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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Codes	Impedance Problem (2950); Migration (4003)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
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 user was doing well following initial implantation per audiologist and parent report.Channels 11 and 12 were found to be extra-cochlear at the time of surgery.Facial nerve stimulation was present when using her new maps with charge units above 15.A ct scan has been scheduled on (b)(6).
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the lack of benefit was caused by a migration of the active electrode out of cochlea as five channels were found extra-cochlear at explantation.According to the implant registration card a complete insertion was achieved at implantation surgery.In addition, during device investigation damage to the active electrode caused by device minute mobility was found.Other mechanical damages are attributable to the removal surgery.The reported facial nerve stimulation was likely caused by extra-cochlear stimulation due to the electrode migration.This is a final report.
Event or Problem Description
The user was doing well following initial implantation per audiologist and parent report.Facial nerve stimulation was present when using her new maps with charge units above 15.The user underwent reimplantation surgery on (b)(6) 2026.5 channels were found extra-cochlear.

• 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: 23646623
• Report Number: 9710014-2025-01113
• Device Sequence Number: 20039839
• Product Code: MCM
• UDI-Device Identifier: 09008737395391
• UDI-Public: (01)09008737395391
• 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: 2025
• Device Explanted Year: 2026
• 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): 03/18/2026

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 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: 03/18/2026
• Date Device Manufactured: 07/10/2024
• 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: 15 MO
• Patient Sex: Female