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	Head Injury (1879)
Date of Event	10/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There is no coupling with the implant after severe head trauma on (b)(6) 2025.Re-implantation is being considered.
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.
Additional Manufacturer Narrative
Additional information: based on the information received, a mechanical damage of the stimulator electronics, which is typical for a severe external impact to the housing, appears likely.Further in situ measurements before the reported trauma show an increased ground path impedance either due to air over the reference contact or a technical failure of the reference electrode.However, to determine and confirm an exact root cause of failure cause a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.
Event or Problem Description
There is no coupling with the implant after severe head trauma on (b)(6) 2025.Re-implantation is being considered.
Event or Problem Description
There is no coupling with the implant after severe head trauma on (b)(6) 2025.The user has been reimplanted.
Additional Manufacturer Narrative
Additional information: based on the information received, a mechanical damage of the stimulator electronics, which is typical for a severe external impact to the housing, appears likely.Further in situ measurements before the reported trauma show an increased ground path impedance either due to air over the reference contact or a technical failure of the reference electrode.However, to determine and confirm an exact root cause of failure cause a device investigation of the explanted device is necessary.Reimplantation has been done but the explanted device has not been received yet.

• 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: 23411081
• Report Number: 9710014-2025-01008
• Device Sequence Number: 18743806
• Product Code: MCM
• UDI-Device Identifier: 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): 09/21/2026

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: 05/03/2026
• Device Model Number: Mi1250 SYNCHRONY 2
• Was Device Available for Evaluation?: No
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 10/27/2025; 10/27/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/04/2025; 09/21/2026
• Date Device Manufactured: 05/03/2023
• 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: 7 YR
• Patient Sex: Female