The recipient reportedly experienced loss of 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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The device passed the external visual and photographic imaging inspections.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 of the electrical tests performed.The device failed the residual gas analysis test.The internal visual inspection revealed that a resistor had a corroded trace.In addition, a broken substrate was observed, which was induced during the failure analysis process.It is believed that the failure of this implantable cochlear stimulator (ics) device was caused by a loss of hermetic seal.This is concluded from the residual gas analysis data.Moisture admitted into this device through this leak resulted in the corrosion of the resistive film material and the 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.
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