Model Number MI1210 SYNCHRONY ST |
Device Problems
Output Problem (3005); Migration (4003)
|
Patient Problems
Failure of Implant (1924); Discomfort (2330)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
|
|
Event Description
|
Reportedly the user has affected channels.During the activation the user reported auditory sensation along with discomfort.
|
|
Manufacturer Narrative
|
Additional information: according to the information received, in situ measurements during initial activation showed several channels with high impedance for reasons that could not be determined.To determine an exact root cause a device investigation of the explanted device is necessary.Reportedly the user is satisfactorily benefitting from the device, which remains implanted and in use.
|
|
Event Description
|
Reportedly the user has affected channels.During the activation the user reported auditory sensation along with discomfort.The user did not report and trauma to the head/ implant region.During a follow-up appointment, on (b)(6) 2020, the user presented positive and satisfactory results and the auditory perception with the device was much better.No in situ measurements were received for this session.The user will be followed-up in (b)(6) 2020.
|
|
Manufacturer Narrative
|
Additional information: according to the information received, in situ measurements during initial activation showed several channels with high impedance for reasons that could not be determined.To determine an exact root cause a device investigation of the explanted device is necessary.Reportedly the user is benefitting from the device, which remains implanted and in use.
|
|
Event Description
|
Reportedly the user has affected channels.During the activation the user reported auditory sensation along with discomfort.The user did not report and trauma to the head/ implant region.There have been no changes to the user's health or medication.During a follow-up appointment, on (b)(6)2020, the user presented positive and satisfactory results and the auditory perception with the device was much better.No in situ measurements were received for this session.A re-fitting of the device to deactivate the affected channels was conducted, and per information received on (b)(6)2021, these adjustments allowed the user to obtain hearing sensation from the device without discomfort.The user will be seen for a follow-up the following month.
|
|
Event Description
|
Reportedly the user has affected channels.During the activation the user reported auditory sensation along with discomfort.The user did not report and trauma to the head/ implant region.There have been no changes to the user's health or medication.During a follow-up appointment, on (b)(6) 2020, the user presented positive and satisfactory results and the auditory perception with the device was much better.No in situ measurements were received for this session.A re-fitting of the device to deactivate the affected channels was conducted, and per information received on 17 february 2021, these adjustments allowed the user to obtain hearing sensation from the device without discomfort.As per additional information, diagnostic imaging indicates that the electrode array is not in the cochlea.The user was advised not to wear the device.A revision surgery is considered, however, a date has not yet been determined.
|
|
Manufacturer Narrative
|
Additional information: according to the information received, the active electrode migrated out of cochlea, as confirmed by diagnostic imaging.In addition, in situ measurements during initial activation showed several channels with high impedance, for reasons that could not be determined, resulting in three deactivated channels.To determine an exact root cause a device investigation of the explanted device is necessary.Revision surgery is planned but no date has been scheduled yet.
|
|
Search Alerts/Recalls
|