Model Number CI-1500-01 |
Device Problems
Electrical /Electronic Property Problem (1198); Electro-Static Discharge (2149); No Audible Prompt/Feedback (2282)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/08/2021 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing a non-auditory sensation during initial stimulation.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.The recipient will not be explanted at this time.The recipient is wearing the device without issue.No further details will be provided.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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Revision surgery is reportedly scheduled.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 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 the electrode was cut prior to receipt.This is believed to have occurred during revision surgery.The device passed the 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.The failure of this device is attributed to a short from power node to electrode ground case at the analog chip.It is believed that electrostatic discharge (esd) lead to an overload voltage, damaging structures on the case ground node inside the analog integrated circuit.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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