Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); Output below Specifications (3004); Insufficient Information (3190)
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Patient Problems
Therapeutic Response, Decreased (2271); Insufficient Information (4580)
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Event Date 04/15/2021 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance.Programming adjustments were made, however, the issue did not resolve.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient's device will reportedly not be explanted at this time.The recipient continues to use the device and will followed per center protocol.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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Manufacturer Narrative
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The recipient's device was reportedly explanted.The recipient was not reimplanted.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 sliced silicone overmold to the top and bottom covers.This is 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 test performed.The failure of this device is attributed to an electrode short in the electrode pocket.A corrective action was implemented.This version of the 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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