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	Medical device site infection (4845)
Date of Event	10/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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, the device was explanted due to a middle ear infection which spread to the implant site.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.Additionally, the recipient developed a seroma after a previous revision surgery for middle ear infection, during which two channels were found extra-cochlear.One channel has been outside the cochlea since implantation surgery.Further during revision surgery, two additional channels came out of the cochlea and could not be re-inserted.This is a combined initial and final report.
Event or Problem Description
The user has a discharge from the ear and middle ear due to a middle ear infection.Revision surgery for mastoid examination has taken place on (b)(6) 2025.Reportedly, the patient had a seroma and problems with the processor after this revision surgery.It was dry for about 3 weeks, then it started to ooze.But it resolved with compression.The issues reoccurred; thus, the user needed another surgery.The user has been explanted on (b)(6) 2026 due to the ongoing middle ear infection and seroma.As per device explant information form, it started as a middle ear infection that spread to the level of the implant.

• 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: 24481036
• Report Number: 9710014-2026-00214
• Device Sequence Number: 10126357
• Product Code: MCM
• UDI-Device Identifier: 09008737369026
• UDI-Public: (01)09008737369026
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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 Model Number: MI1250 SYNCHRONY 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 4 YR
• Patient Sex: Male