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

Model Number	MI1210 SYNCHRONY ST
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	05/01/2025
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
The magnet strength was adjusted.During a routine medical examination on (b)(6) 2025 it was noted that the implant housing is protruding and is partially exposed.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the recipient's implant extruded through the skin.A review of the device's sterilization records shows that the device has been subject to a valid sterilization process.No available information points to the implant being the source of infection.A skin flap revision was done and the device will remain implanted and in use.This is a final report.
Event or Problem Description
The magnet strength was adjusted.During a routine medical examination on (b)(6) 2025 it was noted that the implant housing is protruding and is partially exposed.A skin flap revision was done on (b)(6) 2025 and the device will remain in the user as it is working within specifications.

• Brand Name: SYNCHRONY
• Common Device Name: 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: 23218276
• Report Number: 9710014-2025-00923
• Device Sequence Number: 13216674
• Product Code: MCM
• UDI-Device Identifier: 09008737331870
• UDI-Public: (01)09008737331870
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/19/2021
• Device Model Number: MI1210 SYNCHRONY ST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/05/2025
• Supplement Report FDA Received Date: 12/22/2025
• Date Device Manufactured: 02/19/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Female