Model Number CI-1400-01 |
Device Problems
Electrical /Electronic Property Problem (1198); Electro-Static Discharge (2149); Structural Problem (2506)
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Patient Problems
Pain (1994); Insufficient Information (4580)
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Event Date 12/27/2022 |
Event Type
malfunction
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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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Event Description
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The recipient is reportedly experiencing loss of lock.External equipment was exchanged, however the issue did not resolve.Revision surgery is under consideration.
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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 also experienced pain which resolved with programming adjustments.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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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed sliced silicone overmold on the top and bottom covers, as well as a severed electrode.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock could not be obtained at any spacing.The electrode condition prevented an electrical test from being performed.The device passed the mechanical tests performed.Electrical troubleshooting performed revealed a short from a power node to the case ground at the analog chip.The failure of this device is attributed to a short from a power node to the case ground at the analog chip.It is believed that electrostatic discharge (esd) led to an overload voltage, damaging structures on case ground node inside the analog integrated circuit.This ultimately caused the device to cease functioning.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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Manufacturer Narrative
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A review of the device history record was completed and no anomalies were noted.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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