Model Number CI-1600-04 |
Device Problems
Mechanical Problem (1384); Impedance Problem (2950); Output below Specifications (3004)
|
Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/09/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
|
|
Event Description
|
The recipient is reportedly experiencing decreased performance.A review of the recipient¿s test data indicated impedance issues.Revision surgery is scheduled.
|
|
Manufacturer Narrative
|
Advanced bionics considers the investigation into this reportable event as closed.The external visual inspection revealed the electrode array was severed.This is believed to have occurred during revision surgery.The device passed photographic imaging inspection.System lock was verified.The condition of the electrode 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 an electrode short in the electrode pocket.A corrective action was implemented.This version of the hires ultra device is no longer distributed.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
|
Additional information: sections b.3, b.6, d.6b, & d.9.The recipient's device was reportedly explanted.The recipient was reimplanted 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 date of the initial report is corrected to (b)(6) 2022.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
|