Model Number CI-1400-01 |
Device Problems
Electro-Static Discharge (2149); Appropriate Term/Code Not Available (3191); Noise, Audible (3273)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 06/03/2020 |
Event Type
malfunction
|
Event Description
|
The recipient is reportedly experiencing overly loud sound.External equipment was exchanged and programming adjustments were made, however, the issue did not resolve.Revision surgery will be scheduled.
|
|
Manufacturer Narrative
|
The recipient's device was reportedly 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.
|
|
Manufacturer Narrative
|
Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed that the electrode was severed prior to receipt.In addition, tool damage was noted on the top and bottom cover and the electrode ground ring was missing.All these anomalies are believed to have occurred during revision surgery.The device passed the photographic imaging inspection.System lock was obtained only at certain spacing.The electrode condition prevented some electrical tests from being performed.The device passed some of the electrical tests performed.The device passed the mechanical tests performed.He 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 is ultimately 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.
|
|
Manufacturer Narrative
|
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Search Alerts/Recalls
|