Model Number CI-1500-04 |
Device Problems
Electrical /Electronic Property Problem (1198); No Audible Prompt/Feedback (2282)
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Patient Problems
Hearing Impairment (1881); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 06/03/2021 |
Event Type
malfunction
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Event Description
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The recipient reportedly experienced no sound.Programming adjustments were made, however, the recipient is now presenting with sound quality issues.Additional programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.External visual inspection revealed tool damage to the top and bottom covers.In addition, the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The device passed the electrical and mechanical tests performed.Internal visual inspection revealed a cracked hybrid.The reported complaint of no sound and open electrodes with the device was verified during the analysis.The device was received with multiple cracks along the hybrid.A corrective action was implemented.This is the final report.
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Manufacturer Narrative
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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.External visual inspection revealed tool damage to the top and bottom covers.In addition, the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The electrode condition prevented some electrical tests from being performed.The device passed the electrical and mechanical tests performed.Internal visual inspection revealed a cracked hybrid.The reported complaint of no sound and open electrodes with the device was verified during the analysis.The device was received with multiple cracks along the hybrid.A corrective action was 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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