Model Number CI-1400-02H |
Device Problems
Electrical /Electronic Property Problem (1198); Misconnection (1399); Electro-Static Discharge (2149)
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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 09/07/2022 |
Event Type
malfunction
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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 scheduled.
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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's device was explanted.The recipient was re-implanted 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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Additional information: section d.9.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 device passed external visual inspection.The device passed photographic imaging inspection.System lock could not be obtained at any spacing.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.Electrical troubleshooting performed revealed a short between the power node and electrode ground case, and a short between the voltage ground and electrode ground case inside the analog chip.The failure of this device is attributed to a short from the 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 the 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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Search Alerts/Recalls
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