Model Number CI-1500-04 |
Device Problems
Electrical /Electronic Property Problem (1198); Electro-Static Discharge (2149); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/05/2023 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing pain at the implant site following a head trauma.Device testing could not be completed due to recipient discomfort.The recipient has ceased device use.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'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 the electrode was kinked and silicone damage was observed on the top and bottom cover of the device.These are believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.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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