Model Number CI-1500-01 |
Device Problems
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 05/15/2019 |
Event Type
malfunction
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Event Description
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The recipient is reportedly experiencing loss of lock due to an electrostatic discharge event (esd).External equipment was exchanged and a programming adjustment was made, however, the issue did not resolve.
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Manufacturer Narrative
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The recipient was reportedly reimplanted with another advanced bionics cochlear device.
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Manufacturer Narrative
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The recipient's device was reportedly explanted.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 cut prior to receipt.This is believed to have occurred during revision surgery.The photographic imaging inspection confirmed cut electrode wires.This is believed to have occurred during revision surgery.System lock was obtained only at certain spacing.The no lock condition prevented some of the electrical tests from being performed.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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