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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Granuloma (1876)
Date of Event	11/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Explantation on (b)(6) 2025 due to granulations in the area of the implant bearing that led to swelling and pain above the implant.Reimplantation is planned but not scheduled yet.
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.
Event or Problem Description
Explantation on (b)(6) 2025 due to granulations in the area of the implant bearing that led to swelling and pain above the implant.
Additional Manufacturer Narrative
Conclusion: device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.Damages found during device investigation are most likely related to the explantation surgery.According to information received, the device was explanted due to granulation tissue around the implant area of unclear etiology.A review of the device_s sterilization records shows that the device has been subjected to a valid sterilization process.This is a final report.

• 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: 23645883
• Report Number: 9710014-2025-01109
• Device Sequence Number: 14658626
• Product Code: MCM
• UDI-Device Identifier: 09008737395476
• UDI-Public: (01)09008737395476
• 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: 2021
• Device Explanted Year: 2025
• 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): 01/07/2026

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: 11/05/2023
• Device Model Number: MI1250 SYNCHRONY 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2020
• 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: 57 YR
• Patient Sex: Female