Model Number CI-1400-01 |
Device Problems
Mechanical Problem (1384); Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Date 11/06/2019 |
Event Type
malfunction
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Event Description
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The recipient reportedly experienced intermittent lock.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
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Manufacturer Narrative
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The external visual inspection revealed that the array was severed prior to receipt.In addition, the electrode ground ring sleeve was dislodged.These anomalies are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.The electrode condition prevented some electrical tests from being performed.The device passed some of the electrical tests performed.This is an interim report.
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Manufacturer Narrative
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Additional information obtained reportedly indicates that the reason for explant was due to loss of lock.
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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 that the array was severed prior to receipt.In addition, the electrode ground ring sleeve was dislodged.These anomalies are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented some electrical tests from being performed.The device passed the electrical and mechanical tests performed.The scanning electron microscopy analysis revealed cracked conductive epoxy at the feedthru pin connection on some pins.This device malfunctioned due to a crack in the conductive epoxy at the feed thru pin-to-substrate connection.A corrective action was implemented.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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