Model Number SONATA |
Device Problem
Impedance Problem (2950)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 03/25/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
|
|
Event Description
|
The user was brought to the clinic reporting not responding to sound.End of (b)(6)2024 the child fell down and got hit on the implant site and notices issues afterwards.Re-implantation is considered.It was recommended to take x-ray/ct-scan.
|
|
Event Description
|
The user was brought to the clinic reporting not responding to sound.End of (b)(6) 2024, the child fell down and got hit on the implant site which let to the noted issues afterwards.Re-implantation is considered.It was recommended to take x-ray/ct-scan.
|
|
Manufacturer Narrative
|
Additional information: based on the received information, a damage to the active electrode due to the reported mechanical impact appears very likely.However, to determine an exact root cause device investigation would be necessary.Re-implantation is considered but no date has been scheduled yet.
|
|
Search Alerts/Recalls
|