MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SYNCHRONY; COCHLEAR IMPLANT

Model Number MI1250 SYNCHRONY 2

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 05/01/2023

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 implanted in september 2020.After approximately 2 years, it was observed that electrodes 11 and 12 were migrating out of the cochlea, which was confirmed through a ct scan.Despite the migration, the user's hearing and understanding were reportedly not affected.

Event Description

The user's hearing performance with the device is affected.Revision surgery or reimplantation was scheduled for (b)(6) 2024, but was then postponed.No further date for the surgery has been scheduled so far.

Manufacturer Narrative

Additional information: according to the information received, the device is not providing satisfactory benefit to the recipient due to a post-operative active electrode migration out of the cochlea.A revision surgery is planned but no date has been scheduled yet.

• Brand Name: SYNCHRONY
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 18569443
• MDR Text Key: 333548733
• Report Number: 9710014-2024-00075
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737366827
• UDI-Public: (01)09008737366827
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/10/2023
• Device Model Number: MI1250 SYNCHRONY 2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 01/24/2024
• Supplement Dates Manufacturer Received: 01/18/2024
• Supplement Dates FDA Received: 04/23/2024
• Date Device Manufactured: 03/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Sex: Female