Model Number SONATA |
Device Problem
Output Problem (3005)
|
Patient Problem
Head Injury (1879)
|
Event Date 06/25/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
The device has been explanted and 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 parents reported that the user's hearing performance with the device declined after a head trauma occurred.After 2 months of observation there was no improvement.The user was re-implanted on (b)(6) 2020.
|
|
Manufacturer Narrative
|
Conclusion: the investigation results confirmed that the device has failed due to an external impact to the active electrode.All the problems given in the recipient report appear to match well with this finding.This is a final report.
|
|
Event Description
|
The parents reported that the user's hearing performance with the device declined after a head trauma occurred.After 2 months of observation there was no improvement.The user was re-implanted on (b)(6) 2020.
|
|
Search Alerts/Recalls
|