Model Number AB-5100R |
Device Problem
Mechanics Altered (2984)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/19/2019 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing intermittent lock.External equipment was exchanged, however, the issue did not resolve.Revision surgery is scheduled.
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Manufacturer Narrative
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The external visual inspection revealed the electrode was cut prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System could not be obtained at any spacing.The electrode condition prevented an electrical test from being performed.This is an interim report.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 the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock could not be obtained at any spacing.The electrode condition prevented an electrical test performed.The device passed the electrical tests performed.The device failed the residual gas analysis test limit.The internal visual inspection revealed that a resistor had a corroded trace.It is believed that the failure of this implantable cochlear stimulator device was caused by a loss of hermetic seal.This is concluded from the residual gas analysis test data.Moisture admitted into this device through this leak resulted in the corrosion of the resistive film material and thee shift in resistance value of a resistor.This ultimately caused the device to cease functioning.This older device configuration is no longer manufactured.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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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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Search Alerts/Recalls
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