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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user's electrode array has extruded past post-auricular skin in 2025, per surgeon this is related to recipient_s medical history of whole brain radiation, poor skin quality and graft reabsorption.Reimplantation is scheduled for (b)(6) 2025.This report refers to 9710014-2025-01159.For further information please refer to this report.

• Brand Name: SYNCHRONY
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 23800408
• Report Number: 1066702-2025-00024
• Device Sequence Number: 15770638
• Product Code: MCM
• UDI-Device Identifier: 09008737094003
• UDI-Public: (01)09008737094003
• 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): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2025
• Report Date (Section F): 12/04/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/28/2020
• Device Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/03/2025
• Device Age: 8 YR
• Event Location: Other
• Date Report to Manufacturer: 12/04/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2025
• Date Device Manufactured: 08/28/2017
• 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: 41 YR
• Patient Sex: Female