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Model Number CI-1600-04 |
Device Problems
Loose or Intermittent Connection (1371); Mechanical Problem (1384); Output Problem (3005)
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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 09/14/2021 |
Event Type
malfunction
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Event Description
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The recipient reportedly experienced intermittencies.External equipment was exchanged, however, the issue did not resolve.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics device.
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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 damaged silicone on the top and bottom covers, and the electrode was severed near the array prior to receipt.These are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.The scanning electron microscopy analysis of the antenna and electrode epoxy joints did not reveal any cracks.The reported complaint of intermittent lock could not be verified during the analysis of this device.However, the impedance failure of this device is attributed to an electrode short in the electrode pocket.A corrective action was implemented.This version of the hires ultra device is no longer distributed.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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