Model Number C40+ |
Device Problem
Circuit Failure (1089)
|
Patient Problem
Failure of Implant (1924)
|
Event Date 12/06/2023 |
Event Type
malfunction
|
Event Description
|
Reportedly, after a severe blow to the head on 28-nov-2023, the user was only able to hear intermittently sounds with the device.
|
|
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.
|
|
Manufacturer Narrative
|
Conclusion: the device investigation revealed mechanical damage to the stimulator housing and electronics that is typical for severe external impact to the housing.The problems described in the recipient report and the reported accident appears to match the damage found.This is a final report.
|
|
Event Description
|
Reportedly, after a severe blow to the head on (b)(6) 2023, the user was only able to hear intermittently sounds with the device.
|
|
Search Alerts/Recalls
|