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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Mastoiditis (4835)
Date of Event	10/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been explanted and has been returned to med-el hq where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.
Event or Problem Description
The user was explanted because a right-sided mastoidectomy with ear canal closure due to chronic infections was performed.The infection was a mastoiditis and did not spread to the level of the implant.Additionally, the electrode array had migrated out of the cochlea as confirmed by imaging and is thought to be the reason for poor performance with the device.The user was explanted and reimplanted at a later point.
Additional Manufacturer Narrative
Conslusion: device investigation 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 from the field the device was explanted due to device unrelated chronic infection requiring an ear canal closure.Reportedly the infection did not spread to the implant site.Furthermore, 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.In addition the electrode migrated post-operatively out of cochlea as confirmed by diagnostic imaging.This is a final report.
Event or Problem Description
The user was explanted because a right-sided mastoidectomy with ear canal closure due to chronic infections was performed.The infection was a mastoiditis and did not spread to the level of the implant.Additionally, the electrode array had migrated out of the cochlea as confirmed by imaging and is thought to be the reason for poor performance with the device.The user was explanted and reimplanted at a later point.

• 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: 24923007
• Report Number: 9710014-2026-00372
• Device Sequence Number: 18430204
• Product Code: MCM
• UDI-Device Identifier: 09008737094041
• UDI-Public: (01)09008737094041
• 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: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• 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): 06/02/2026

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: 04/11/2020
• Device Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2025
• 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: 04/01/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 04/20/2026
• Supplement Report FDA Received Date: 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2017
• 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: 26 YR
• Patient Sex: Male