Model Number CI-1400-01 |
Device Problem
Noise, Audible (3273)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/27/2020 |
Event Type
Injury
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Event Description
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The recipient is reportedly experiencing overly loud sound.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.
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Manufacturer Narrative
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Advanced bionics considers the investigation into this reportable event as closed.The device passed the external visual and 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 at the analog integrated circuit.It is believed that electrostatic discharge (esd) led to an overload voltage, damaging structures inside the integrated circuit.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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Manufacturer Narrative
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The recipient's device was explanted.The recipient was re-implanted with another advanced bionics device.Disclaimer: 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 is reportedly experiencing overly loud sound.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.
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Event Description
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The recipient's device was explanted.The recipient was re-implanted with another advanced bionics device.
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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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Search Alerts/Recalls
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