Model Number CI-1600-05 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950)
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Patient Problems
Failure of Implant (1924); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/23/2022 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing decreased performance.A review of the recipient¿s test data indicated impedance issues.Programming adjustments were made, however, the issue did not resolve.Revision surgery is under consideration.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient has decided to not pursue revision surgery at this time.The recipient is wearing the device and will be managed 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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Corrections: sections d.6b & h.4 additional information: section b.3 the recipient's device was reportedly 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 tool damage in the silicone overmold on the top and bottom covers, as well as a severed electrode.These are believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock is verified.The condition of the electrode prevented an electrical test from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests 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 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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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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