Model Number CI-1400-01 |
Device Problems
Electrical /Electronic Property Problem (1198); Loose or Intermittent Connection (1371); Electro-Static Discharge (2149); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Failure of Implant (1924)
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Event Date 02/24/2022 |
Event Type
malfunction
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Event Description
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The recipient reportedly experienced intermittent lock and no sound.External equipment was exchanged, however, the issue did not resolve.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
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Manufacturer Narrative
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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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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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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed the electrode was severed.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock obtained only at certain spacing during stimulation.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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Search Alerts/Recalls
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