Model Number CI-1600-05 |
Device Problems
Mechanical Problem (1384); Battery Problem (2885); Therapeutic or Diagnostic Output Failure (3023)
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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 03/10/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient continues to be monitored per center protocol.This is the final report.
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Event Description
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The recipient is reportedly experiencing decreased performance and battery life.Programming adjustments were made, however, and the issues resolved.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.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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Sections b.3, d.6b 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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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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Correction: section b.3, d.3a, d.6b.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 b.3, d.6a, & d.6b advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed the electrode array was severed prior to receipt and silicone damage was observed on the top cover of the device.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test from being performed.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 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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