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

Model Number	MI1250 SYNCHRONY 2 PIN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Skin Infection (4544)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user had a skin injury behind the ear in the form of two round circles.The stitches from the implantation had become infected as well.The user has been explanted on (b)(6) 2026.The reimplantation is scheduled in 8 weeks.
Additional 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.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the device was explanted due to an infection with skin necrosis.Review of the device_s sterilization records show that the device has been subject to a valid sterilization process, thus no available information points to the implant being the source of the reported issue.The explanted device has not been received for investigation yet.
Event or Problem Description
The user had a skin infection behind the ear in the form of two round circles with skin necrosis.The stitches from the implantation had become infected as well.The user has been explanted on (b)(6) 2026.

• 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: 25093596
• Report Number: 9710014-2026-00415
• Device Sequence Number: 14703641
• Product Code: MCM
• UDI-Device Identifier: 09008737366810
• UDI-Public: (01)09008737366810
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/21/2023
• Device Model Number: MI1250 SYNCHRONY 2 PIN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 06/18/2026
• Date Device Manufactured: 01/21/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 10 YR
• Patient Sex: Unknown