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 Type  malfunction  

Event Description

The user's hearing performance with the device is affected.There is a concern that the electrode has migrated.Re-insertion surgery is scheduled for (b)(6) 2024.

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.

Manufacturer Narrative

Based on the received information from the field, the device did not provide sufficient benefit due to a partial migration of the active electrode out of cochlea, which could be confirmed by diagnostic imaging.A re-insertion surgery was performed successfully.The device remains implanted and in use.This is a final report.

Event Description

The user's hearing performance with the device is affected.There is a concern that the electrode has migrated.The electrode array has been reinserted fully and tested for ift and art.Both tests were reportedly, with normal values.5 channels were found extra-cochlea before re-insertion.Additionally a post-op otoplan on demand was done and the report confirms all electrodes are in the cochlea.

• 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: 18516343
• MDR Text Key: 333195570
• Report Number: 9710014-2024-00041
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737395452
• UDI-Public: (01)09008737395452
• 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: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2024
• 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: 01/11/2024
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 04/02/2024
• 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 Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female