Model Number CI-1400-01 |
Device Problems
Electrical /Electronic Property Problem (1198); Electro-Static Discharge (2149); Intermittent Communication Failure (4038)
|
Patient Problem
Pain (1994)
|
Event Date 07/12/2023 |
Event Type
malfunction
|
Event Description
|
The recipient is reportedly experiencing pain.The recipient refuses to wear device.External equipment was exchanged and programming adjustments were made, however, the issues did not resolve.The recipient's device was explanted.The recipient was reimplanted with another advanced bionics cochlear device.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
A review of the device history record was completed and no anomalies were noted.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 the electrode was severed and silicone damage was observed on the top cover of the device.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The electrode condition prevented an electrical test 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.
|
|
Search Alerts/Recalls
|