Model Number CI-1500-04 |
Device Problems
Electrical /Electronic Property Problem (1198); Electro-Static Discharge (2149); Intermittent Communication Failure (4038)
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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 11/28/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The recipient reportedly experienced a failure in-situ.A review of the device history record was completed and no anomalies were noted.The recipient remains implanted.This is the final report.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 reportedly experienced loss of lock.Device testing could not be performed due to loss of lock.The recipient ceased device use.
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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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Revision surgery is 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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Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed the electrode was severed and silicone damage was observed on the bottom cover of the device.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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Search Alerts/Recalls
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