Model Number MI1200 SYNCHRONY |
Device Problem
Migration (4003)
|
Patient Problem
Implant Pain (4561)
|
Event Date 08/21/2020 |
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 user has been experiencing persistent pain/soreness around the implant site, which is worse when smiling or moving the muscles around the site.This problem has been happening since implantation.The user had good sound quality and performance with the device.Per patient report, over time the position of the device had shifted inferiorly.The user was re-implanted.
|
|
Manufacturer Narrative
|
Conclusion: device investigation did not reveal any device defect or damage which has been present whilst implanted.Mechanical damages found during device investigation are attributable to the removal surgery.According to the information received from the field the recipient experienced pain and discomfort since implantation, which were most likely caused by a migration of the implant from its intended position.A re-positioning surgery was performed.However during the surgical intervention the electrode array was accidentally pulled out of cochlea.Therefore, the device was explanted and a back-up device was implanted.This is a final report.
|
|
Event Description
|
The user has been experiencing persistent pain/soreness around the implant site, which was worse when smiling or moving the muscles around the site.This problem has been happening since implantation.X-ray showed receiver stimulator was placed on bone, but the coil portion was superficial to muscle.Per patient report, over time the position of the device had shifted inferiorly.The user had good sound quality and performance with the device.Revision surgery took place on (b)(6) 2020.
|
|
Search Alerts/Recalls
|