Model Number AB-5100H-11A |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/30/2018 |
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 will be scheduled.
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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 a severed array, as well as a damaged epoxy header region.These anomalies are believed to have occurred during revision surgery.The photographic imaging inspection confirmed severed electrode wires at the epoxy header region.This is believed to have occurred during revision surgery.System lock could not be obtained at any spacing.The no lock condition prevented some of the electrical tests from being performed.This is an interim report.
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Manufacturer Narrative
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The external visual inspection revealed a severed array, as well as a damaged epoxy header region.These anomalies are believed to have occurred during revision surgery.The photographic imaging inspection confirmed severed electrode wires at the epoxy header region.This is believed to have occurred during revision surgery.System lock could not be obtained at any spacing.The no lock condition prevented some of the electrical tests from being performed.The manual capacitor leakage test revealed unstable readings due to flooded components.The failure of this device is attributed to excessive moisture through a gross leak at the case-band braze.This ultimately caused the device to cease functioning.This older device configuration is no longer manufactured.This is the final report.
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Search Alerts/Recalls
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