Model Number CI-1500-04 |
Device Problems
Electrical /Electronic Property Problem (1198); Electro-Static Discharge (2149); Output Problem (3005)
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Patient Problem
Undesired Nerve Stimulation (1980)
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Event Date 09/27/2021 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing facial nerve simulation with device use.Programming adjustments were made, however, the issue did not resolve.Revision surgery is scheduled.
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Manufacturer Narrative
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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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The recipient's activation went well.The recipient's facial nerve stimulation is resolved.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 that the electrode lead 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 an electrical test from being performed. the device passed some of the electrical tests 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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Search Alerts/Recalls
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