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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
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 has reported that the sound quality has decreased.The user went to the clinic for follow-up on (b)(6) 2025.Audiologist has the user scheduled to return on (b)(6) 2026 to disable extracochlear electrodes.The surgeon reported that they could consider explanting and reimplanting.
Additional Manufacturer Narrative
Additional information: based on the information received from the field, the device was not providing benefit to the recipient due to a partial post-operative active electrode migration out of the cochlea.Further the recipient experienced facial nerve stimulation, which might be caused by extra-cochlear stimulation in the middle ear.Further proceedings are currently unknown.
Event or Problem Description
The user has reported that the sound quality has decreased and is experiencing facial nerve stimulation.The user went to the clinic for follow-up on (b)(6) 2025.Audiologist has the user scheduled to return (b)(6) 2026 to disable extracochlear electrodes.
Additional Manufacturer Narrative
Conclusion: 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.Based on the information received from the field, the device was not providing benefit to the recipient due to a partial post-operative active electrode migration out of the cochlea.Further the recipient experienced facial nerve stimulation, which might be caused by extra-cochlear stimulation in the middle ear.This is a final report.
Event or Problem Description
The user has reported that the sound quality has decreased and is experiencing facial nerve stimulation.The user has been reimplanted.

• 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: 23645886
• Report Number: 9710014-2025-01110
• Device Sequence Number: 14658796
• Product Code: MCM
• UDI-Device Identifier: 09008737395414
• UDI-Public: (01)09008737395414
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 05/06/2026

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: 11/21/2025
• Supplement Date Received by Manufacturer: 11/21/2025; 11/21/2025
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/14/2026; 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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: 21 YR
• Patient Sex: Female