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

Model Number	MI1250 SYNCHRONY 2 PIN
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
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
At the initial activation the user could only hear on the first 4 electrodes.An x-ray is planned and then it will be decided how to proceed.However, re-positioning is being considered, if the images shows that the electrode array is outside the cochlea.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the electrode migrated partially post-operatively out of cochlea.Further a complete insertion of the active electrode could not be achieved at implantation surgery due to difficult anatomy with 2-3 channels remaining extra-cochlear.As per information received seven channels are deactivated.Reportedly due to complex anatomy no revision surgery is planned, instead the recipient will be monitored by the clinic.The device remains implanted and in use.This is a final report.
Event or Problem Description
At the initial activation the user could only hear on the first 4 electrodes.The user was seen on (b)(6) 2026 and the ent has decided not to intervene, due to the patient's anatomy.The ent believes he will not be able to push the electrode array further in.7 electrodes have been deactivated.The user reports he can now hear better than before, meaning that he can hear noise now, while before was more difficult.The user will be monitored.

• 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: 24413750
• Report Number: 9710014-2026-00179
• Device Sequence Number: 10577504
• Product Code: MCM
• UDI-Device Identifier: 09008737395445
• UDI-Public: (01)09008737395445
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 04/27/2026

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 PIN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/27/2026
• Date Device Manufactured: 08/03/2025
• 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: 76 YR
• Patient Sex: Male