Model Number AB-5100R |
Device Problems
Mechanical Problem (1384); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Hearing Impairment (1881)
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Event Date 09/09/2020 |
Event Type
malfunction
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Event Description
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The recipient reportedly experienced loss of lock.External equipment was exchanged, 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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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The device passed the external visual and photographic imaging inspections.System lock could not be obtained at any spacing.The device passed some of the electrical tests performed.The device failed the residual gas analysis test.It is believed that the failure of this implantable cochlear stimulator device was caused by a loss of hermetic seal which was concluded from the residual gas analysis test data.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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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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