Model Number CI-1500-04 |
Device Problems
Electrical /Electronic Property Problem (1198); Electro-Static Discharge (2149); Patient-Device Incompatibility (2682)
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Patient Problems
Pain (1994); Increased Sensitivity (2065); Discomfort (2330)
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Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing pain and non-auditory sensations with device use following an electrostatic discharge event.Device testing could not be completed due the recipient's discomfort.The recipient ceased device use.Revision surgery is scheduled.
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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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The recipient's pain and non-auditory sensations 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 damaged silicone on the bottom cover prior to receipt.This is believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was verified.The device passed some of the electrical 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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