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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Tears (2516); Tissue Breakdown (2681)
Date of Event	02/10/2026
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 device is extruding through the skin.A revision surgery to reposition the implant and do a rotation flap is planned.
Additional Manufacturer Narrative
Conclusion: device investigation of the received parts did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found are attributable to the removal surgery.According to the information received, the device was explanted due to an infection and extrusion of the device through the skin following a trauma.A previous skin flap revision surgery was only temporary successful.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.This is a final report.
Event or Problem Description
The device is extruding through the skin.Reportedly, there was a skin infection and the left device was exposed.Reportedly, there was a trauma leading to the skin breakdown.In (b)(6) 2025, a skin flap revision surgery took place.However, the skin graft failed and the device was 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: 24362109
• Report Number: 9710014-2026-00156
• Device Sequence Number: 15982201
• Product Code: MCM
• UDI-Device Identifier: 09008737366766
• UDI-Public: (01)09008737366766
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: 10/24/2022
• 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: 02/10/2026
• Supplement Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2019
• 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: 7 YR
• Patient Sex: Male