Model Number CI-1400-01 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/08/2017 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing loss of lock.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.Revision surgery is under consideration.
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Manufacturer Narrative
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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.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was obtained intermittently.The electrode condition prevented some of the electrical tests from being performed.The device passed an electrical test performed.The device failed the residual gas analysis test.This is an interim report.
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Event Description
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The recipient is reportedly experiencing intermittent lock.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.Revision surgery is under consideration.
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Manufacturer Narrative
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The external visual inspection revealed that the array was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was obtained intermittently.The electrode condition prevented some of the electrical tests from being performed.The device passed an electrical test performed.The device failed the residual gas analysis test.The internal visual inspection noted silver migration across some electrical components.This device had moisture that exceed the residual gas analysis test limit.The source of the problem was a feedthru hermiticity issue from one feedthru vendor.A corrective action was implemented.Feedthru assemblies from this vendor are no longer used.This is the final report.
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Search Alerts/Recalls
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