Model Number CI-1500-04 |
Device Problems
Electrical /Electronic Property Problem (1198); Incorrect, Inadequate or Imprecise Result or Readings (1535); Electro-Static Discharge (2149)
|
Patient Problems
Undesired Nerve Stimulation (1980); Device Overstimulation of Tissue (1991)
|
Event Date 07/07/2021 |
Event Type
malfunction
|
Event Description
|
The recipient is reportedly experiencing facial nerve stimulation.Programming adjustments were made, however, the issue did not resolve.Device testing revealed abnormal results.Revision surgery is under consideration.
|
|
Manufacturer Narrative
|
The recipient's device was 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
|
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 recipient's device activation reportedly went well.The external visual inspection revealed the electrode was severed prior to receipt.This is believed to have occurred during revision surgery.The device passed the 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 a 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 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
|