery.The photographic imaging inspection confirmed cut electrode wired near the fantail.This is believed to have occurred during revision surgery.System lock was verified.The electrode condition prevented an electrical test from being performed.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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