Model Number CI-1400-01 |
Device Problems
Device Inoperable (1663); Programming Issue (3014)
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Patient Problem
No Code Available (3191)
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Event Date 12/12/2017 |
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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Revision surgery is reportedly scheduled.
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Manufacturer Narrative
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The external visual inspection revealed the electrode array was cut prior to receipt as well as the damage to the silastic overmold on the bottom cover.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at any spacing.The no lock condition prevented some of the electrical tests from being performed.The device passed some the electrical tests performed.The device failed the residual gas analysis test.The internal visual inspection noted silver migration across an electrical component.The device had moisture that exceeded the residual gas analysis test limit.Based on an assessment of the residual gas analysis and dye penetrant data, it is believed that this device was non-hermetic, and that the root cause of the excessive moisture was a leak through the feedthru seals.A corrective action was implemented.This is the final report.
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Manufacturer Narrative
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The recipient's device was explanted.The recipient was reimplanted with another advance bionics cochlear device.
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Search Alerts/Recalls
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