Model Number CI-1400-01 |
Device Problems
Electrical /Electronic Property Problem (1198); Output Problem (3005); Intermittent Communication Failure (4038)
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Patient Problems
Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/07/2023 |
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.Device testing revealed loss of lock.The recipient ceased device use.
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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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Manufacturer Narrative
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Additional information: sections b.3, d.6, & d.9.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.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.This is believed to have occurred during revision surgery.The device passed the photographic imaging.System lock could not be obtained at any spacing.The electrode condition prevented an electrical test from being performed.The device passed the electrical tests performed.The device failed the residual gas analysis test limit.It is believed that the failure of the implantable cochlear system (ics) device was caused by a loss of hermetic seal, which was concluded from the rga data.This ultimately caused the device to cease functioning.This older device is no longer manufactured.Corrective actions were implemented.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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Search Alerts/Recalls
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