MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SYNCHRONY; Cochlear Implant

Model Number	Mi1250 SYNCHRONY 2
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
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
No coupling is possible to the implant.Parents say that the user start learning walking so it might be he had a head trauma over the implant site.Re-implantation is planned.
Event or Problem Description
Parents say that the user start learning walking so it might be he had a head trauma over the implant site.Re-implantation is planned.
Additional Manufacturer Narrative
Additional information: according to the information received from the field a technical implant failure seems likely.However, to determine an exact root cause device investigation of the explanted device would be necessary.Re-implantation is considered but no date has been scheduled yet.
Event or Problem Description
Parents say that the user start learning walking so it might be he had a head trauma over the implant site.The user has been reimplanted.
Additional Manufacturer Narrative
Conclusion: the device investigation revealed mechanical damage to the stimulator electronics that is typical for severe external impact to the housing.The problems described in the recipient report appear to match the damage found.This is a final report.

• 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 ; +43()577885626
• MDR Report Key: 23290184
• Report Number: 9710014-2025-00950
• Device Sequence Number: 18690336
• Product Code: MCM
• UDI-Device Identifier: 09008737369026
• UDI-Public: (01)09008737369026
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• 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,Followup
• Report Date (Section B): 08/28/2026

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 Expiration Date: 05/03/2023
• Device Model Number: Mi1250 SYNCHRONY 2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2025
• Supplement Date Received by Manufacturer: 10/12/2025; 10/12/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/03/2025; 08/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2026
• 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: 17 MO
• Patient Sex: Male